Trial Outcomes & Findings for Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours (NCT NCT00264004)
NCT ID: NCT00264004
Last Updated: 2012-08-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
12 week treatment period
Results posted on
2012-08-29
Participant Flow
Participant milestones
| Measure |
AZD2171 30 mg Anti HT
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
30
|
34
|
|
Overall Study
COMPLETED
|
13
|
21
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
14
|
15
|
Reasons for withdrawal
| Measure |
AZD2171 30 mg Anti HT
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
2
|
|
Overall Study
Other
|
2
|
2
|
0
|
3
|
|
Overall Study
Development study specific disc. crit.
|
1
|
0
|
1
|
0
|
|
Overall Study
Cond. under inv. worsened
|
9
|
5
|
3
|
4
|
|
Overall Study
Not treated
|
3
|
0
|
2
|
2
|
Baseline Characteristics
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
AZD2171 30 mg Anti HT
n=30 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=32 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=30 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
Age
|
58.1 Years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
52.7 Years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
56.4 Years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
53.5 Years
STANDARD_DEVIATION 11.7 • n=483 Participants
|
55.175 Years
STANDARD_DEVIATION 11.225 • n=36 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
66 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 week treatment periodOutcome measures
| Measure |
AZD2171 30 mg Anti HT
n=30 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=32 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=30 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
|
12 Participants
|
19 Participants
|
20 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 12 week treatment periodTotal actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)
Outcome measures
| Measure |
AZD2171 30 mg Anti HT
n=30 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=32 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=30 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
|
0.89 Poportion of Planned Dose
Interval 0.62 to 1.0
|
0.88 Poportion of Planned Dose
Interval 0.76 to 0.98
|
0.74 Poportion of Planned Dose
Interval 0.58 to 0.91
|
0.79 Poportion of Planned Dose
Interval 0.64 to 0.87
|
SECONDARY outcome
Timeframe: First 6 weeks of 12 week treatment periodOutcome measures
| Measure |
AZD2171 30 mg Anti HT
n=30 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=32 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=30 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
|
9 Participants
|
9 Participants
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 12 week treatment periodNumber of patients with complete or partial response (CR/PR), based on RECIST
Outcome measures
| Measure |
AZD2171 30 mg Anti HT
n=29 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=32 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=30 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Objective Response Rate
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Randomisation until end of treatment periodMaximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.
Outcome measures
| Measure |
AZD2171 30 mg Anti HT
n=25 Participants
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=29 Participants
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=21 Participants
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=27 Participants
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Best Percentage Change in Tumour Size
|
-1.12 percentage of tumor size
Interval -8.96 to 7.38
|
-10.81 percentage of tumor size
Interval -23.99 to 4.65
|
-11.78 percentage of tumor size
Interval -22.53 to 0.46
|
-13.13 percentage of tumor size
Interval -20.39 to -5.21
|
Adverse Events
AZD2171 30 mg Anti HT
Serious events: 19 serious events
Other events: 31 other events
Deaths: 0 deaths
AZD2171 30 mg No Anti HT
Serious events: 20 serious events
Other events: 34 other events
Deaths: 0 deaths
AZD2171 45 mg Anti HT
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
AZD2171 45 mg No Anti HT
Serious events: 10 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD2171 30 mg Anti HT
n=28 participants at risk
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=31 participants at risk
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=26 participants at risk
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 participants at risk
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
2/28
|
3.2%
1/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28
|
3.2%
1/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28
|
3.2%
1/31
|
7.7%
2/26
|
2.9%
1/34
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28
|
6.5%
2/31
