A Phase 1b/2 Study of MEDI4736 with Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma

Study identifier:D4190C00021

ClinicalTrials.gov identifier:NCT02340975

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1b/2 Study of MEDI4736 in Combination with Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects with Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

Medical condition

Gastric or Gastroesophageal Junction Adenocarcinoma

Phase

Phase 1/2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

114

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 31 Mar 2015

Primary Completion Date: 29 Apr 2019

Study Completion Date: 29 Apr 2019

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2020 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Greenville, SC, United States, 29605

Location

Research Site

Tampa, FL, United States, 33612

Location

Research Site

Portland, OR, United States, 97213

Location

Research Site

Nashville, TN, United States, 37203

Location

Research Site

New York, NY, United States, 10032

Location

Research Site

Cleveland, OH, United States, 44106

Location

Research Site

Chicago, IL, United States, 60637

Location

Research Site

Santa Monica, CA, United States, 90404

Arms	Assigned Interventions
Experimental: Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W) Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).	Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Experimental: Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).	Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Experimental: Phase 2 Arm B-M10 mg/kg (Q2W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).	Biological/Vaccine: MEDI4736 MEDI4736 will be administered by IV infusion.
Experimental: Phase 2 Arm C-T10 mg/kg (Q4W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).	Biological/Vaccine: Tremelimumab Tremelimumab will be administered by IV infusion.
Experimental: Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).	Biological/Vaccine: MEDI4736+tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Experimental: Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).	Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in the United States of America, Japan, Korea, Taiwan and Singapore between 31Mar2015 and 29Apr2019.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 114 participants were randomized in the study, out of which 113 participants received study treatment.

Reporting Groups

	Description
Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Participant Flow: Overall Study

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
STARTED	6	27	24	12	25	19
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	6	27	24	12	25	19
Death	6	23	21	7	21	13
Lost to Follow-up	0	0	0	0	2	0
Withdrawal by Subject	0	0	3	3	2	0
Not Specified	0	4	0	2	0	6

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Baseline Measures

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Total
Number of Participants [units: Participants]	6	27	24	12	25	19	113
Age Continuous [units: Years] Mean ± Standard Deviation	70.0 ± 12.7	60.4 ± 13.5	59.8 ± 12.0	52.3 ± 16.0	58.6 ± 10.7	59.9 ± 12.8	59.4 ± 12.9
Sex: Female, Male [units: Participants]
Female	0	7	5	4	9	5	30
Male	6	20	19	8	16	14	83
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	1	7	11	5	12	13	49
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0
White	5	20	13	6	13	6	63
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	1	0	0	1
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	0	1	0	0	1	2
Not Hispanic or Latino	6	27	23	12	25	18	111
Unknown or Not Reported	0	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 1b [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 1b
Measure Description	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 1b [units: Participants]
TEAEs	6
TESAEs	2

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 1b

2. Primary Outcome Measure: Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b [ Time Frame: From first dose of Study drug (Day 1) through 28 days after the administration of MEDI4736 and tremelimumab ]

Measure Type	Primary
Measure Name	Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b
Measure Description	A DLT was defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period (From first dose of Study drug [Day 1] through 28 days after the administration of MEDI4736 and tremelimumab). The DLTs are: any Grade 4 immune-related adverse event (irAE), any Grade >=3 non-irAE, >= Grade 3 colitis, Grade 3 or 4 noninfectious pneumonitis irrespective of duration, Grade 2 pneumonitis, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN. Immune-related AEs are defined as AEs of an immune nature (ie, inflammatory) in the absence of a clear alternative etiology.
Time Frame	From first dose of Study drug (Day 1) through 28 days after the administration of MEDI4736 and tremelimumab
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose limiting toxicity (DLT) evaluable population included all participants in the Phase 1b who received the Study drug and completed safety follow-up through the DLT evaluation period or experience a DLT during the DLT evaluation period (From first dose of Study drug [Day 1] through 28 days after the administration of MEDI4736 and tremelimumab).

