Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically Ventilated Subjects - EVADE

Study identifier:D5470C00004

ClinicalTrials.gov identifier:NCT02696902

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

Medical condition

Pseudomonas aeruginosa

Phase

Phase 2

Healthy volunteers

Study drug

MEDI3902

Sex

All

Actual Enrollment

188

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 25 Mar 2016

Primary Completion Date: 04 Dec 2019

Study Completion Date: 04 Dec 2019

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2020 by MedImmune, LLC

Collaborators

INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET, Antibacterial Resistance Leadership Group (ARLG), National Institute of Allergy and Infectious Disease (NIAID)

Inclusion and exclusion criteria

Location

Research Site

Limoges, France, 87042

Location

Research Site

Barcelona, Spain, 08036

Location

Research Site

Madrid, Spain, 28040

Location

Research Site

Oviedo, Spain, 33011

Location

Research Site

Tours, France, 37000

Location

Research Site

Clermont-ferrand, France, 63003

Location

Research Site

Getafe, Spain, 28905

Location

Research Site

Nancy, France, 54035

Arms	Assigned Interventions
Experimental: MEDI3902 500 mg Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.	Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902.
Placebo Comparator: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902.	Other: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902.
Experimental: MEDI3902 1500 mg Participants will receive a single IV dose of 1500 mg MEDI3902.	Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 188 participants were assigned to the study treatment groups. Out of 188 participants, 4 participants did not receive the study treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Participant Flow: Overall Study

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
STARTED	85	16	87
Treated	83	16	85
COMPLETED	63	12	59
NOT COMPLETED	22	4	28
Lost to Follow-up	0	1	1
Withdrawal by Subject	0	0	1
Death	19	3	24
Participant not fit post-randomization	0	0	1
Participant not eligible (negative PCR)	0	0	1
Principal investigator's decision	1	0	0
Sponsor's decision	1	0	0
Transferred to other hospital	1	0	0

Baseline Characteristics

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

The intent-to-treat (ITT) population is all randomized participants, grouped according to assigned treatment.

Reporting Groups

	Description
Placebo	Of the 85 participants, 83 participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Of the 87 participants, 85 participants received single IV dose of 1500 mg MEDI3902.

Baseline Measures

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg	Total
Number of Participants [units: Participants]	85	16	87	188
Age Continuous [units: Years] Mean ± Standard Deviation	64.4 ± 13.0	62.7 ± 9.3	60.6 ± 15.1	62.5 ± 13.8
Sex: Female, Male [units: Participants]
Female	22	6	32	60
Male	63	10	55	128
Race/Ethnicity, Customized [units: Participants]
Asian	1	0	0	1
Black or African American	4	0	2	6
Native Hawaiian or Other Pacific Islander	1	0	0	1
White	77	16	83	176
Other	2	0	2	4

Outcome Measures

1. Primary Outcome Measure: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa [ Time Frame: Day 1 through Day 22 ]

Measure Type	Primary
Measure Name	Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa
Measure Description	Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Time Frame	Day 1 through Day 22
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.
The modified intent to treat (mITT) population included all randomized and treated participants, grouped according to assigned treatment.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	83	16	85
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa [units: Percentage of participants]	18.1	12.5	22.4

Statistical Analysis 1 for Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

Groups^[1]	Placebo, MEDI3902 1500 mg
Method^[3]	Other [Poisson regression with robust variance]
P-Value^[4]	0.491
Other^[5]	-23.7
80% Confidence Interval	( -83.8 to 16.8 )

[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.

2. Primary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 through Day 50 ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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. The 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 through Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	83	16	85
Number of Participants With Treatment-emergent Adverse Events (TEAEs) [units: Participants]	81	15	84

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events (TEAEs)

3. Primary Outcome Measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 through Day 50 ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Measure Description	An 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.
Time Frame	Day 1 through Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	83	16	85
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [units: Participants]	35	4	38

No statistical analysis provided for Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

4. Primary Outcome Measure: Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) [ Time Frame: Day 1 through Day 50 ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Measure Description	An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.
Time Frame	Day 1 through Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	83	16	85
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) [units: Participants]	1	0	2

No statistical analysis provided for Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)

5. Secondary Outcome Measure: Maximum Observed Concentration (Cmax) of MEDI3902 [ Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Maximum Observed Concentration (Cmax) of MEDI3902
Measure Description	The Cmax of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	16	84
Maximum Observed Concentration (Cmax) of MEDI3902 [units: mcg/mL] Mean (Standard Deviation)	87.6 (23.9)	299 (94.1)

