Trial Outcomes & Findings for A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (NCT NCT00626548)
NCT ID: NCT00626548
Last Updated: 2012-09-03
Results Overview
Number of participants who have died at early analysis data cut off (DCO)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2577 participants
Primary outcome timeframe
From date of randomization until date of death, assessed up to 33 months
Results posted on
2012-09-03
Participant Flow
2577 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 15th January 2008 and 3rd May 2011
1156 of the 2577 enrolled patients were not randomised to treatment groups as they failed screening
Participant milestones
| Measure |
ZD4054
ZD4054 10 mg oral tablet once daily
|
Placebo
Placebo oral tablet once daily
|
|---|---|---|
|
Overall Study
STARTED
|
705
|
716
|
|
Overall Study
Patients Received Treatment
|
703
|
712
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
705
|
716
|
Reasons for withdrawal
| Measure |
ZD4054
ZD4054 10 mg oral tablet once daily
|
Placebo
Placebo oral tablet once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
164
|
44
|
|
Overall Study
Withdrawal by Subject
|
42
|
46
|
|
Overall Study
Protocol Violation
|
4
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Other termination reason
|
493
|
613
|
Baseline Characteristics
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
ZD4054
n=705 Participants
ZD4054 10 mg oral tablet once daily
|
Placebo
n=716 Participants
Placebo oral tablet once daily
|
Total
n=1421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
Overall
|
72.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
72.45 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
705 Participants
n=5 Participants
|
716 Participants
n=7 Participants
|
1421 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until date of death, assessed up to 33 monthsPopulation: The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)
Number of participants who have died at early analysis data cut off (DCO)
Outcome measures
| Measure |
ZD4054
n=592 Participants
ZD4054 10 mg oral tablet once daily
|
Placebo
n=589 Participants
Placebo oral tablet once daily
|
|---|---|---|
|
Overall Survival
|
40 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeksPopulation: The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)
Number of participants who have a progression event at the early analysis DCO, 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
Outcome measures
| Measure |
ZD4054
n=592 Participants
ZD4054 10 mg oral tablet once daily
|
Placebo
n=589 Participants
Placebo oral tablet once daily
|
|---|---|---|
|
Progression Free Survival
|
131 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeksOutcome measures
Outcome data not reported
Adverse Events
ZD4054
Serious events: 148 serious events
Other events: 531 other events
Deaths: 0 deaths
Placebo
Serious events: 138 serious events
Other events: 392 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZD4054
n=703 participants at risk
ZD4054 10 mg oral tablet once daily
|
Placebo
n=712 participants at risk
Placebo oral tablet once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.28%
2/703
|
0.00%
0/712
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/703
|
0.14%
1/712
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.14%
1/703
|
0.00%
0/712
|
|
Blood and lymphatic system disorders
Hilar Lymphadenopathy
|
0.14%
1/703
|
0.00%
0/712
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/703
|
0.14%
1/712
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.14%
1/703
|
0.00%
0/712
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.14%
1/703
|
0.14%
1/712
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/703
|
0.14%
1/712
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
9/703
|
0.42%
3/712
|
|
Cardiac disorders
Angina Pectoris
|
0.14%
1/703
|
0.98%
7/712
|
|
Cardiac disorders
Myocardial Infarction
|
0.71%
5/703
|
0.42%
3/712
|
|
Cardiac disorders
Atrial Fibrillation
|
0.57%
4/703
|
0.28%
2/712
|
|
Cardiac disorders
Coronary Artery Disease
|
0.43%
3/703
|
0.00%
0/712
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.28%
2/703
|
0.28%
2/712
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/703
|
0.28%
2/712
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.28%
2/703
|
0.14%
1/712
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/703
|
0.28%
2/712
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/703
|
0.14%
1/712
|
|
Cardiac disorders
Atrial Flutter
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Bradycardia
|
0.14%
1/703
|
0.14%
1/712
|
|
Cardiac disorders
Cardiac Disorder
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.00%
0/703
|
0.14%
1/712
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Hypertensive Cardiomyopathy
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.14%
1/703
|
0.14%
1/712
|
|
Cardiac disorders
Prinzmetal Angina
|
0.00%
0/703
|
0.14%
1/712
|
|
Cardiac disorders
Sinus Bradycardia
|
0.14%
1/703
|
0.00%
0/712
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/703
|
0.14%
1/712
|
|
Congenital, familial and genetic disorders
Congenital Aortic Valve Stenosis
|
0.14%
1/703
|
0.00%
0/712
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.14%
1/703
|
0.00%
0/712
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
2/703
|
0.00%
0/712
|
|
Endocrine disorders
Hypothyroidism
|
0.14%
1/703
|
0.00%
0/712
|
|
Eye disorders
Cataract
|
0.28%
2/703
|
0.14%
1/712
|
|
Eye disorders
Macular Hole
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.28%
2/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
2/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.28%
2/703
|
0.28%
2/712
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Duodenitis
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.14%
1/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
1/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.14%
1/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Pneumatosis Intestinalis
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Rectourethral Fistula
|
0.14%
1/703
|
0.00%
0/712
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/703
|
0.14%
1/712
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
Oedema Peripheral
|
0.57%
4/703
|
0.00%
0/712
|
|
General disorders
Death
|
0.28%
2/703
|
0.14%
1/712
|
|
General disorders
Pyrexia
|
0.00%
0/703
|
0.28%
2/712
|
|
General disorders
Asthenia
|
0.14%
1/703
|
0.14%
1/712
|
|
General disorders
Chest Pain
|
0.14%
1/703
|
0.00%
0/712
|
|
General disorders
Device Dislocation
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
General Physical Health Deterioration
|
0.14%
1/703
|
0.00%
0/712
|
|
General disorders
Granuloma
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
Hypothermia
|
0.14%
1/703
|
0.00%
0/712
|
|
General disorders
Impaired Healing
|
0.14%
1/703
|
0.00%
0/712
|
|
General disorders
Malaise
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
Medical Device Complication
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/703
|
0.14%
1/712
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/703
|
0.14%
1/712
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.14%
1/703
|
0.14%
1/712
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.14%
1/703
|
0.00%
0/712
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/703
|
0.14%
1/712
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/703
|
0.14%
1/712
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.14%
1/703
|
0.14%
1/712
|
|
Hepatobiliary disorders
Liver Disorder
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Pneumonia
|
1.00%
7/703
|
0.70%
5/712
|
|
Infections and infestations
Urinary Tract Infection
|
0.28%
2/703
|
0.42%
3/712
|
|
Infections and infestations
Bronchopneumonia
|
0.28%
2/703
|
0.00%
0/712
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.28%
2/703
|
0.00%
0/712
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/703
|
0.28%
2/712
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.28%
2/703
|
0.00%
0/712
|
|
Infections and infestations
Anal Abscess
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Appendicitis
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Cellulitis
|
0.14%
1/703
|
0.14%
1/712
|
|
Infections and infestations
Chronic Sinusitis
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Cystitis
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Lung Infection
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Respiratory Tract Infection
|
0.14%
1/703
|
0.14%
1/712
|
|
Infections and infestations
Scrotal Abscess
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Septic Shock
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Sinusitis
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Tooth Abscess
|
0.14%
1/703
|
0.00%
0/712
|
|
Infections and infestations
Urosepsis
|
0.00%
0/703
|
0.14%
1/712
|
|
Infections and infestations
Wound Infection
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.00%
0/703
|
0.28%
2/712
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/703
|
0.28%
2/712
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.28%
2/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.14%
1/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Gastroenteritis Radiation
|
0.14%
1/703
|
0.00%
0/712
|
|
Injury, poisoning and procedural complications
Heat Illness
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.14%
1/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Injury
|
0.14%
1/703
|
0.00%
0/712
|
|
Injury, poisoning and procedural complications
Open Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Radiation Proctopathy
|
0.14%
1/703
|
0.00%
0/712
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.14%
1/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
0.00%
0/703
|
0.14%
1/712
|
|
Injury, poisoning and procedural complications
International Normalised Ratio Increased
|
0.00%
0/703
|
0.14%
1/712
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.28%
2/703
|
0.28%
2/712
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.14%
1/703
|
0.14%
1/712
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.14%
1/703
|
0.00%
0/712
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/703
|
0.28%
2/712
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.14%
1/703
|
0.00%
0/712
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.14%
1/703
|
0.14%
1/712
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.14%
1/703
|
0.00%
0/712
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/703
|
0.14%
1/712
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.14%
1/703
|
0.00%
0/712
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/703
|
0.14%
1/712
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.28%
2/703
|
0.70%
5/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.57%
4/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.14%
1/703
|
0.42%
3/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/703
|
0.28%
2/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Urinary Tract Neoplasm
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.14%
1/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma Recurrent
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Carcinoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/703
|
0.14%
1/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.14%
1/703
|
0.00%
0/712
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.28%
2/703
|
0.14%
1/712
|
|
Nervous system disorders
Dizziness
|
0.28%
2/703
|
0.14%
1/712
|
|
Nervous system disorders
Ischaemic Stroke
|
0.14%
1/703
|
0.28%