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b [units: Participants]	1

No statistical analysis provided for Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b

3. Primary Outcome Measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Primary
Measure Name	Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b
Measure Description	Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b [units: Participants]
Anaemia	1
Lymphopenia	1
Haemoglobin decreased	1
Prothrombin time prolonged	1
Activated partial thromboplastin time prolonged	1
Blood alkaline phosphatase increased	1
Blood bilirubin increased	1
Gamma-glutamyltransferase increased	2
Transaminases increased	1

No statistical analysis provided for Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b

4. Primary Outcome Measure: Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Primary
Measure Name	Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b
Measure Description	Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b [units: Participants]
Pyrexia	1
Weight decreased	1

No statistical analysis provided for Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b

5. Primary Outcome Measure: Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Primary
Measure Name	Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b
Measure Description	Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b [units: Participants]	1

No statistical analysis provided for Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b

6. Primary Outcome Measure: Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b [ Time Frame: Baseline (Day 1) ]

Measure Type	Primary
Measure Name	Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b
Measure Description	The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
Time Frame	Baseline (Day 1)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b [units: Participants]
ECOG 0	4
ECOG 1	2

No statistical analysis provided for Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b

7. Primary Outcome Measure: Percentage of Participants With Objective Response (OR) in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Primary
Measure Name	Percentage of Participants With Objective Response (OR) in Phase 2
Measure Description	OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Percentage of Participants With Objective Response (OR) in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	11.1 (2.4 to 29.2)	0 (0.0 to 14.2)	8.3 (0.2 to 38.5)	4.0 (0.1 to 20.4)	15.8 (3.4 to 39.6)

Statistical Analysis 1 for Percentage of Participants With Objective Response (OR) in Phase 2

Groups^[1]	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W), Phase 2 Arm B-M10 mg/kg (Q2W)
Method^[3]	Fisher Exact
P-Value^[4]	0.2376
Mean Difference (Net)^[5]	11.1
95% Confidence Interval	( -0.7 to 23.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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Statistical Analysis 2 for Percentage of Participants With Objective Response (OR) in Phase 2

Groups^[1]	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W), Phase 2 Arm C-T10 mg/kg (Q4W)
Method^[3]	Fisher Exact
P-Value^[4]	1.0000
Median Difference (Net)^[5]	2.8
95% Confidence Interval	( -16.8 to 22.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

8. Primary Outcome Measure: Progression Free Survival at 6 (PFS-6) Month in Phase 2 [ Time Frame: From Day 1 upto 6 months ]

Measure Type	Primary
Measure Name	Progression Free Survival at 6 (PFS-6) Month in Phase 2
Measure Description	The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
Time Frame	From Day 1 upto 6 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Progression Free Survival at 6 (PFS-6) Month in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	12.1 (3.1 to 27.9)	NA (NA to NA) ^[1]	23.3 (3.6 to 52.9)	12.5 (3.1 to 28.7)	5.3 (0.4 to 21.4)

No statistical analysis provided for Progression Free Survival at 6 (PFS-6) Month in Phase 2

9. Secondary Outcome Measure: Percentage of Participants With Objective Response in Phase 1b [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Objective Response in Phase 1b
Measure Description	OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization of participants or date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Percentage of Participants With Objective Response in Phase 1b [units: Percentage of participants] Number (95% Confidence Interval)	0 (0.0 to 45.9)

No statistical analysis provided for Percentage of Participants With Objective Response in Phase 1b

10. Secondary Outcome Measure: Duration of Stable Disease (DSD) in Phase 1b [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Duration of Stable Disease (DSD) in Phase 1b
Measure Description	The DSD was defined as the time from the date of first dose of study treatment for Phase 1b until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. DSD was analyzed for participants with SD.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	2
Duration of Stable Disease (DSD) in Phase 1b [units: Months] Median (Full Range)	5.4 (3.5 to 7.4)

No statistical analysis provided for Duration of Stable Disease (DSD) in Phase 1b

11. Secondary Outcome Measure: Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b
Measure Description	Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b [units: mm] Median (Full Range)	17.7 (-3.2 to 115.1)

No statistical analysis provided for Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b

12. Secondary Outcome Measure: Percentage of Participants With Disease Control at 16 Weeks in Phase 1b [ Time Frame: From Day 1 up to 16 weeks ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Disease Control at 16 Weeks in Phase 1b
Measure Description	The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
Time Frame	From Day 1 up to 16 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Percentage of Participants With Disease Control at 16 Weeks in Phase 1b [units: Percentage of participants] Number (95% Confidence Interval)	33.3 (4.3 to 77.7)

No statistical analysis provided for Percentage of Participants With Disease Control at 16 Weeks in Phase 1b

13. Secondary Outcome Measure: Percentage of Participants With Disease Control at 24 Weeks in Phase 1b [ Time Frame: From Day 1 up to 24 weeks ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Disease Control at 24 Weeks in Phase 1b
Measure Description	The disease control rate at 24 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
Time Frame	From Day 1 up to 24 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Percentage of Participants With Disease Control at 24 Weeks in Phase 1b [units: Percentage of participants] Number (95% Confidence Interval)	16.7 (0.4 to 64.1)