|
3.8%
1/26
|
2.9%
1/34
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/28
|
0.00%
0/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
General disorders
Fatigue
|
3.6%
1/28
|
3.2%
1/31
|
7.7%
2/26
|
5.9%
2/34
|
|
General disorders
Pyrexia
|
7.1%
2/28
|
0.00%
0/31
|
3.8%
1/26
|
2.9%
1/34
|
|
General disorders
Euthanasia
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
General disorders
Malaise
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
General disorders
Non-Cardiac Chest Pain
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Hepatobiliary disorders
Cholestasis
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Erysipelas
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Lung Infection
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Urosepsis
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Blood Bilirubin Increased
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Hepatic Enzyme Increased
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
8.8%
3/34
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/28
|
3.2%
1/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
3.6%
1/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Psychiatric disorders
Confusional State
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Renal and urinary disorders
Renal Impairment
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Renal and urinary disorders
Urethral Pain
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28
|
3.2%
1/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Vascular disorders
Hypertension
|
10.7%
3/28
|
16.1%
5/31
|
15.4%
4/26
|
0.00%
0/34
|
|
Vascular disorders
Hypotension
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Vascular disorders
Venous Thrombosis Limb
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
Other adverse events
| Measure |
AZD2171 30 mg Anti HT
n=28 participants at risk
AZD2171 30 mg AntiHT prophylaxis
|
AZD2171 30 mg No Anti HT
n=31 participants at risk
AZD2171 30 mg No AntiHT prophylaxis
|
AZD2171 45 mg Anti HT
n=26 participants at risk
AZD2171 45 mg AntiHT prophylaxis
|
AZD2171 45 mg No Anti HT
n=34 participants at risk
AZD2171 45 mg No AntiHT prophylaxis
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
4/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28
|
12.9%
4/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Ear and labyrinth disorders
Ear Discomfort
|
7.1%
2/28
|
3.2%
1/31
|
7.7%
2/26
|
2.9%
1/34
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
4/28
|
22.6%
7/31
|
3.8%
1/26
|
11.8%
4/34
|
|
Eye disorders
Vision Blurred
|
7.1%
2/28
|
0.00%
0/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Gastrointestinal disorders
Diarrhoea
|
82.1%
23/28
|
77.4%
24/31
|
88.5%
23/26
|
58.8%
20/34
|
|
Gastrointestinal disorders
Nausea
|
57.1%
16/28
|
48.4%
15/31
|
30.8%
8/26
|
23.5%
8/34
|
|
Gastrointestinal disorders
Stomatitis
|
35.7%
10/28
|
41.9%
13/31
|
26.9%
7/26
|
35.3%
12/34
|
|
Gastrointestinal disorders
Constipation
|
32.1%
9/28
|
25.8%
8/31
|
19.2%
5/26
|
14.7%
5/34
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28
|
25.8%
8/31
|
30.8%
8/26
|
14.7%
5/34
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
2/28
|
22.6%
7/31
|
11.5%
3/26
|
11.8%
4/34
|
|
Gastrointestinal disorders
Dry Mouth
|
10.7%
3/28
|
16.1%
5/31
|
11.5%
3/26
|
17.6%
6/34
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
2/28
|
19.4%
6/31
|
11.5%
3/26
|
5.9%
2/34
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.1%
2/28
|
9.7%
3/31
|
3.8%
1/26
|
11.8%
4/34
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28
|
6.5%
2/31
|
15.4%
4/26
|
5.9%
2/34
|
|
Gastrointestinal disorders
Ascites
|
3.6%
1/28
|
6.5%
2/31
|
11.5%
3/26
|
2.9%
1/34
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28
|
9.7%
3/31
|
11.5%
3/26
|
2.9%
1/34
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
General disorders
Fatigue
|
67.9%
19/28
|
67.7%
21/31
|
73.1%
19/26
|
52.9%
18/34
|
|
General disorders
Pyrexia
|
14.3%
4/28
|
6.5%
2/31
|
11.5%
3/26
|
2.9%
1/34
|
|
General disorders
Asthenia
|
3.6%
1/28
|
9.7%
3/31
|
3.8%
1/26
|
2.9%
1/34
|
|
General disorders
Chills
|
0.00%
0/28
|
3.2%
1/31
|
11.5%
3/26
|
2.9%
1/34
|
|
General disorders
Mucosal Inflammation
|
3.6%
1/28
|
9.7%
3/31
|
0.00%
0/26
|
2.9%
1/34
|
|
General disorders
Oedema Peripheral
|
10.7%
3/28
|
9.7%
3/31
|
7.7%
2/26
|
2.9%
1/34
|
|
General disorders
Chest Discomfort
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
General disorders
Face Oedema
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
General disorders
Influenza Like Illness
|
0.00%
0/28
|
6.5%
2/31
|
7.7%
2/26
|
0.00%
0/34
|
|
General disorders
Non-Cardiac Chest Pain
|
3.6%
1/28
|
6.5%
2/31
|
0.00%
0/26
|
5.9%
2/34
|
|
General disorders
Temperature Intolerance
|
7.1%
2/28
|
3.2%
1/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
7/28
|
3.2%
1/31