No statistical analysis provided for Maximum Observed Concentration (Cmax) of MEDI3902

6. Secondary Outcome Measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 [ Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
Measure Description	The AUC0-inf of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	16	81
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 [units: day*mcg/mL] Mean (Standard Deviation)	440 (135)	1510 (675)

No statistical analysis provided for Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902

7. Secondary Outcome Measure: Clearance (CL) of MEDI3902 [ Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Clearance (CL) of MEDI3902
Measure Description	The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	16	81
Clearance (CL) of MEDI3902 [units: L/day] Mean (Standard Deviation)	1.31 (0.638)	1.27 (0.86)

No statistical analysis provided for Clearance (CL) of MEDI3902

8. Secondary Outcome Measure: Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose [ Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22 ]

Measure Type	Secondary
Measure Name	Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
Measure Description	Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
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.
The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	16	84
Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose [units: Percentage of participants]	50	80.6

No statistical analysis provided for Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose

9. Secondary Outcome Measure: Terminal Elimination Half-life (t1/2) of MEDI3902 [ Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Terminal Elimination Half-life (t1/2) of MEDI3902
Measure Description	The t1/2 of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.

Reporting Groups

	Description
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	16	81
Terminal Elimination Half-life (t1/2) of MEDI3902 [units: day] Mean (Standard Deviation)	6.56 (4.03)	5.65 (2.69)

No statistical analysis provided for Terminal Elimination Half-life (t1/2) of MEDI3902

10. Secondary Outcome Measure: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment [ Time Frame: Day 1 (predose), Day 15, Day 29, Day 50 ]

Measure Type	Secondary
Measure Name	Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment
Measure Description	Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with < 16 weeks between first and last positive).
Time Frame	Day 1 (predose), Day 15, Day 29, Day 50
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.
The As-treated population is all treated participants, grouped according to actual treatment received.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Measured Values

	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Number of Participants Analyzed [units:participants]	83	16	85
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment [units: Participants]
Positive at baseline and post-baseline	3	2	1
Persistent positive	4	2	4
Transient positive	2	2	8

No statistical analysis provided for Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment

Serious Adverse Events

Time Frame	Day 1 through Day 50
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Serious Adverse Events

Placebo

MEDI3902 500 mg

MEDI3902 1500 mg

Total, serious adverse events

# participants affected / at risk

35/83 (42.17%)

4/16 (25.00%)

38/85 (44.71%)

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

5/83 (6.02%)

1/16 (6.25%)

1/85 (1.18%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Cardiac disorders

Cardiogenic shock¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Myocarditis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Cardiac disorders

Pulseless electrical activity¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Sinus node dysfunction¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Ear and labyrinth disorders

Deafness¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Duodenal ulcer¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Intestinal haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Pancreatitis¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Death¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

General disorders and administration site conditions

General physical health deterioration¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Multiple organ dysfunction syndrome¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

2/85 (2.35%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Acinetobacter bacteraemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Bacterial sepsis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Biliary tract infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Brain abscess¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Bronchitis bacterial¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Burkholderia cepacia complex infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Candida sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Endocarditis enterococcal¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Infections and infestations

Escherichia sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Klebsiella bacteraemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Klebsiella sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Peritonitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Pneumonia pseudomonal¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Pseudomonal bacteraemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Pseudomonal sepsis¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

3/85 (3.53%)

# events

Infections and infestations

Staphylococcal sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Post procedural haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Weaning failure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Oxygen saturation decreased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Spinal pain¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

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

Squamous cell carcinoma¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Brain injury¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Coma¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Haemorrhagic stroke¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Ischaemic stroke¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Seizure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Product issues

Device occlusion¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Chronic kidney disease¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Polyuria¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

4/85 (4.71%)

# events

Respiratory, thoracic and mediastinal disorders

Asphyxia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Aspiration¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Atelectasis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Lower respiratory tract congestion¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Mediastinal haemorrhage¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory arrest¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

4/85 (4.71%)

# events

Vascular disorders

Shock¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

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

Other Adverse Events

Time Frame	Day 1 through Day 50
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Placebo	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
MEDI3902 500 mg	Participants received single IV dose of 500 mg MEDI3902.
MEDI3902 1500 mg	Participants received single IV dose of 1500 mg MEDI3902.