No statistical analysis provided for Percentage of Participants With Disease Control at 24 Weeks in Phase 1b

14. Secondary Outcome Measure: Progression Free Survival at 6 Month in Phase 1b [ Time Frame: From Day 1 upto 6 months ]

Measure Type	Secondary
Measure Name	Progression Free Survival at 6 Month in Phase 1b
Measure Description	The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Phase 1b participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
Time Frame	From Day 1 upto 6 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Measured Values

	Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	6
Progression Free Survival at 6 Month in Phase 1b [units: Percentage of participants] Number (95% Confidence Interval)	16.7 (0.8 to 51.7)

No statistical analysis provided for Progression Free Survival at 6 Month in Phase 1b

15. Secondary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 2 [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 2
Measure Description	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 2 [units: Participants]
TEAEs	27	23	12	22	18
TESAEs	14	16	10	15	12

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Phase 2

16. Secondary Outcome Measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2 [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2
Measure Description	Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2 [units: Participants]
Anaemia	9	3	3	7	4
Lymphocyte count decreased	1	1	1	0	0
White blood cell count decreased	0	0	1	0	0
International normalised ratio increased	3	0	1	1	0
Activated partial thromboplastin time prolonged	1	0	0	0	0
Platelet count decreased	0	0	1	0	0
Blood fibrinogen decreased	0	0	0	0	1
Hepatic function abnormal	0	1	1	0	0
Alanine aminotransferase increased	2	1	2	2	2
Aspartate aminotransferase increased	2	2	3	3	2
Blood alkaline phosphatase increased	0	2	1	2	2
Blood bilirubin increased	0	2	0	1	1
Gamma-glutamyltransferase increased	0	0	0	2	1
Hyperthyroidism	1	0	1	0	0
Hypothyroidism	0	0	0	4	0
Blood thyroid stimulating hormone increased	3	0	0	0	0
Thyroxine free decreased	1	0	0	0	0
Tri-iodothyronine free decreased	2	0	0	0	0

No statistical analysis provided for Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2

17. Secondary Outcome Measure: Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2 [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2
Measure Description	Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2 [units: Participants]
Atrial fibrillation	1	1	1	0	0
Bradycardia	0	0	1	1	0
Hypertension	1	0	0	1	1
Hypotension	6	3	1	2	1
Hypoxia	2	0	1	0	0
Pyrexia	5	7	2	4	2
Respiratory distress	1	0	0	0	0
Sinus tachycardia	3	1	0	0	0
Tachycardia	1	0	1	1	0
Weight decreased	3	4	1	5	2

No statistical analysis provided for Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2

18. Secondary Outcome Measure: Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2 [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2
Measure Description	Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2 [units: Participants]
Sinus tachycardia	3	1	0	0	0
Angina pectoris	1	0	0	1	0
Ventricular tachycardia	1	0	1	0	0
Tachycardia	1	0	1	1	0
Atrial fibrillation	1	1	1	0	0
Cardiac failure congestive	1	0	0	0	0
Atrial tachycardia	0	1	0	0	0
Bradycardia	0	0	1	1	0
Pericardial effusion	0	0	1	0	0
Cardiac failure	0	0	0	0	1

No statistical analysis provided for Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2

19. Secondary Outcome Measure: Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2 [ Time Frame: Baseline (Day 1) ]

Measure Type	Secondary
Measure Name	Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2
Measure Description	The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
Time Frame	Baseline (Day 1)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2 [units: Participants]
ECOG 0	9	9	4	11	11
ECOG 1	18	14	8	14	8

No statistical analysis provided for Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2

20. Secondary Outcome Measure: Percentage of Participants With Disease Control at 16 Weeks in Phase 2 [ Time Frame: From Day 1 up to 16 weeks ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Disease Control at 16 Weeks in Phase 2
Measure Description	The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
Time Frame	From Day 1 up to 16 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Percentage of Participants With Disease Control at 16 Weeks in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	18.5 (6.3 to 38.1)	12.5 (2.7 to 32.4)	16.7 (2.1 to 48.4)	28.0 (12.1 to 49.4)	21.1 (6.1 to 45.6)

No statistical analysis provided for Percentage of Participants With Disease Control at 16 Weeks in Phase 2