|
7.7%
2/26
|
5.9%
2/34
|
|
Infections and infestations
Cystitis
|
3.6%
1/28
|
9.7%
3/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Urinary Tract Infection
|
10.7%
3/28
|
6.5%
2/31
|
3.8%
1/26
|
5.9%
2/34
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Oral Candidiasis
|
3.6%
1/28
|
3.2%
1/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/28
|
3.2%
1/31
|
3.8%
1/26
|
5.9%
2/34
|
|
Infections and infestations
Viral Infection
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Weight Decreased
|
28.6%
8/28
|
16.1%
5/31
|
11.5%
3/26
|
8.8%
3/34
|
|
Infections and infestations
Blood Thyroid Stimulating Hormone Increased
|
7.1%
2/28
|
16.1%
5/31
|
11.5%
3/26
|
5.9%
2/34
|
|
Infections and infestations
Alanine Aminotransferase Increased
|
7.1%
2/28
|
9.7%
3/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Infections and infestations
Aspartate Aminotransferase Increased
|
3.6%
1/28
|
3.2%
1/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Infections and infestations
Blood Alkaline Phosphatase Increased
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Blood Bilirubin Increased
|
7.1%
2/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Blood Creatinine Increased
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Infections and infestations
Gamma-Glutamyltransferase Increased
|
0.00%
0/28
|
6.5%
2/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Infections and infestations
Transaminases Increased
|
3.6%
1/28
|
3.2%
1/31
|
7.7%
2/26
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
14/28
|
38.7%
12/31
|
30.8%
8/26
|
35.3%
12/34
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.6%
1/28
|
9.7%
3/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
5/28
|
9.7%
3/31
|
11.5%
3/26
|
17.6%
6/34
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
2/28
|
16.1%
5/31
|
15.4%
4/26
|
14.7%
5/34
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
17.9%
5/28
|
6.5%
2/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
4/28
|
6.5%
2/31
|
7.7%
2/26
|
8.8%
3/34
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.6%
1/28
|
9.7%
3/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.6%
1/28
|
3.2%
1/31
|
11.5%
3/26
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/28
|
9.7%
3/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
7.1%
2/28
|
16.1%
5/31
|
19.2%
5/26
|
5.9%
2/34
|
|
Nervous system disorders
Headache
|
25.0%
7/28
|
19.4%
6/31
|
7.7%
2/26
|
26.5%
9/34
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28
|
16.1%
5/31
|
7.7%
2/26
|
17.6%
6/34
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.1%
2/28
|
6.5%
2/31
|
11.5%
3/26
|
2.9%
1/34
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28
|
0.00%
0/31
|
7.7%
2/26
|
0.00%
0/34
|
|
Nervous system disorders
Lethargy
|
7.1%
2/28
|
3.2%
1/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Psychiatric disorders
Insomnia
|
17.9%
5/28
|
0.00%
0/31
|
3.8%
1/26
|
5.9%
2/34
|
|
Psychiatric disorders
Depression
|
10.7%
3/28
|
12.9%
4/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
4/28
|
19.4%
6/31
|
0.00%
0/26
|
8.8%
3/34
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
2/28
|
3.2%
1/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
57.1%
16/28
|
58.1%
18/31
|
57.7%
15/26
|
55.9%
19/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
6/28
|
22.6%
7/31
|
15.4%
4/26
|
14.7%
5/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
4/28
|
16.1%
5/31
|
11.5%
3/26
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.7%
3/28
|
0.00%
0/31
|
0.00%
0/26
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.7%
3/28
|
3.2%
1/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/28
|
0.00%
0/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.6%
1/28
|
6.5%
2/31
|
0.00%
0/26
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
17.9%
5/28
|
29.0%
9/31
|
19.2%
5/26
|
29.4%
10/34
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
4/28
|
22.6%
7/31
|
15.4%
4/26
|
14.7%
5/34
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28
|
9.7%
3/31
|
0.00%
0/26
|
11.8%
4/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28
|
6.5%
2/31
|
0.00%
0/26
|
11.8%
4/34
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
10.7%
3/28
|
9.7%
3/31
|
3.8%
1/26
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
2/28
|
6.5%
2/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/28
|
6.5%
2/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
3.6%
1/28
|
3.2%
1/31
|
0.00%
0/26
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28
|
6.5%
2/31
|
7.7%
2/26
|
5.9%
2/34
|
|
Vascular disorders
Hypertension
|
75.0%
21/28
|
80.6%
25/31
|
57.7%
15/26
|
55.9%
19/34
|
|
Vascular disorders
Flushing
|
0.00%
0/28
|
6.5%
2/31
|
3.8%
1/26
|
0.00%
0/34
|
|
Vascular disorders
Hypotension
|
7.1%
2/28
|
0.00%
0/31
|
3.8%
1/26
|
2.9%
1/34
|
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