Other Adverse Events

Placebo

MEDI3902 500 mg

MEDI3902 1500 mg

Total, other (not including serious) adverse events

# participants affected / at risk

79/83 (95.18%)

15/16 (93.75%)

82/85 (96.47%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Blood and lymphatic system disorders

Anaemia of chronic disease¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

4/85 (4.71%)

# events

Blood and lymphatic system disorders

Blood loss anaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Blood and lymphatic system disorders

Haemolytic anaemia¹,^†

# participants affected / at risk

5/83 (6.02%)

0/16 (0.00%)

8/85 (9.41%)

# events

Blood and lymphatic system disorders

Iron deficiency anaemia¹,^†

# participants affected / at risk

7/83 (8.43%)

1/16 (6.25%)

2/85 (2.35%)

# events

Blood and lymphatic system disorders

Leukocytosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Blood and lymphatic system disorders

Microcytic anaemia¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

0/85 (0.00%)

# events

Blood and lymphatic system disorders

Normocytic anaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

Blood and lymphatic system disorders

Splenomegaly¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

4/85 (4.71%)

# events

Blood and lymphatic system disorders

Thrombocytosis¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

3/83 (3.61%)

2/16 (12.50%)

4/85 (4.71%)

# events

Cardiac disorders

Atrial tachycardia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

3/85 (3.53%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

Cardiac disorders

Cardiac failure congestive¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Cardiogenic shock¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Cardiac disorders

Coronary artery occlusion¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Cardiac disorders

Cyanosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Cardiac disorders

Mitral valve stenosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Sinus bradycardia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Sinus tachycardia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Supraventricular tachycardia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

7/83 (8.43%)

0/16 (0.00%)

3/85 (3.53%)

# events

Cardiac disorders

Ventricular dysfunction¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Cardiac disorders

Ventricular tachycardia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Ear and labyrinth disorders

Ear pain¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Ear and labyrinth disorders

Excessive cerumen production¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Endocrine disorders

Adrenal insufficiency¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Endocrine disorders

Diabetes insipidus¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Endocrine disorders

Euthyroid sick syndrome¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Endocrine disorders

Hyperprolactinaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Eye disorders

Blindness unilateral¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Eye disorders

Dry eye¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Eye disorders

Noninfective conjunctivitis¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Eye disorders

Ocular hyperaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Eye disorders

Pupils unequal¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

6/83 (7.23%)

2/16 (12.50%)

3/85 (3.53%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Aerophagia¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Anal incontinence¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Colitis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

11/83 (13.25%)

4/16 (25.00%)

11/85 (12.94%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

11/83 (13.25%)

4/16 (25.00%)

12/85 (14.12%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

6/85 (7.06%)

# events

Gastrointestinal disorders

Faecaloma¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Gastrointestinal hypomotility¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Gastrointestinal motility disorder¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Gastrointestinal oedema¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Ileus¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Ileus paralytic¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Intestinal dilatation¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Lip haemorrhage¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Melaena¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

2/85 (2.35%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

3/83 (3.61%)

4/16 (25.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Oesophagopleural fistula¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Oral mucosa haematoma¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Pancreatic failure¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Pancreatic necrosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Pancreatitis¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Perianal erythema¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Gastrointestinal disorders

Rectal haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Gastrointestinal disorders

Salivary hypersecretion¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

2/85 (2.35%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

3/83 (3.61%)

2/16 (12.50%)

4/85 (4.71%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Catheter site inflammation¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Catheter site pain¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Chills¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Complication associated with device¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

General disorders and administration site conditions

Generalised oedema¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Granuloma¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Hyperthermia¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

2/85 (2.35%)

# events

General disorders and administration site conditions

Hypothermia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

General disorders and administration site conditions

Localised oedema¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Medical device pain¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Medical device site dermatitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Medical device site haemorrhage¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Mucosal ulceration¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

4/83 (4.82%)

1/16 (6.25%)

3/85 (3.53%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

8/83 (9.64%)

0/16 (0.00%)

7/85 (8.24%)

# events

General disorders and administration site conditions

Peripheral swelling¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

13/83 (15.66%)

1/16 (6.25%)

16/85 (18.82%)

# events

General disorders and administration site conditions

Swelling¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

General disorders and administration site conditions

Thirst¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Hepatobiliary disorders

Cholelithiasis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Hepatobiliary disorders

Cholestasis¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Hepatobiliary disorders

Drug-induced liver injury¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Hepatobiliary disorders

Hepatocellular injury¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Hepatobiliary disorders

Ischaemic hepatitis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Abdominal infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Acinetobacter infection¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

5/85 (5.88%)

# events

Infections and infestations

Anal fungal infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Bacteraemia¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

4/85 (4.71%)