21. Secondary Outcome Measure: Percentage of Participants With Disease Control at 24 Weeks in Phase 2 [ Time Frame: From Day 1 up to 24 weeks ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Disease Control at 24 Weeks in Phase 2
Measure Description	The disease control rate at 24 weeks was defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
Time Frame	From Day 1 up to 24 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Percentage of Participants With Disease Control at 24 Weeks in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	11.1 (2.4 to 29.2)	0 (0.0 to 14.2)	16.7 (2.1 to 48.4)	12.0 (2.5 to 31.2)	15.8 (3.4 to 39.6)

No statistical analysis provided for Percentage of Participants With Disease Control at 24 Weeks in Phase 2

22. Secondary Outcome Measure: Duration of Response (DoR) in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR) in Phase 2
Measure Description	The DoR was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression according to RECIST v1.1 that occurred subsequently after response or death due to any cause, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline. Kaplan Meier method was used to evaluate DoR.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with OR were analyzed for the specified outcome measure.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	3	0	1	1	3
Duration of Response (DoR) in Phase 2 [units: Months] Median (Full Range)	NA (2.0 to 22.4) ^[1]		4.6 (4.6 to 4.6)	7.4 (7.4 to 7.4)	3.1 (1.9 to 7.4)

No statistical analysis provided for Duration of Response (DoR) in Phase 2

23. Secondary Outcome Measure: Time to Response (TTR) in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Time to Response (TTR) in Phase 2
Measure Description	TTR: time from date of randomization of participants for Arm A, B, and C or date of first dose of study drug for Arm D and Arm E until first documented OR per RECIST v1.1. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization/date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in SOD of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD; PD: at least 20% increase in SOD of target lesions from smallest sum (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method used to evaluate TTR.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with OR were analyzed for the specified outcome measure.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	3	0	1	1	3
Time to Response (TTR) in Phase 2 [units: Months] Median (Full Range)	1.9 (1.9 to 3.7)		2.7 (2.7 to 2.7)	7.2 (7.2 to 7.2)	1.8 (1.7 to 1.8)

No statistical analysis provided for Time to Response (TTR) in Phase 2

24. Secondary Outcome Measure: Duration of Stable Disease in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Duration of Stable Disease in Phase 2
Measure Description	The DSD was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5 mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. DSD was analyzed for participants with SD.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	4	3	1	6	1
Duration of Stable Disease in Phase 2 [units: Months] Median (Full Range)	3.5 (2.8 to 3.7)	3.6 (3.5 to 4.3)	7.7 (7.7 to 7.7)	4.2 (3.5 to 7.2)	3.5 (3.5 to 3.5)

No statistical analysis provided for Duration of Stable Disease in Phase 2

25. Secondary Outcome Measure: Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2
Measure Description	Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with any reduction in tumor size were analyzed for the specified outcome measure.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	25	17	9	21	17
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2 [units: mm] Median (Full Range)	8.00 (-86.7 to 123.0)	21.20 (-60.0 to 101.2)	-4.00 (-61.1 to 67.2)	0.00 (-58.4 to 116.2)	3.00 (-100.0 to 54.8)

No statistical analysis provided for Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2

26. Secondary Outcome Measure: Progression Free Survival in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Progression Free Survival in Phase 2
Measure Description	The PFS was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study treatment for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Progression Free Survival in Phase 2 [units: Months] Median (95% Confidence Interval)	1.8 (1.6 to 2.8)	1.6 (1.0 to 1.8)	1.7 (0.8 to 7.3)	1.8 (1.6 to 3.5)	1.8 (1.6 to 1.9)

No statistical analysis provided for Progression Free Survival in Phase 2

27. Secondary Outcome Measure: Progression Free Survival at 9 Month (PFS-9) in Phase 2 [ Time Frame: From Day 1 up to 9 months ]

Measure Type	Secondary
Measure Name	Progression Free Survival at 9 Month (PFS-9) in Phase 2
Measure Description	The PFS-9 is the 9-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 9 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, C participants or the date of first dose of study drug for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
Time Frame	From Day 1 up to 9 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Progression Free Survival at 9 Month (PFS-9) in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	12.1 (3.1 to 27.9)	NA (NA to NA) ^[1]	NA (NA to NA) ^[1]	4.2 (0.3 to 17.6)	5.3 (0.4 to 21.4)

No statistical analysis provided for Progression Free Survival at 9 Month (PFS-9) in Phase 2

