Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Study identifier:D8480C00030

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo following 12 Weeks of Treatment in Patients with Metastatic or Recurrent Renal Cell Carcinoma who have had no Previous Anti-VEGF Therapy.

Medical condition

Renal Cell Carcinoma

Phase

Phase 2

Healthy volunteers

Study drug

Cediranib, Cediranib Placebo

Sex

All

Actual Enrollment

105

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Jan 2007

Primary Completion Date: 01 Mar 2008

Study Completion Date: 01 Oct 2016

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Northwood, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Research Site

NIJMEGEN, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Research Site

LEIDEN, Netherlands

Arms	Assigned Interventions
Placebo Comparator: 1 Cediranib placebo	Drug: Cediranib Placebo oral tablet
Experimental: 2 Cediranib	Drug: Cediranib 45 mg oral tablet Other Name: AZD2171 Other Name: RECENTIN™

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-one patients were randomised to study treatment: 53 to cediranib 45 mg and 18 to placebo. Following unblinding for the primary analysis, all patients, except those who had progressed on cediranib, then had the option of receiving open-label treatment with cediranib. Randomised=ITT=Safety set: Cediranib 45mg 53, Placebo 18.

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
AZD2171 45 mg	AZD2171 45mg/Day: 53 patients randomised
Placebo	Placebo / Day: 18 patients randomised

Participant Flow: Overall Study

	AZD2171 45 mg	Placebo
STARTED	53^[1]	18^[2]
Continuing after unblinding	44^[3]	14^[4]
Ongoing at data cut off (8th March 2009)	22^[5]	4^[6]
COMPLETED	44^[7]	11^[8]
NOT COMPLETED	9	7
Adverse Event	6	2
Withdrawal by Subject	1	0
Condition under investigation worsened	1	1
Progressive at Week 6	0	1
Unblinded before 12 weeks	1	3

[1]	Randomised
[2]	Number randomised
[3]	Number starting/ continuing AZD2171 after unblinding
[4]	Number starting/ continuing AZD2171 after unblinding
[5]	Number ongoing at data cut off (8th March 2009)
[6]	Number ongoing at data cut off (8th March 2009)
[7]	Number completing 12 weeks blinded randomised treatment
[8]	Number completing 12 weeks blinded randomised treatment

Baseline Characteristics

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

Reporting Groups

	Description
AZD2171 45 mg	AZD2171 45mg/Day
Placebo	Placebo/Day

Baseline Measures

	AZD2171 45 mg	Placebo	Total
Number of Participants [units: Participants]	53	18	71
Age Continuous ^[1] [units: Years] Mean ± Standard Deviation
Gender, Male/Female ^[2] [units: ]
Female	13	3	16
Male	40	15	55

Outcome Measures

1. Primary Outcome Measure: Percentage change from baseline in tumour size at 12 weeks [ Time Frame: Baseline to Week 12 ]

Measure Type	Primary
Measure Name	Percentage change from baseline in tumour size at 12 weeks
Measure Description	Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100
Time Frame	Baseline to Week 12
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

2. Secondary Outcome Measure: Best percentage change from baseline in tumour size during the study [ Time Frame: Treatment period up to Week 12 visit date for last patient in (LPI) ]

Measure Type	Secondary
Measure Name	Best percentage change from baseline in tumour size during the study
Measure Description	Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
Time Frame	Treatment period up to Week 12 visit date for last patient in (LPI)
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

3. Secondary Outcome Measure: Duration of response [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009 ]

Measure Type	Secondary
Measure Name	Duration of response
Measure Description	Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.
Time Frame	Treatment period up to 2nd data cut-off of 8th March 2009
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

4. Secondary Outcome Measure: Progression free survival [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009. ]

Measure Type	Secondary
Measure Name	Progression free survival
Measure Description	Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Time Frame	Treatment period up to 2nd data cut-off of 8th March 2009.
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

5. Secondary Outcome Measure: Objective tumour response at 12 weeks [ Time Frame: Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12. ]

Measure Type	Secondary
Measure Name	Objective tumour response at 12 weeks
Measure Description	Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.
Time Frame	Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

6. Secondary Outcome Measure: Best objective tumour response [ Time Frame: Baseline, Week 12 and every 8 weeks thereafter or until progression. ]