# events

Infections and infestations

Bacterial abdominal infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Bacterial disease carrier¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

3/85 (3.53%)

# events

Infections and infestations

Bacterial infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Bacterial sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

4/85 (4.71%)

# events

Infections and infestations

Bacteriuria¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Bronchitis bacterial¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Candida infection¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Candiduria¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Citrobacter bacteraemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Clostridium difficile colitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

0/85 (0.00%)

# events

Infections and infestations

Cystitis klebsiella¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Empyema¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Endocarditis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Enterobacter bacteraemia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Enterobacter pneumonia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Enterococcal bacteraemia¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

2/85 (2.35%)

# events

Infections and infestations

Enterococcal infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Enterococcal sepsis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Escherichia bacteraemia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Escherichia urinary tract infection¹,^†

# participants affected / at risk

5/83 (6.02%)

1/16 (6.25%)

3/85 (3.53%)

# events

Infections and infestations

Eye infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Fungaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Fungal skin infection¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Genital infection female¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Infections and infestations

Haematoma infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Herpes virus infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Infectious pleural effusion¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Klebsiella bacteraemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

3/85 (3.53%)

# events

Infections and infestations

Klebsiella infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Klebsiella sepsis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Lower respiratory tract infection bacterial¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Lung infection pseudomonal¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Morganella infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Oral candidiasis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

3/85 (3.53%)

# events

Infections and infestations

Oral fungal infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Oropharyngeal candidiasis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

3/85 (3.53%)

# events

Infections and infestations

Pneumonia acinetobacter¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Pneumonia bacterial¹,^†

# participants affected / at risk

12/83 (14.46%)

2/16 (12.50%)

4/85 (4.71%)

# events

Infections and infestations

Pneumonia escherichia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Pneumonia proteus¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Pneumonia pseudomonal¹,^†

# participants affected / at risk

12/83 (14.46%)

1/16 (6.25%)

13/85 (15.29%)

# events

Infections and infestations

Pneumonia staphylococcal¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Proteus infection¹,^†

# participants affected / at risk

4/83 (4.82%)

1/16 (6.25%)

1/85 (1.18%)

# events

Infections and infestations

Pseudomonal bacteraemia¹,^†

# participants affected / at risk

6/83 (7.23%)

0/16 (0.00%)

6/85 (7.06%)

# events

Infections and infestations

Pseudomonal sepsis¹,^†

# participants affected / at risk

5/83 (6.02%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Pseudomonas bronchitis¹,^†

# participants affected / at risk

5/83 (6.02%)

4/16 (25.00%)

4/85 (4.71%)

# events

Infections and infestations

Pseudomonas infection¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

4/85 (4.71%)

# events

Infections and infestations

Pyuria¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Serratia bacteraemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Serratia sepsis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Staphylococcal bacteraemia¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

4/85 (4.71%)

# events

Infections and infestations

Staphylococcal infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Staphylococcal sepsis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Stenotrophomonas infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Stoma site infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Systemic candida¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Tracheobronchitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

3/85 (3.53%)

# events

Infections and infestations

Urinary tract infection bacterial¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

3/85 (3.53%)

# events

Infections and infestations

Urinary tract infection pseudomonal¹,^†

# participants affected / at risk

5/83 (6.02%)

0/16 (0.00%)

4/85 (4.71%)

# events

Infections and infestations

Urinary tract infection staphylococcal¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Varicella zoster virus infection¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Infections and infestations

Vulvovaginal candidiasis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Infections and infestations

Vulvovaginal mycotic infection¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Dialysis related complication¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Endotracheal intubation complication¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Eschar¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Flail chest¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Gastrostomy tube site complication¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Haemodilution¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Inflammation of wound¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Infusion related reaction¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Injury, poisoning and procedural complications

Joint dislocation¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Overdose¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Palate injury¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Post procedural haematuria¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Post procedural inflammation¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Postoperative hypotension¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Postoperative wound complication¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Procedural haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Procedural hypotension¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Procedural pain¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

3/85 (3.53%)

# events

Injury, poisoning and procedural complications

Scar¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Scratch¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Seroma¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Skin laceration¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Injury, poisoning and procedural complications

Stoma site erythema¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Tracheal haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Vascular pseudoaneurysm¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Weaning failure¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Injury, poisoning and procedural complications

Wound necrosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Injury, poisoning and procedural complications

Wound secretion¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Blood albumin decreased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Blood glucose increased¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Blood magnesium decreased¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Investigations