28. Secondary Outcome Measure: Overall Survival (OS) in Phase 2 [ Time Frame: From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month) ]

Measure Type	Secondary
Measure Name	Overall Survival (OS) in Phase 2
Measure Description	The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until death due to any cause. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS.
Time Frame	From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Overall Survival (OS) in Phase 2 [units: Months] Median (Full Range)	9.2 (1.6 to 32.0)	3.4 (0.8 to 9.5)	7.7 (0.8 to 33.8)	10.7 (1.0 to 30.7)	7.0 (0.6 to 18.8)

No statistical analysis provided for Overall Survival (OS) in Phase 2

29. Secondary Outcome Measure: Overall Survival at 12 Months in Phase 2 [ Time Frame: From Day 1 up to 12 months ]

Measure Type	Secondary
Measure Name	Overall Survival at 12 Months in Phase 2
Measure Description	The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until 12 months. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS and 95% confidence interval.
Time Frame	From Day 1 up to 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Overall Survival at 12 Months in Phase 2 [units: Percentage of participants] Number (95% Confidence Interval)	37.0 (19.6 to 54.6)	NA (NA to NA) ^[1]	13.1 (0.7 to 43.6)	40.7 (20.2 to 60.3)	29.2 (10.9 to 50.5)

No statistical analysis provided for Overall Survival at 12 Months in Phase 2

30. Secondary Outcome Measure: Percentage of Participants With Objective Response With Positive Interferon gamma (IFN-γ) Gene Expression in Phase 2 [ Time Frame: Day 1 through Day 30 post EOT (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Objective Response With Positive Interferon gamma (IFN-γ) Gene Expression in Phase 2
Measure Description	Percentage of participants with OR with positive IFN-γ gene expression is reported. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
Time Frame	Day 1 through Day 30 post EOT (approximately 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

Description

Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	19
Percentage of Participants With Objective Response With Positive Interferon gamma (IFN-γ) Gene Expression in Phase 2 [units: Percenatge of Participants] Number (95% Confidence Interval)	15.8 (3.4 to 39.6)

No statistical analysis provided for Percentage of Participants With Objective Response With Positive Interferon gamma (IFN-γ) Gene Expression in Phase 2

31. Secondary Outcome Measure: Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2 [ Time Frame: Day 1 through Day 30 post EOT (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2
Measure Description	Percentage of participants with PFS at 6 month with positive IFN-γ gene expression is reported. The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
Time Frame	Day 1 through Day 30 post EOT (approximately 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Only those participants were analyzed who were at risk at 6 months.

Reporting Groups

Description

Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Measured Values

	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	1
Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2 [units: Percentage of Participants] Number (95% Confidence Interval)	5.3 (0.4 to 21.4)

No statistical analysis provided for Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2

32. Secondary Outcome Measure: Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status [ Time Frame: Day 1 through Day 30 post EOT (approximately 4 years and one month) ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status
Measure Description	Percentage of participants with objective response in Phase 2 by programmed death-ligand (PD-L1) status is reported. PD-L1 is a protein that may be found on some normal cells and in higher-than-normal amounts on some types of cancer cells. It plays a role in regulating the immune response against some types of cancers and therefore, is the target for some anticancer drugs. PD-L1 status was based on the percentage of tumor cells from baseline tumor tissue samples with PD-L1 membrane staining: PD-L1 high if >= 1% tumor cells (better response), PD-L1 low/neg if < 1% tumor cells (low response).
Time Frame	Day 1 through Day 30 post EOT (approximately 4 years and one month)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Measured Values

	Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm B-M10 mg/kg (Q2W)	Phase 2 Arm C-T10 mg/kg (Q4W)	Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
Number of Participants Analyzed [units:participants]	27	24	12	25	19
Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status [units: Percentage of participants] Number (95% Confidence Interval)
PD-L1 high	13.3 (1.7 to 40.5)	0 (0.0 to 28.5)	0 (0.0 to 41.0)	0 (0.0 to 52.2)	33.3 (7.5 to 70.1)
PD-L1 low/negative	11.1 (0.3 to 48.2)	0 (0.0 to 33.6)	25.0 (0.6 to 80.6)	0 (0.0 to 21.8)	0 (0.0 to 60.2)

No statistical analysis provided for Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status

Serious Adverse Events

Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Additional Description	No text entered.

Reporting Groups

	Description
Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Serious Adverse Events

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Phase 2 Arm B-M10 mg/kg (Q2W)

Phase 2 Arm C-T10 mg/kg (Q4W)

Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Total, serious adverse events

# participants affected / at risk

2/6 (33.33%)

14/27 (51.85%)

16/24 (66.67%)

10/12 (83.33%)

15/25 (60.00%)

12/19 (63.16%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Cardiac disorders

Cardiac failure congestive¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Sinus tachycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Endocrine disorders

Adrenal insufficiency¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

Endocrine disorders

Hypophysitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

1/24 (4.17%)

2/12 (16.67%)

1/25 (4.00%)

2/19 (10.53%)

# events

Gastrointestinal disorders

Ascites¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Colitis¹,^†

# participants affected / at risk

0/6 (0.00%)

4/27 (14.81%)

0/24 (0.00%)

2/12 (16.67%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

1/24 (4.17%)

1/12 (8.33%)

2/25 (8.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Gastric perforation¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Gastrointestinal haemorrhage¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Haematemesis¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Large intestinal obstruction¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Melaena¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Obstruction gastric¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Upper gastrointestinal haemorrhage¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

2/19 (10.53%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

Chest discomfort¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

General physical health deterioration¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Peripheral swelling¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Hepatobiliary disorders

Bile duct obstruction¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Hepatobiliary disorders

Hepatic function abnormal¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Hepatobiliary disorders

Jaundice¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Infections and infestations

Enterococcal bacteraemia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Infections and infestations

Enterocolitis infectious¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

2/24 (8.33%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Injury, poisoning and procedural complications

Infusion related reaction¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Blood bilirubin increased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Glomerular filtration rate decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Transaminases increased¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Failure to thrive¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hypophagia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Bone pain¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant pleural effusion¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour haemorrhage¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Psychiatric disorders

Hallucination¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Psychiatric disorders

Mental status changes¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

2/19 (10.53%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Renal disorder¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Tubulointerstitial nephritis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Urinary tract obstruction¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Apnoea¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

2/24 (8.33%)

1/12 (8.33%)

1/25 (4.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory arrest¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory distress¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis acneiform¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash maculo-papular¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Vascular disorders

Embolism¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA
2	Term from vocabulary, MedDRA 22.0

Other Adverse Events

Time Frame	Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)	Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm B-M10 mg/kg (Q2W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Phase 2 Arm C-T10 mg/kg (Q4W)	Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)	Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Other Adverse Events

Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)

Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Phase 2 Arm B-M10 mg/kg (Q2W)

Phase 2 Arm C-T10 mg/kg (Q4W)

Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)

Total, other (not including serious) adverse events

# participants affected / at risk

6/6 (100.00%)

27/27 (100.00%)

22/24 (91.67%)

12/12 (100.00%)

22/25 (88.00%)

18/19 (94.74%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/6 (16.67%)

9/27 (33.33%)

3/24 (12.50%)

3/12 (25.00%)

8/25 (32.00%)

4/19 (21.05%)

# events

Blood and lymphatic system disorders

Iron deficiency anaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Blood and lymphatic system disorders

Lymphopenia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Pericardial effusion¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Sinus tachycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Cardiac disorders

Ventricular tachycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Ear and labyrinth disorders

Tinnitus¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Endocrine disorders

Endocrine disorder¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Endocrine disorders

Hyperthyroidism¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

4/25 (16.00%)

0/19 (0.00%)

# events

Eye disorders

Glaucoma¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Abdominal discomfort¹,^†

# participants affected / at risk

1/6 (16.67%)

3/27 (11.11%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

3/24 (12.50%)

2/12 (16.67%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

2/6 (33.33%)

6/27 (22.22%)

3/24 (12.50%)

4/12 (33.33%)

5/25 (20.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Abdominal pain lower¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

2/12 (16.67%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

2/19 (10.53%)

# events

Gastrointestinal disorders

Aphthous ulcer¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Ascites¹,^†

# participants affected / at risk

0/6 (0.00%)

4/27 (14.81%)

0/24 (0.00%)

3/12 (25.00%)

4/25 (16.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Colitis¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

2/6 (33.33%)

9/27 (33.33%)

5/24 (20.83%)

4/12 (33.33%)

3/25 (12.00%)

5/19 (26.32%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/6 (16.67%)

9/27 (33.33%)

3/24 (12.50%)

5/12 (41.67%)

4/25 (16.00%)

2/19 (10.53%)

# events

Gastrointestinal disorders

Dry mouth¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

2/12 (16.67%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

1/24 (4.17%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

2/24 (8.33%)

3/12 (25.00%)

2/25 (8.00%)

3/19 (15.79%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Haematemesis¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Haematochezia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Haemorrhoids¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Melaena¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

3/6 (50.00%)

7/27 (25.93%)

5/24 (20.83%)

4/12 (33.33%)

8/25 (32.00%)

6/19 (31.58%)

# events

Gastrointestinal disorders

Oesophageal haemorrhage¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Gastrointestinal disorders

Proctalgia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Retching¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Stomatitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

3/24 (12.50%)

3/12 (25.00%)

8/25 (32.00%)

4/19 (21.05%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

6/24 (25.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

Chills¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

2/25 (8.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

3/6 (50.00%)

11/27 (40.74%)

6/24 (25.00%)

5/12 (41.67%)

9/25 (36.00%)

5/19 (26.32%)

# events

General disorders and administration site conditions

Gait disturbance¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

2/19 (10.53%)

# events

General disorders and administration site conditions

Localised oedema¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Malaise¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

Medical device site pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Oedema¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

0/6 (0.00%)

6/27 (22.22%)

1/24 (4.17%)

3/12 (25.00%)

5/25 (20.00%)

4/19 (21.05%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/6 (16.67%)

5/27 (18.52%)

6/24 (25.00%)

2/12 (16.67%)

3/25 (12.00%)

2/19 (10.53%)

# events

Hepatobiliary disorders

Cholangitis acute¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Infections and infestations

Ear infection¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Injury, poisoning and procedural complications

Skin abrasion¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Injury, poisoning and procedural complications

Torus fracture¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Activated partial thromboplastin time prolonged¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

1/24 (4.17%)

2/12 (16.67%)

2/25 (8.00%)

2/19 (10.53%)

# events

Investigations

Amylase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

2/12 (16.67%)

2/25 (8.00%)

2/19 (10.53%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

2/24 (8.33%)

3/12 (25.00%)

3/25 (12.00%)

2/19 (10.53%)

# events

Investigations

Bilirubin conjugated increased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Blood albumin decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

2/12 (16.67%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Blood alkaline phosphatase increased¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

2/24 (8.33%)

1/12 (8.33%)

2/25 (8.00%)

2/19 (10.53%)

# events

Investigations

Blood bilirubin increased¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

Investigations

Blood fibrinogen decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Investigations

Blood thyroid stimulating hormone increased¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Gamma-glutamyltransferase increased¹,^†

# participants affected / at risk

2/6 (33.33%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Investigations

Haemoglobin decreased¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

International normalised ratio increased¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Investigations

Lipase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

2/12 (16.67%)

1/25 (4.00%)

3/19 (15.79%)

# events

Investigations

Lymphocyte count decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Prothrombin time prolonged¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Tri-iodothyronine free decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Investigations

Weight decreased¹,^†

# participants affected / at risk

1/6 (16.67%)

3/27 (11.11%)

4/24 (16.67%)

1/12 (8.33%)

5/25 (20.00%)

2/19 (10.53%)

# events

Investigations

Weight increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

0/6 (0.00%)

10/27 (37.04%)

8/24 (33.33%)

5/12 (41.67%)

9/25 (36.00%)

3/19 (15.79%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

2/24 (8.33%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

7/27 (25.93%)

1/24 (4.17%)

0/12 (0.00%)

1/25 (4.00%)

1/19 (5.26%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

1/25 (4.00%)

2/19 (10.53%)

# events

Metabolism and nutrition disorders

Hypernatraemia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hypoalbuminaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

4/27 (14.81%)

1/24 (4.17%)

3/12 (25.00%)

5/25 (20.00%)

3/19 (15.79%)

# events

Metabolism and nutrition disorders

Hypocalcaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

3/24 (12.50%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

2/12 (16.67%)

2/25 (8.00%)

1/19 (5.26%)

# events

Metabolism and nutrition disorders

Hypomagnesaemia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

3/24 (12.50%)

1/12 (8.33%)

2/25 (8.00%)

3/19 (15.79%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

2/6 (33.33%)

5/27 (18.52%)

1/24 (4.17%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Metabolism and nutrition disorders

Hypophosphataemia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

2/24 (8.33%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

3/25 (12.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

0/6 (0.00%)

6/27 (22.22%)

2/24 (8.33%)

3/12 (25.00%)

6/25 (24.00%)

1/19 (5.26%)