Measure Type	Secondary
Measure Name	Best objective tumour response
Measure Description	Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).
Time Frame	Baseline, Week 12 and every 8 weeks thereafter or until progression.
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
cediranib DB	Double Blind part
placebo DB	Double Blind part
cediranib OL	Open Label part

Serious Adverse Events

cediranib DB

placebo DB

cediranib OL

Total, serious adverse events

# participants affected / at risk

10/53 (18.87%)

3/18 (16.67%)

15/58 (25.86%)

Cardiac disorders

Atrial Fibrillation¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Gastrointestinal disorders

Abdominal Pain¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

2/58 (3.45%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

2/58 (3.45%)

Gastrointestinal disorders

Abdominal Pain Upper¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Gastrointestinal disorders

Gastric Ulcer Haemorrhage¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Gastrointestinal disorders

Gastrointestinal Haemorrhage¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

1/58 (1.72%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

1/58 (1.72%)

General disorders

Fatigue¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Hepatobiliary disorders

Hepatic Function Abnormal¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Hepatobiliary disorders

Jaundice Cholestatic¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Infections and infestations

Lower Respiratory Tract Infection¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Infections and infestations

Urinary Tract Infection¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Injury, poisoning and procedural complications

Clavicle Fracture¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Injury, poisoning and procedural complications

Lower Limb Fracture¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Investigations

Blood Calcium Increased¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

2/58 (3.45%)

Metabolism and nutrition disorders

Hypercalcaemia¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Musculoskeletal and connective tissue disorders

Bursitis¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Musculoskeletal and connective tissue disorders

Muscular Weakness¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Chest Pain¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

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

Intracranial Tumour Haemorrhage¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Nervous system disorders

Cerebral Infarction¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Nervous system disorders

Coma¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Nervous system disorders

Loss Of Consciousness¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Nervous system disorders

Reversible Posterior Leukoencephalopathy Syndrome¹,^†

# participants affected / at risk

1/53 (1.89%)

1/18 (5.56%)

1/58 (1.72%)

Psychiatric disorders

Agitation¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Psychiatric disorders

Confusional State¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Renal and urinary disorders

Renal Failure Acute¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Reproductive system and breast disorders

Bartholin's Cyst¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

2/58 (3.45%)

Respiratory, thoracic and mediastinal disorders

Pulmonary Embolism¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Skin and subcutaneous tissue disorders

Dermatitis Bullous¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

0/58 (0.00%)

Vascular disorders

Orthostatic Hypotension¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

1/58 (1.72%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
cediranib DB	Double Blind part
placebo DB	Double Blind part
cediranib OL	Open Label part

Other Adverse Events

cediranib DB

placebo DB

cediranib OL

Total, other (not including serious) adverse events

# participants affected / at risk

53/53 (100.00%)

16/18 (88.89%)

57/58 (98.28%)

Cardiac disorders

Splinter Haemorrhages¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

1/58 (1.72%)

Ear and labyrinth disorders

Tinnitus¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

2/58 (3.45%)

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

39/53 (73.58%)

5/18 (27.78%)

35/58 (60.34%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

17/53 (32.08%)

5/18 (27.78%)

26/58 (44.83%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

16/53 (30.19%)

4/18 (22.22%)

10/58 (17.24%)

Gastrointestinal disorders

Stomatitis¹,^†

# participants affected / at risk

16/53 (30.19%)

2/18 (11.11%)

13/58 (22.41%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

9/53 (16.98%)

4/18 (22.22%)

13/58 (22.41%)

Gastrointestinal disorders

Abdominal Pain¹,^†

# participants affected / at risk

7/53 (13.21%)

2/18 (11.11%)

9/58 (15.52%)

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

5/53 (9.43%)

3/18 (16.67%)

7/58 (12.07%)

Gastrointestinal disorders

Abdominal Pain Upper¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Dry Mouth¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Glossodynia¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

0/58 (0.00%)

Gastrointestinal disorders

Haemorrhoids¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Oral Pain¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

3/58 (5.17%)

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

2/58 (3.45%)

Gastrointestinal disorders

Abdominal Distension¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

1/58 (1.72%)

Gastrointestinal disorders

Gastrooesophageal Reflux Disease¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

General disorders

Fatigue¹,^†

# participants affected / at risk

31/53 (58.49%)

9/18 (50.00%)

25/58 (43.10%)

General disorders

Feeling Cold¹,^†

# participants affected / at risk

5/53 (9.43%)

0/18 (0.00%)

0/58 (0.00%)

General disorders

Oedema Peripheral¹,^†

# participants affected / at risk

5/53 (9.43%)

2/18 (11.11%)

4/58 (6.90%)

General disorders

Chills¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

1/58 (1.72%)

General disorders

Non-Cardiac Chest Pain¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

3/58 (5.17%)

General disorders

Pyrexia¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

2/58 (3.45%)

Hepatobiliary disorders

Jaundice¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

4/53 (7.55%)

1/18 (5.56%)

11/58 (18.97%)

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

2/53 (3.77%)

0/18 (0.00%)

5/58 (8.62%)

Infections and infestations

Lower Respiratory Tract Infection¹,^†

# participants affected / at risk

4/53 (7.55%)

2/18 (11.11%)

4/58 (6.90%)

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

3/58 (5.17%)

Infections and infestations

Urinary Tract Infection¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

3/58 (5.17%)

Infections and infestations

Oral Candidiasis¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

2/58 (3.45%)

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

1/58 (1.72%)

Infections and infestations

Oral Herpes¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

1/58 (1.72%)

Injury, poisoning and procedural complications

Arthropod Bite¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Injury, poisoning and procedural complications

Procedural Pain¹,^†

# participants affected / at risk

1/53 (1.89%)

1/18 (5.56%)

1/58 (1.72%)

Injury, poisoning and procedural complications

Sunburn¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Investigations

Weight Decreased¹,^†

# participants affected / at risk

6/53 (11.32%)

1/18 (5.56%)

15/58 (25.86%)

Metabolism and nutrition disorders

Anorexia¹,^†

# participants affected / at risk

13/53 (24.53%)

0/18 (0.00%)

11/58 (18.97%)

Metabolism and nutrition disorders

Decreased Appetite¹,^†

# participants affected / at risk

9/53 (16.98%)

0/18 (0.00%)

11/58 (18.97%)

Metabolism and nutrition disorders

Appetite Disorder¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Musculoskeletal and connective tissue disorders

Back Pain¹,^†

# participants affected / at risk

6/53 (11.32%)

4/18 (22.22%)

8/58 (13.79%)

Musculoskeletal and connective tissue disorders

Pain In Extremity¹,^†

# participants affected / at risk

3/53 (5.66%)

1/18 (5.56%)

8/58 (13.79%)

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

6/53 (11.32%)

0/18 (0.00%)

4/58 (6.90%)

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

5/53 (9.43%)

2/18 (11.11%)

4/58 (6.90%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Pain¹,^†

# participants affected / at risk

5/53 (9.43%)

1/18 (5.56%)

4/58 (6.90%)

Musculoskeletal and connective tissue disorders

Muscle Spasms¹,^†

# participants affected / at risk

4/53 (7.55%)

1/18 (5.56%)

4/58 (6.90%)

Musculoskeletal and connective tissue disorders

Muscular Weakness¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

2/58 (3.45%)

Musculoskeletal and connective tissue disorders

Bone Pain¹,^†

# participants affected / at risk

2/53 (3.77%)

0/18 (0.00%)

3/58 (5.17%)

Musculoskeletal and connective tissue disorders

Flank Pain¹,^†

# participants affected / at risk

0/53 (0.00%)

3/18 (16.67%)

3/58 (5.17%)

Musculoskeletal and connective tissue disorders

Joint Stiffness¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

2/58 (3.45%)

Musculoskeletal and connective tissue disorders

Joint Swelling¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

1/58 (1.72%)

Musculoskeletal and connective tissue disorders

Musculoskeletal Stiffness¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

3/58 (5.17%)

Musculoskeletal and connective tissue disorders

Neck Pain¹,^†

# participants affected / at risk

3/53 (5.66%)

1/18 (5.56%)

2/58 (3.45%)

Musculoskeletal and connective tissue disorders

Groin Pain¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

1/58 (1.72%)

Musculoskeletal and connective tissue disorders

Myopathy¹,^†

# participants affected / at risk

1/53 (1.89%)

1/18 (5.56%)

0/58 (0.00%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

24/53 (45.28%)