Blood potassium decreased¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Blood sodium decreased¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Blood urea increased¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

3/85 (3.53%)

# events

Investigations

C-reactive protein increased¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Investigations

Electrocardiogram qt prolonged¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

1/85 (1.18%)

# events

Investigations

Inflammatory marker increased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Oxygen saturation abnormal¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Oxygen saturation decreased¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

3/85 (3.53%)

# events

Investigations

Pco2 increased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

Po2 decreased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Investigations

Transaminases increased¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

1/85 (1.18%)

# events

Investigations

Urine output decreased¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Acidosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Metabolism and nutrition disorders

Alkalosis¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Fluid overload¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Fluid retention¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Metabolism and nutrition disorders

Hyperammonaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Hypercalcaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Metabolism and nutrition disorders

Hypercholesterolaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

4/85 (4.71%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

3/85 (3.53%)

# events

Metabolism and nutrition disorders

Hypernatraemia¹,^†

# participants affected / at risk

3/83 (3.61%)

1/16 (6.25%)

5/85 (5.88%)

# events

Metabolism and nutrition disorders

Hyperphosphataemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Metabolism and nutrition disorders

Hypoalbuminaemia¹,^†

# participants affected / at risk

4/83 (4.82%)

0/16 (0.00%)

3/85 (3.53%)

# events

Metabolism and nutrition disorders

Hypocalcaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

2/85 (2.35%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

9/83 (10.84%)

1/16 (6.25%)

15/85 (17.65%)

# events

Metabolism and nutrition disorders

Hypomagnesaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

3/85 (3.53%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

2/85 (2.35%)

# events

Metabolism and nutrition disorders

Hypophosphataemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

4/85 (4.71%)

# events

Metabolism and nutrition disorders

Hypoproteinaemia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Metabolism and nutrition disorders

Hypovolaemia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Metabolism and nutrition disorders

Metabolic acidosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Metabolism and nutrition disorders

Metabolic alkalosis¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

4/85 (4.71%)

# events

Metabolism and nutrition disorders

Vitamin k deficiency¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

2/85 (2.35%)

# events

Musculoskeletal and connective tissue disorders

Bone disorder¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Musculoskeletal and connective tissue disorders

Coccydynia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Exposed bone in jaw¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

3/83 (3.61%)

3/16 (18.75%)

2/85 (2.35%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal stiffness¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Myopathy¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

3/83 (3.61%)

1/16 (6.25%)

3/85 (3.53%)

# events

Nervous system disorders

Aphasia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Complex regional pain syndrome¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Epilepsy¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Extrapyramidal disorder¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Frontotemporal dementia¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

4/85 (4.71%)

# events

Nervous system disorders

Hydrocephalus¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Hypoxic-ischaemic encephalopathy¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Nervous system disorders

Loss of consciousness¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Metabolic encephalopathy¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Motor dysfunction¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Myoclonus¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Neuropathy peripheral¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Paresis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Parkinsonism¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Peripheral motor neuropathy¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Peripheral sensorimotor neuropathy¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Peroneal nerve palsy¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Nervous system disorders

Post cardiac arrest syndrome¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Psychomotor hyperactivity¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Seizure¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Nervous system disorders

Somnolence¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

2/85 (2.35%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Nervous system disorders

Tremor¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Product issues

Stent malfunction¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Product issues

Thrombosis in device¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Psychiatric disorders

Adjustment disorder with depressed mood¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Psychiatric disorders

Agitation¹,^†

# participants affected / at risk

3/83 (3.61%)

1/16 (6.25%)

3/85 (3.53%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

4/83 (4.82%)

3/16 (18.75%)

2/85 (2.35%)

# events

Psychiatric disorders

Apathy¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Psychiatric disorders

Compulsive lip biting¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Psychiatric disorders

Delirium¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

5/85 (5.88%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

3/85 (3.53%)

# events

Psychiatric disorders

Depressive symptom¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Psychiatric disorders

Disinhibition¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Psychiatric disorders

Disorientation¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

1/85 (1.18%)

# events

Psychiatric disorders

Initial insomnia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

9/83 (10.84%)

0/16 (0.00%)

7/85 (8.24%)

# events

Psychiatric disorders

Intensive care unit delirium¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Psychiatric disorders

Nervousness¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Psychiatric disorders

Restlessness¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Anuria¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Chronic kidney disease¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Renal and urinary disorders

Haemorrhage urinary tract¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Nephrolithiasis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Oliguria¹,^†

# participants affected / at risk

5/83 (6.02%)

1/16 (6.25%)

5/85 (5.88%)

# events

Renal and urinary disorders

Polyuria¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Renal cyst¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Renal and urinary disorders

Renal failure¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

5/85 (5.88%)

# events

Renal and urinary disorders

Renal impairment¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

2/85 (2.35%)

# events

Renal and urinary disorders

Tubulointerstitial nephritis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Renal and urinary disorders

Urinary retention¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Urinary tract disorder¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Renal and urinary disorders

Urine abnormality¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Renal and urinary disorders

Vesical fistula¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Reproductive system and breast disorders

Cervical cyst¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Reproductive system and breast disorders

Genital pain¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Reproductive system and breast disorders

Oedema genital¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Reproductive system and breast disorders

Penile discharge¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Reproductive system and breast disorders

Penile oedema¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Reproductive system and breast disorders

Prostatitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Reproductive system and breast disorders

Pruritus genital¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Reproductive system and breast disorders

Vulval disorder¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Apnoea¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Aspiration¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Atelectasis¹,^†

# participants affected / at risk

4/83 (4.82%)

1/16 (6.25%)

4/85 (4.71%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchial haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchial obstruction¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchial secretion retention¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchiectasis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchospasm¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Chylothorax¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Haemothorax¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hiccups¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hypercapnia¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

5/85 (5.88%)

# events

Respiratory, thoracic and mediastinal disorders

Hyperventilation¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Hypopnoea¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoventilation¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Increased bronchial secretion¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Increased viscosity of bronchial secretion¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Laryngeal oedema¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Lung infiltration¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

0/83 (0.00%)

2/16 (12.50%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural disorder¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

2/83 (2.41%)

3/16 (18.75%)

3/85 (3.53%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary fistula¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory acidosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory distress¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory fatigue¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Rhonchi¹,^†

# participants affected / at risk

2/83 (2.41%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sputum retention¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Respiratory, thoracic and mediastinal disorders

Tachypnoea¹,^†

# participants affected / at risk

2/83 (2.41%)

1/16 (6.25%)

3/85 (3.53%)

# events

Respiratory, thoracic and mediastinal disorders

Throat irritation¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

0/85 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Wheezing¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Blister¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Decubitus ulcer¹,^†

# participants affected / at risk

6/83 (7.23%)

0/16 (0.00%)

5/85 (5.88%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Erythema¹,^†

# participants affected / at risk

3/83 (3.61%)

0/16 (0.00%)

2/85 (2.35%)

# events

Skin and subcutaneous tissue disorders

Generalised erythema¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

0/83 (0.00%)

1/16 (6.25%)

3/85 (3.53%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Rash erythematous¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash maculo-papular¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Rash papular¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash pruritic¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Scab¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Skin irritation¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

2/85 (2.35%)

# events

Skin and subcutaneous tissue disorders

Skin ulcer¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin ulcer haemorrhage¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Skin and subcutaneous tissue disorders

Stasis dermatitis¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Subcutaneous emphysema¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Skin and subcutaneous tissue disorders

Swelling face¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Artery dissection¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Extremity necrosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Haemodynamic instability¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

7/83 (8.43%)

3/16 (18.75%)

3/85 (3.53%)

# events

Vascular disorders

Hypoperfusion¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

16/83 (19.28%)

1/16 (6.25%)

23/85 (27.06%)

# events

Vascular disorders

Jugular vein thrombosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Vascular disorders

Orthostatic hypotension¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Vascular disorders

Peripheral coldness¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Vascular disorders

Phlebitis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Subclavian vein thrombosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Thrombosis¹,^†

# participants affected / at risk

1/83 (1.20%)

0/16 (0.00%)

0/85 (0.00%)

# events

Vascular disorders

Vein disorder¹,^†

# participants affected / at risk

1/83 (1.20%)

1/16 (6.25%)

0/85 (0.00%)

# events

Vascular disorders

Vena cava thrombosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

Vascular disorders

Venous thrombosis¹,^†

# participants affected / at risk

0/83 (0.00%)

0/16 (0.00%)

1/85 (1.18%)

# events

†	Events were collected by systematic assessment
1	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 ongoing 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:	Mark Esser
Organization:	MedImmune, LLC
Phone	+1 301 3986849
E-mail:	[email protected]

Documents available

Redacted CSP for CT.gov results
Download
D5470C00004 Redacted SAP for CT.gov results
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

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

Redacted CSP for CT.gov results

D5470C00004 Redacted SAP for CT.gov results

Trial Results Summaries