Trial Outcomes & Findings for ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA) (NCT NCT00090363)
NCT ID: NCT00090363
Last Updated: 2013-01-08
Results Overview
Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
447 participants
Primary outcome timeframe
Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Results posted on
2013-01-08
Participant Flow
447 patients with prostate cancer who had bone metastases with no pain or mild symptoms of pain and a rising serum Prostate Specific Antigen (PSA), despite a serum testosterone of \<= 2.4 nmol/L (70 ng/dL), were recruited between 14th July 2004 and 10th January 2006.
135 of the 447 enrolled patients were not randomised to treatments groups: 126 failed screening and 9 did not meet one or more of the study inclusion or exclusion criteria.
Participant milestones
| Measure |
Placebo
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
98
|
|
Overall Study
Received Study Treatment.
|
107
|
107
|
98
|
|
Overall Study
COMPLETED
|
1
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
106
|
107
|
96
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
6
|
|
Overall Study
Study-specific discontinuation criteria
|
75
|
74
|
62
|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
0
|
1
|
|
Overall Study
Consent expired
|
7
|
10
|
9
|
|
Overall Study
Reasons not specified
|
2
|
1
|
1
|
|
Overall Study
Continuing on study off treatment
|
14
|
13
|
16
|
Baseline Characteristics
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71 years
STANDARD_DEVIATION 9 • n=5 Participants
|
70 years
STANDARD_DEVIATION 8 • n=7 Participants
|
69 years
STANDARD_DEVIATION 8 • n=5 Participants
|
70 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
312 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
106 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not a specific ethnic group
|
99 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
281 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.
Outcome measures
| Measure |
Placebo
n=107 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Time to Progression (TTP)
|
111 Days
Interval 77.0 to 252.0
|
138 Days
Interval 80.0 to 247.0
|
113 Days
Interval 80.0 to 279.0
|
SECONDARY outcome
Timeframe: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).Median time (in days) from randomisation until death using the Kaplan-Meier method.
Outcome measures
| Measure |
Placebo
n=107 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Time to Death
|
596 Days
Interval 317.0 to 893.0
|
706 Days
Interval 457.0 to 1043.0
|
717 Days
Interval 452.0 to 1232.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).Population: The analysis population only includes patients with baseline and Week 12 PSA measurements
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
Outcome measures
| Measure |
Placebo
n=63 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=69 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=56 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Change in Total Prostate Specific Antigen (PSA) Over Time
|
110.4 Percentage Change in PSA
Standard Deviation 179.16
|
131.6 Percentage Change in PSA
Standard Deviation 454.35
|
69.34 Percentage Change in PSA
Standard Deviation 99.14
|
SECONDARY outcome
Timeframe: For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).Population: Only patients with measurable disease at the baseline were included in the analysis.
Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.
Outcome measures
| Measure |
Placebo
n=51 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=44 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=41 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.
Outcome measures
| Measure |
Placebo
n=107 Participants
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 Participants
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 Participants
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Change in Number of Bone Metastases Over Time
|
187.1 Percentage Change
Standard Deviation 212.6
|
113.4 Percentage Change
Standard Deviation 195.6
|
189 Percentage Change
Standard Deviation 245.2
|
Adverse Events
Placebo
Serious events: 26 serious events
Other events: 93 other events
Deaths: 0 deaths
ZD4054 10 mg
Serious events: 18 serious events
Other events: 86 other events
Deaths: 0 deaths
ZD4054 15 mg
Serious events: 16 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=107 participants at risk
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 participants at risk
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 participants at risk
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/107
|
2.8%
3/107
|
1.0%
1/98
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/107
|
0.93%
1/107
|
2.0%
2/98
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.93%
1/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/107
|
2.8%
3/107
|
0.00%
0/98
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.00%
0/107
|
1.9%
2/107
|
0.00%
0/98
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Eye disorders
Macular Hole
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Gastrointestinal disorders
Oesophagitis
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Gastrointestinal disorders
Proctitis Haemorrhagic
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Gastrointestinal disorders
Small Intestinal Haemorrhage
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
General disorders
Fatigue
|
0.93%
1/107
|
0.93%
1/107
|
0.00%
0/98
|
|
General disorders
Feeling Hot
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
General disorders
Non-Cardiac Chest Pain
|
0.93%
1/107
|
0.93%
1/107
|
0.00%
0/98
|
|
General disorders
Oedema Peripheral
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
General disorders
Catheter Related Complication
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
General disorders
Chest Discomfort
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
General disorders
Death
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
General disorders
Pyrexia
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Infections and infestations
Cellulitis
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Infections and infestations
Pneumonia
|
0.93%
1/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Infections and infestations
Sepsis
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Infections and infestations
Lung Infection
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Infections and infestations
Urosepsis
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Colonic Neoplasm
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lymph Nodes
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Nervous system disorders
Dysarthria
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Nervous system disorders
Loss Of Consciousness
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/107
|
0.00%
0/107
|
1.0%
1/98
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/107
|
0.93%
1/107
|
2.0%
2/98
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Dysuria
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.93%
1/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/107
|
0.00%
0/107
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.93%
1/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/107
|
0.93%
1/107
|
0.00%
0/98
|
Other adverse events
| Measure |
Placebo
n=107 participants at risk
Matching placebo oral tablet once daily, with best supportive care
|
ZD4054 10 mg
n=107 participants at risk
ZD4054 10 mg oral tablet once daily, with best supportive care
|
ZD4054 15 mg
n=98 participants at risk
ZD4054 15 mg oral tablet once daily, with best supportive care
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
6/107
|
0.00%
0/107
|
2.0%
2/98
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.5%
7/107
|
0.00%
0/107
|
3.1%
3/98
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
7/107
|
5.6%
6/107
|
3.1%
3/98
|
|
Metabolism and nutrition disorders
Anorexia
|
9.3%
10/107
|
11.2%
12/107
|
8.2%
8/98
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
12/107
|
9.3%
10/107
|
8.2%
8/98
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.8%
19/107
|
16.8%
18/107
|
17.3%
17/98
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.6%
6/107
|
9.3%
10/107
|
8.2%
8/98
|
|
Gastrointestinal disorders
Constipation
|
10.3%
11/107
|
12.1%
13/107
|
18.4%
18/98
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
5/107
|
4.7%
5/107
|
7.1%
7/98
|
|
Psychiatric disorders
Depression
|
0.93%
1/107
|
5.6%
6/107
|
0.00%
0/98
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
5/107
|
6.5%
7/107
|
7.1%
7/98
|
|
Nervous system disorders
Dizziness
|
2.8%
3/107
|
7.5%
8/107
|
8.2%
8/98
|
|
Gastrointestinal disorders
Dry Mouth
|
8.4%
9/107
|
6.5%
7/107
|
8.2%
8/98
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
6/107
|
15.9%
17/107
|
6.1%
6/98
|
|
General disorders
Fatigue
|
6.5%
7/107
|
16.8%
18/107
|
10.2%
10/98
|
|
Vascular disorders
Flushing
|
5.6%
6/107
|
4.7%
5/107
|
0.00%
0/98
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
3.7%
4/107
|
0.00%
0/107
|
7.1%
7/98
|
|
Renal and urinary disorders
Haematuria
|
3.7%
4/107
|
5.6%
6/107
|
4.1%
4/98
|
|
Nervous system disorders
Headache
|
41.1%
44/107
|
36.4%
39/107
|
13.3%
13/98
|
|
Vascular disorders
Hot Flush
|
7.5%
8/107
|
4.7%
5/107
|
6.1%
6/98
|
|
Infections and infestations
Influenza
|
3.7%
4/107
|
5.6%
6/107
|
5.1%
5/98
|
|
Psychiatric disorders
Insomnia
|
10.3%
11/107
|
5.6%
6/107
|
10.2%
10/98
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.7%
4/107
|
2.8%
3/107
|
6.1%
6/98
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.5%
8/107
|
3.7%
4/107
|
9.2%
9/98
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
8/107
|
5.6%
6/107
|
3.1%
3/98
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
31.8%
34/107
|
29.0%
31/107
|
4.1%
4/98
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
8/107
|
4.7%
5/107
|
8.2%
8/98
|
|
Gastrointestinal disorders
Nausea
|
12.1%
13/107
|
17.8%
19/107
|
20.4%
20/98
|
|
General disorders
Oedema Peripheral
|
43.9%
47/107
|
39.3%
42/107
|
11.2%
11/98
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.5%
7/107
|
9.3%
10/107
|
12.2%
12/98
|
|
Renal and urinary disorders
Pollakiuria
|
0.93%
1/107
|
6.5%
7/107
|
3.1%
3/98
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
2/107
|
0.93%
1/107
|
5.1%
5/98
|
|
General disorders
Pyrexia
|
6.5%
7/107
|
4.7%
5/107
|
5.1%
5/98
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
14.0%
15/107
|
15.9%
17/107
|
3.1%
3/98
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
3/107
|
2.8%
3/107
|
8.2%
8/98
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
7/107
|
5.6%
6/107
|
9.2%
9/98
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca can review results communications prior to public release and may within 30 days of receipt require that submission or disclosure be delayed for up to 2 months in order to file patent applications. AstraZeneca can also, within 30 days of receipt, require amendments to be made in order to protect its patent and / or corporate interests.
- Publication restrictions are in place
Restriction type: OTHER