4/18 (22.22%)

10/58 (17.24%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

8/53 (15.09%)

0/18 (0.00%)

6/58 (10.34%)

Nervous system disorders

Lethargy¹,^†

# participants affected / at risk

7/53 (13.21%)

1/18 (5.56%)

2/58 (3.45%)

Nervous system disorders

Dysgeusia¹,^†

# participants affected / at risk

5/53 (9.43%)

0/18 (0.00%)

4/58 (6.90%)

Nervous system disorders

Paraesthesia¹,^†

# participants affected / at risk

1/53 (1.89%)

1/18 (5.56%)

4/58 (6.90%)

Nervous system disorders

Dyskinesia¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Nervous system disorders

Somnolence¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

6/53 (11.32%)

0/18 (0.00%)

4/58 (6.90%)

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

5/58 (8.62%)

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

2/53 (3.77%)

1/18 (5.56%)

0/58 (0.00%)

Psychiatric disorders

Confusional State¹,^†

# participants affected / at risk

2/53 (3.77%)

1/18 (5.56%)

2/58 (3.45%)

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

1/58 (1.72%)

Renal and urinary disorders

Dysuria¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Renal and urinary disorders

Renal Failure¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Respiratory, thoracic and mediastinal disorders

Dysphonia¹,^†

# participants affected / at risk

31/53 (58.49%)

1/18 (5.56%)

18/58 (31.03%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

7/53 (13.21%)

2/18 (11.11%)

10/58 (17.24%)

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

4/53 (7.55%)

3/18 (16.67%)

6/58 (10.34%)

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

3/58 (5.17%)

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

1/58 (1.72%)

Respiratory, thoracic and mediastinal disorders

Rales¹,^†

# participants affected / at risk

2/53 (3.77%)

3/18 (16.67%)

2/58 (3.45%)

Respiratory, thoracic and mediastinal disorders

Oropharyngeal Pain¹,^†

# participants affected / at risk

2/53 (3.77%)

2/18 (11.11%)

2/58 (3.45%)

Respiratory, thoracic and mediastinal disorders

Productive Cough¹,^†

# participants affected / at risk

1/53 (1.89%)

1/18 (5.56%)

2/58 (3.45%)

Skin and subcutaneous tissue disorders

Palmar-Plantar Erythrodysaesthesia Syndrome¹,^†

# participants affected / at risk

11/53 (20.75%)

0/18 (0.00%)

12/58 (20.69%)

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

10/53 (18.87%)

2/18 (11.11%)

8/58 (13.79%)

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

3/53 (5.66%)

1/18 (5.56%)

7/58 (12.07%)

Skin and subcutaneous tissue disorders

Dry Skin¹,^†

# participants affected / at risk

4/53 (7.55%)

0/18 (0.00%)

2/58 (3.45%)

Skin and subcutaneous tissue disorders

Erythema¹,^†

# participants affected / at risk

1/53 (1.89%)

0/18 (0.00%)

4/58 (6.90%)

Skin and subcutaneous tissue disorders

Hyperkeratosis¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

3/58 (5.17%)

Skin and subcutaneous tissue disorders

Rash Erythematous¹,^†

# participants affected / at risk

3/53 (5.66%)

0/18 (0.00%)

0/58 (0.00%)

Skin and subcutaneous tissue disorders

Rash Macular¹,^†

# participants affected / at risk

1/53 (1.89%)

2/18 (11.11%)

3/58 (5.17%)

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

2/53 (3.77%)

1/18 (5.56%)

1/58 (1.72%)

Skin and subcutaneous tissue disorders

Actinic Keratosis¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Skin and subcutaneous tissue disorders

Cold Sweat¹,^†

# participants affected / at risk

0/53 (0.00%)

1/18 (5.56%)

0/58 (0.00%)

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

34/53 (64.15%)

4/18 (22.22%)

7/58 (12.07%)

Vascular disorders

Flushing¹,^†

# participants affected / at risk

3/53 (5.66%)

1/18 (5.56%)

1/58 (1.72%)

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/53 (0.00%)

0/18 (0.00%)

3/58 (5.17%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.1
2	Term from vocabulary,

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: If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.

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
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

CSR-D8480C00030.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Jane Robertson

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR-D8480C00030.pdf

Trial Results Summaries