Trial Outcomes & Findings for Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma (NCT NCT00423332)
NCT ID: NCT00423332
Last Updated: 2017-02-02
Results Overview
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
COMPLETED
PHASE2
105 participants
Baseline to Week 12
2017-02-02
Participant Flow
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.
Participant milestones
| Measure |
AZD2171 45 mg
AZD2171 45mg/Day: 53 patients randomised
|
Placebo
Placebo / Day: 18 patients randomised
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
18
|
|
Overall Study
Continuing After Unblinding
|
44
|
14
|
|
Overall Study
Ongoing at Data Cut Off (8th March 2009)
|
22
|
4
|
|
Overall Study
COMPLETED
|
44
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
AZD2171 45 mg
AZD2171 45mg/Day: 53 patients randomised
|
Placebo
Placebo / Day: 18 patients randomised
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Condition under investigation worsened
|
1
|
1
|
|
Overall Study
Progressive at Week 6
|
0
|
1
|
|
Overall Study
Unblinded before 12 weeks
|
1
|
3
|
Baseline Characteristics
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
AZD2171 45 mg
n=53 Participants
AZD2171 45mg/Day
|
Placebo
n=18 Participants
Placebo/Day
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
40 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
Outcome measures
| Measure |
AZD2171 45 mg
n=51 Participants
AZD2171 45mg/Day
|
Placebo
n=17 Participants
Placebo/Day
|
|---|---|---|
|
Percentage Change From Baseline in Tumour Size at 12 Weeks
|
-19.47 Percentage change from baseline
Standard Deviation 17.093
|
19.65 Percentage change from baseline
Standard Deviation 22.902
|
SECONDARY outcome
Timeframe: Treatment period up to Week 12 visit date for last patient in (LPI)Population: For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.
Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
Outcome measures
| Measure |
AZD2171 45 mg
n=51 Participants
AZD2171 45mg/Day
|
Placebo
n=17 Participants
Placebo/Day
|
|---|---|---|
|
Best Percentage Change From Baseline in Tumour Size During the Study
|
-26.90 Percentage change from baseline
Standard Deviation 23.153
|
1.09 Percentage change from baseline
Standard Deviation 26.783
|
SECONDARY outcome
Timeframe: Treatment period up to 2nd data cut-off of 8th March 2009Population: For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)). 13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off.
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.
Outcome measures
| Measure |
AZD2171 45 mg
n=18 Participants
AZD2171 45mg/Day
|
Placebo
n=1 Participants
Placebo/Day
|
|---|---|---|
|
Duration of Response
|
18.595 Months
Interval 12.517 to 18.595
|
11.1 Months
Interval 11.1 to 11.1
|
SECONDARY outcome
Timeframe: Treatment period up to 2nd data cut-off of 8th March 2009.Population: Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.
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.
Outcome measures
| Measure |
AZD2171 45 mg
n=53 Participants
AZD2171 45mg/Day
|
Placebo
n=18 Participants
Placebo/Day
|
|---|---|---|
|
Progression Free Survival
|
12.1 Months
Interval 0.0 to 21.6
|
2.76 Months
Interval 0.0 to 21.5
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
AZD2171 45 mg
n=53 Participants
AZD2171 45mg/Day
|
Placebo
n=18 Participants
Placebo/Day
|
|---|---|---|
|
Objective Tumour Response at 12 Weeks
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and every 8 weeks thereafter or until progression.Population: For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a 'best response' summary.
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).
Outcome measures
| Measure |
AZD2171 45 mg
n=53 Participants
AZD2171 45mg/Day
|
Placebo
n=18 Participants
Placebo/Day
|
|---|---|---|
|
Best Objective Tumour Response
|
18 Participants
|
1 Participants
|
Adverse Events
Cediranib DB
Placebo DB
Cediranib OL
Serious adverse events
| Measure |
Cediranib DB
n=53 participants at risk
Double Blind part
|
Placebo DB
n=18 participants at risk
Double Blind part
|
Cediranib OL
n=58 participants at risk
Open Label part
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53
|
0.00%
0/18
|
1.7%
1/58
|
|
General disorders
Fatigue
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Investigations
Blood Calcium Increased
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial Tumour Haemorrhage
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Nervous system disorders
Coma
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Nervous system disorders
Headache
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Nervous system disorders
Loss Of Consciousness
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
1.9%
1/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Psychiatric disorders
Agitation
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Bartholin's Cyst
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Vascular disorders
Hypertension
|
1.9%
1/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/53
|
0.00%
0/18
|
1.7%
1/58
|
Other adverse events
| Measure |
Cediranib DB
n=53 participants at risk
Double Blind part
|
Placebo DB
n=18 participants at risk
Double Blind part
|
Cediranib OL
n=58 participants at risk
Open Label part
|
|---|---|---|---|
|
Cardiac disorders
Splinter Haemorrhages
|
5.7%
3/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Ear and labyrinth disorders
Tinnitus
|
5.7%
3/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Endocrine disorders
Hypothyroidism
|
7.5%
4/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Diarrhoea
|
73.6%
39/53
|
27.8%
5/18
|
60.3%
35/58
|
|
Gastrointestinal disorders
Nausea
|
32.1%
17/53
|
27.8%
5/18
|
44.8%