2/712
|
|
Nervous system disorders
Syncope
|
0.28%
2/703
|
0.00%
0/712
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.28%
2/703
|
0.14%
1/712
|
|
Nervous system disorders
Brain Stem Stroke
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
0.00%
0/703
|
0.14%
1/712
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/703
|
0.14%
1/712
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.14%
1/703
|
0.14%
1/712
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.00%
0/703
|
0.14%
1/712
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Leukoencephalopathy
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Parkinsonism
|
0.14%
1/703
|
0.00%
0/712
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/703
|
0.14%
1/712
|
|
Psychiatric disorders
Completed Suicide
|
0.14%
1/703
|
0.00%
0/712
|
|
Psychiatric disorders
Delirium
|
0.14%
1/703
|
0.00%
0/712
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/703
|
0.14%
1/712
|
|
Renal and urinary disorders
Hydronephrosis
|
0.14%
1/703
|
0.98%
7/712
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.71%
5/703
|
0.28%
2/712
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.43%
3/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Renal Failure
|
0.28%
2/703
|
0.42%
3/712
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.14%
1/703
|
0.42%
3/712
|
|
Renal and urinary disorders
Haematuria
|
0.14%
1/703
|
0.28%
2/712
|
|
Renal and urinary disorders
Renal Impairment
|
0.28%
2/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Urinary Retention
|
0.28%
2/703
|
0.14%
1/712
|
|
Renal and urinary disorders
Azotaemia
|
0.14%
1/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Bladder Stenosis
|
0.00%
0/703
|
0.14%
1/712
|
|
Renal and urinary disorders
Calculus Bladder
|
0.14%
1/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Calculus Urinary
|
0.14%
1/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/703
|
0.14%
1/712
|
|
Renal and urinary disorders
Renal Disorder
|
0.14%
1/703
|
0.00%
0/712
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.14%
1/703
|
0.00%
0/712
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/703
|
0.14%
1/712
|
|
Reproductive system and breast disorders
Calculus Prostatic
|
0.14%
1/703
|
0.00%
0/712
|
|
Reproductive system and breast disorders
Pelvic Haematoma
|
0.14%
1/703
|
0.00%
0/712
|
|
Reproductive system and breast disorders
Prostatic Haemorrhage
|
0.00%
0/703
|
0.14%
1/712
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.43%
3/703
|
0.56%
4/712
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.43%
3/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
3/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.28%
2/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.28%
2/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/703
|
0.14%
1/712
|
|
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
|
0.14%
1/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.14%
1/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/703
|
0.14%
1/712
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.14%
1/703
|
0.00%
0/712
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.00%
0/703
|
0.14%
1/712
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.14%
1/703
|
0.00%
0/712
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.14%
1/703
|
0.00%
0/712
|
|
Skin and subcutaneous tissue disorders
Peau D'orange
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.28%
2/703
|
0.42%
3/712
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Arterial Stenosis
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Arteritis
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.14%
1/703
|
0.00%
0/712
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Temporal Arteritis
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
Thrombosis
|
0.00%
0/703
|
0.14%
1/712
|
|
Vascular disorders
twqVenous Thrombosis
|
0.00%
0/703
|
0.14%
1/712
|
Other adverse events
| Measure |
ZD4054
n=703 participants at risk
ZD4054 10 mg oral tablet once daily
|
Placebo
n=712 participants at risk
Placebo oral tablet once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
46/703
|
3.2%
23/712
|
|
Gastrointestinal disorders
Constipation
|
9.1%
64/703
|
10.7%
76/712
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
46/703
|
8.8%
63/712
|
|
Gastrointestinal disorders
Nausea
|
8.4%
59/703
|
8.6%
61/712
|
|
General disorders
Oedema Peripheral
|
38.1%
268/703
|
12.4%
88/712
|
|
General disorders
Fatigue
|
10.1%
71/703
|
11.1%
79/712
|
|
General disorders
Asthenia
|
5.0%
35/703
|
6.0%
43/712
|
|
Infections and infestations
Rhinitis
|
8.0%
56/703
|
2.4%
17/712
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
43/703
|
7.6%
54/712
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
34/703
|
6.3%
45/712
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.7%
40/703
|
4.6%
33/712
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
40/703
|
7.6%
54/712
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
33/703
|
6.9%
49/712
|
|
Nervous system disorders
Headache
|
26.7%
188/703
|
11.5%
82/712
|
|
Nervous system disorders
Dizziness
|
6.5%
46/703
|
5.5%
39/712
|
|
Renal and urinary disorders
Haematuria
|
3.3%
23/703
|
5.1%
36/712
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
25.0%
176/703
|
5.5%
39/712
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
49/703
|
4.6%
33/712
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Obstruction
|
6.8%
48/703
|
0.56%
4/712
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
36/703
|
4.8%
34/712
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 3\. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. AstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed to allow for
- Publication restrictions are in place
Restriction type: OTHER