# events

Musculoskeletal and connective tissue disorders

Bone pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Musculoskeletal and connective tissue disorders

Flank pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Musculoskeletal and connective tissue disorders

Groin pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

2/12 (16.67%)

1/25 (4.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

2/12 (16.67%)

3/25 (12.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal stiffness¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

1/25 (4.00%)

0/19 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

3/25 (12.00%)

0/19 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cancer pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour haemorrhage¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

2/19 (10.53%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

2/12 (16.67%)

1/25 (4.00%)

1/19 (5.26%)

# events

Nervous system disorders

Aphonia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

1/6 (16.67%)

3/27 (11.11%)

0/24 (0.00%)

3/12 (25.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

2/24 (8.33%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Hypoaesthesia¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Lethargy¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Nervous system disorders

Migraine¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Neuropathy peripheral¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

2/12 (16.67%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Peripheral sensory neuropathy¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Nervous system disorders

Taste disorder¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Psychiatric disorders

Agitation¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

1/24 (4.17%)

1/12 (8.33%)

2/25 (8.00%)

0/19 (0.00%)

# events

Psychiatric disorders

Delirium¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

Psychiatric disorders

Depressed mood¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

0/6 (0.00%)

7/27 (25.93%)

1/24 (4.17%)

3/12 (25.00%)

3/25 (12.00%)

2/19 (10.53%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Renal and urinary disorders

Dysuria¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Nephropathy toxic¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Renal and urinary disorders

Pollakiuria¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Renal and urinary disorders

Urinary retention¹,^†

# participants affected / at risk

1/6 (16.67%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Reproductive system and breast disorders

Genital erosion¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Reproductive system and breast disorders

Testicular pain¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Atelectasis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchospasm¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

1/6 (16.67%)

6/27 (22.22%)

2/24 (8.33%)

1/12 (8.33%)

2/25 (8.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

2/6 (33.33%)

10/27 (37.04%)

2/24 (8.33%)

3/12 (25.00%)

2/25 (8.00%)

3/19 (15.79%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

1/6 (16.67%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hiccups¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

1/24 (4.17%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

0/6 (0.00%)

2/27 (7.41%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Lung hyperinflation¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

2/24 (8.33%)

1/12 (8.33%)

1/25 (4.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

2/24 (8.33%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Respiratory, thoracic and mediastinal disorders

Stridor¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Tachypnoea¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Actinic keratosis¹,^†

# participants affected / at risk

1/6 (16.67%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

2/24 (8.33%)

0/12 (0.00%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Skin and subcutaneous tissue disorders

Dermatitis acneiform¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

2/12 (16.67%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

2/12 (16.67%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

0/12 (0.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Night sweats¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

2/6 (33.33%)

5/27 (18.52%)

0/24 (0.00%)

5/12 (41.67%)

6/25 (24.00%)

3/19 (15.79%)

# events

Skin and subcutaneous tissue disorders

Psoriasis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

0/6 (0.00%)

4/27 (14.81%)

0/24 (0.00%)

3/12 (25.00%)

0/25 (0.00%)

1/19 (5.26%)

# events

Skin and subcutaneous tissue disorders

Rash maculo-papular¹,^†

# participants affected / at risk

0/6 (0.00%)

3/27 (11.11%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Skin and subcutaneous tissue disorders

Skin ulcer¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

1/19 (5.26%)

# events

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

1/12 (8.33%)

1/25 (4.00%)

1/19 (5.26%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

0/6 (0.00%)

1/27 (3.70%)

0/24 (0.00%)

0/12 (0.00%)

2/25 (8.00%)

1/19 (5.26%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/6 (0.00%)

5/27 (18.52%)

2/24 (8.33%)

1/12 (8.33%)

3/25 (12.00%)

1/19 (5.26%)

# events

Vascular disorders

Thrombophlebitis superficial¹,^†

# participants affected / at risk

0/6 (0.00%)

0/27 (0.00%)

0/24 (0.00%)

1/12 (8.33%)

0/25 (0.00%)

0/19 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA
2	Term from vocabulary, MedDRA 22.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Shahram Rahimian
Organization:	MedImmune, LLC
Phone	+1-800-236-9933
E-mail:	[email protected]

Documents available

Redacted D4190C00021 SAP v3.0 final
Download
Protocol D4190C00021_Redacted_Final_April2020_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study Locator Service

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

MedImmune, LLC MedImmune, LLC

MedImmune LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site