26/58
|
|
Gastrointestinal disorders
Constipation
|
30.2%
16/53
|
22.2%
4/18
|
17.2%
10/58
|
|
Gastrointestinal disorders
Stomatitis
|
30.2%
16/53
|
11.1%
2/18
|
22.4%
13/58
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
9/53
|
22.2%
4/18
|
22.4%
13/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.2%
7/53
|
11.1%
2/18
|
15.5%
9/58
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
5/53
|
16.7%
3/18
|
12.1%
7/58
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.5%
4/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Dry Mouth
|
5.7%
3/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Glossodynia
|
5.7%
3/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
1/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Oral Pain
|
5.7%
3/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Gastrointestinal disorders
Toothache
|
5.7%
3/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
General disorders
Fatigue
|
58.5%
31/53
|
50.0%
9/18
|
43.1%
25/58
|
|
General disorders
Feeling Cold
|
9.4%
5/53
|
0.00%
0/18
|
0.00%
0/58
|
|
General disorders
Oedema Peripheral
|
9.4%
5/53
|
11.1%
2/18
|
6.9%
4/58
|
|
General disorders
Chills
|
5.7%
3/53
|
0.00%
0/18
|
1.7%
1/58
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/53
|
0.00%
0/18
|
5.2%
3/58
|
|
General disorders
Pyrexia
|
0.00%
0/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
4/53
|
5.6%
1/18
|
19.0%
11/58
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.8%
2/53
|
0.00%
0/18
|
8.6%
5/58
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
7.5%
4/53
|
11.1%
2/18
|
6.9%
4/58
|
|
Infections and infestations
Sinusitis
|
0.00%
0/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Infections and infestations
Influenza
|
0.00%
0/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.9%
1/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Investigations
Weight Decreased
|
11.3%
6/53
|
5.6%
1/18
|
25.9%
15/58
|
|
Metabolism and nutrition disorders
Anorexia
|
24.5%
13/53
|
0.00%
0/18
|
19.0%
11/58
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.0%
9/53
|
0.00%
0/18
|
19.0%
11/58
|
|
Metabolism and nutrition disorders
Appetite Disorder
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.3%
6/53
|
22.2%
4/18
|
13.8%
8/58
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.7%
3/53
|
5.6%
1/18
|
13.8%
8/58
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.3%
6/53
|
0.00%
0/18
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
5/53
|
11.1%
2/18
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.4%
5/53
|
5.6%
1/18
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.5%
4/53
|
5.6%
1/18
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.5%
4/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
2/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/53
|
16.7%
3/18
|
5.2%
3/58
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
5.7%
3/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
5.7%
3/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
5.7%
3/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.7%
3/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.9%
1/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Nervous system disorders
Headache
|
45.3%
24/53
|
22.2%
4/18
|
17.2%
10/58
|
|
Nervous system disorders
Dizziness
|
15.1%
8/53
|
0.00%
0/18
|
10.3%
6/58
|
|
Nervous system disorders
Lethargy
|
13.2%
7/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Nervous system disorders
Dysgeusia
|
9.4%
5/53
|
0.00%
0/18
|
6.9%
4/58
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/53
|
5.6%
1/18
|
6.9%
4/58
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Psychiatric disorders
Insomnia
|
11.3%
6/53
|
0.00%
0/18
|
6.9%
4/58
|
|
Psychiatric disorders
Depression
|
1.9%
1/53
|
0.00%
0/18
|
8.6%
5/58
|
|
Psychiatric disorders
Anxiety
|
3.8%
2/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Psychiatric disorders
Confusional State
|
3.8%
2/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Renal and urinary disorders
Proteinuria
|
7.5%
4/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
58.5%
31/53
|
5.6%
1/18
|
31.0%
18/58
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.2%
7/53
|
11.1%
2/18
|
17.2%
10/58
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
4/53
|
16.7%
3/18
|
10.3%
6/58
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
4/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.5%
4/53
|
0.00%
0/18
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
3.8%
2/53
|
16.7%
3/18
|
3.4%
2/58
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.8%
2/53
|
11.1%
2/18
|
3.4%
2/58
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.9%
1/53
|
5.6%
1/18
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
20.8%
11/53
|
0.00%
0/18
|
20.7%
12/58
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.9%
10/53
|
11.1%
2/18
|
13.8%
8/58
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
3/53
|
5.6%
1/18
|
12.1%
7/58
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.5%
4/53
|
0.00%
0/18
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/53
|
0.00%
0/18
|
6.9%
4/58
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/53
|
0.00%
0/18
|
5.2%
3/58
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
5.7%
3/53
|
0.00%
0/18
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
1.9%
1/53
|
11.1%
2/18
|
5.2%
3/58
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/53
|
5.6%
1/18
|
0.00%
0/58
|
|
Vascular disorders
Hypertension
|
64.2%
34/53
|
22.2%
4/18
|
12.1%
7/58
|
|
Vascular disorders
Flushing
|
5.7%
3/53
|
5.6%
1/18
|
1.7%
1/58
|
|
Vascular disorders
Hypotension
|
0.00%
0/53
|
0.00%
0/18
|
5.2%
3/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER