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Trial record 9 of 647 for:    Russian Federation | Chile

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)

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ClinicalTrials.gov Identifier: NCT00626548
Recruitment Status : Terminated (early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints)
First Posted : February 29, 2008
Results First Posted : June 1, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: ZD4054
Drug: Palcebo
Enrollment 2577
Recruitment Details 2577 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 15th January 2008 and 3rd May 2011
Pre-assignment Details 1156 of the 2577 enrolled patients were not randomised to treatment groups as they failed screening
Arm/Group Title ZD4054 Placebo
Hide Arm/Group Description ZD4054 10 mg oral tablet once daily Placebo oral tablet once daily
Period Title: Overall Study
Started 705 716
Patients Received Treatment 703 712
Completed 0 0
Not Completed 705 716
Reason Not Completed
Adverse Event             164             44
Withdrawal by Subject             42             46
Protocol Violation             4             11
Lost to Follow-up             2             2
Other termination reason             493             613
Arm/Group Title ZD4054 Placebo Total
Hide Arm/Group Description ZD4054 10 mg oral tablet once daily Placebo oral tablet once daily Total of all reporting groups
Overall Number of Baseline Participants 705 716 1421
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Overall Number Analyzed 705 participants 716 participants 1421 participants
72.4  (7.8) 72.5  (7.8) 72.45  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 705 participants 716 participants 1421 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
705
 100.0%
716
 100.0%
1421
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Number of participants who have died at early analysis data cut off (DCO)
Time Frame From date of randomization until date of death, assessed up to 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)
Arm/Group Title ZD4054 Placebo
Hide Arm/Group Description:
ZD4054 10 mg oral tablet once daily
Placebo oral tablet once daily
Overall Number of Participants Analyzed 592 589
Measure Type: Number
Unit of Measure: Participants
40 39
2.Primary Outcome
Title Progression Free Survival
Hide Description 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
Time Frame Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)
Arm/Group Title ZD4054 Placebo
Hide Arm/Group Description:
ZD4054 10 mg oral tablet once daily
Placebo oral tablet once daily
Overall Number of Participants Analyzed 592 589
Measure Type: Number
Unit of Measure: Participants
131 162
3.Secondary Outcome
Title Health Related Quality of Life
Hide Description [Not Specified]
Time Frame Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Prostate-specific Antigen (PSA) Progression
Hide Description [Not Specified]
Time Frame Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Symptomatic Progression
Hide Description [Not Specified]
Time Frame Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZD4054 Placebo
Hide Arm/Group Description ZD4054 10 mg oral tablet once daily Placebo oral tablet once daily
All-Cause Mortality
ZD4054 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZD4054 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   148/703 (21.05%)   138/712 (19.38%) 
Blood and lymphatic system disorders     
Disseminated Intravascular Coagulation  1  2/703 (0.28%)  0/712 (0.00%) 
Anaemia  1  1/703 (0.14%)  1/712 (0.14%) 
Febrile Neutropenia  1  1/703 (0.14%)  0/712 (0.00%) 
Hilar Lymphadenopathy  1  1/703 (0.14%)  0/712 (0.00%) 
Iron Deficiency Anaemia  1  0/703 (0.00%)  1/712 (0.14%) 
Lymphadenopathy  1  1/703 (0.14%)  0/712 (0.00%) 
Neutropenia  1  1/703 (0.14%)  1/712 (0.14%) 
Pancytopenia  1  0/703 (0.00%)  1/712 (0.14%) 
Cardiac disorders     
Cardiac Failure  1  9/703 (1.28%)  3/712 (0.42%) 
Angina Pectoris  1  1/703 (0.14%)  7/712 (0.98%) 
Myocardial Infarction  1  5/703 (0.71%)  3/712 (0.42%) 
Atrial Fibrillation  1  4/703 (0.57%)  2/712 (0.28%) 
Coronary Artery Disease  1  3/703 (0.43%)  0/712 (0.00%) 
Acute Myocardial Infarction  1  2/703 (0.28%)  2/712 (0.28%) 
Cardiac Arrest  1  0/703 (0.00%)  2/712 (0.28%) 
Cardiac Failure Congestive  1  2/703 (0.28%)  1/712 (0.14%) 
Cardio-Respiratory Arrest  1  0/703 (0.00%)  2/712 (0.28%) 
Acute Coronary Syndrome  1  1/703 (0.14%)  0/712 (0.00%) 
Angina Unstable  1  0/703 (0.00%)  1/712 (0.14%) 
Atrial Flutter  1  1/703 (0.14%)  0/712 (0.00%) 
Bradycardia  1  1/703 (0.14%)  1/712 (0.14%) 
Cardiac Disorder  1  1/703 (0.14%)  0/712 (0.00%) 
Cardiac Failure Acute  1  1/703 (0.14%)  0/712 (0.00%) 
Cardiac Failure Chronic  1  0/703 (0.00%)  1/712 (0.14%) 
Diastolic Dysfunction  1  1/703 (0.14%)  0/712 (0.00%) 
Hypertensive Cardiomyopathy  1  1/703 (0.14%)  0/712 (0.00%) 
Mitral Valve Incompetence  1  1/703 (0.14%)  1/712 (0.14%) 
Prinzmetal Angina  1  0/703 (0.00%)  1/712 (0.14%) 
Sinus Bradycardia  1  1/703 (0.14%)  0/712 (0.00%) 
Ventricular Fibrillation  1  0/703 (0.00%)  1/712 (0.14%) 
Congenital, familial and genetic disorders     
Congenital Aortic Valve Stenosis  1  1/703 (0.14%)  0/712 (0.00%) 
Phimosis  1  1/703 (0.14%)  0/712 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  2/703 (0.28%)  0/712 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  1/703 (0.14%)  0/712 (0.00%) 
Eye disorders     
Cataract  1  2/703 (0.28%)  1/712 (0.14%) 
Macular Hole  1  0/703 (0.00%)  1/712 (0.14%) 
Gastrointestinal disorders     
Abdominal Pain  1  2/703 (0.28%)  0/712 (0.00%) 
Diarrhoea  1  2/703 (0.28%)  1/712 (0.14%) 
Inguinal Hernia  1  2/703 (0.28%)  2/712 (0.28%) 
Abdominal Hernia  1  1/703 (0.14%)  0/712 (0.00%) 
Abdominal Pain Upper  1  0/703 (0.00%)  1/712 (0.14%) 
Abdominal Wall Haematoma  1  0/703 (0.00%)  1/712 (0.14%) 
Constipation  1  0/703 (0.00%)  1/712 (0.14%) 
Duodenitis  1  1/703 (0.14%)  0/712 (0.00%) 
Dyspepsia  1  0/703 (0.00%)  1/712 (0.14%) 
Food Poisoning  1  0/703 (0.00%)  1/712 (0.14%) 
Gastric Haemorrhage  1  1/703 (0.14%)  1/712 (0.14%) 
Gastric Ulcer Haemorrhage  1  1/703 (0.14%)  0/712 (0.00%) 
Gastritis  1  1/703 (0.14%)  1/712 (0.14%) 
Gastritis Haemorrhagic  1  1/703 (0.14%)  0/712 (0.00%) 
Intestinal Obstruction  1  1/703 (0.14%)  1/712 (0.14%) 
Large Intestine Perforation  1  1/703 (0.14%)  0/712 (0.00%) 
Mallory-Weiss Syndrome  1  1/703 (0.14%)  0/712 (0.00%) 
Pancreatitis Acute  1  1/703 (0.14%)  0/712 (0.00%) 
Peptic Ulcer Haemorrhage  1  0/703 (0.00%)  1/712 (0.14%) 
Pneumatosis Intestinalis  1  0/703 (0.00%)  1/712 (0.14%) 
Rectal Haemorrhage  1  0/703 (0.00%)  1/712 (0.14%) 
Rectourethral Fistula  1  1/703 (0.14%)  0/712 (0.00%) 
Small Intestinal Obstruction  1  0/703 (0.00%)  1/712 (0.14%) 
Vomiting  1  0/703 (0.00%)  1/712 (0.14%) 
General disorders     
Oedema Peripheral  1  4/703 (0.57%)  0/712 (0.00%) 
Death  1  2/703 (0.28%)  1/712 (0.14%) 
Pyrexia  1  0/703 (0.00%)  2/712 (0.28%) 
Asthenia  1  1/703 (0.14%)  1/712 (0.14%) 
Chest Pain  1  1/703 (0.14%)  0/712 (0.00%) 
Device Dislocation  1  0/703 (0.00%)  1/712 (0.14%) 
General Physical Health Deterioration  1  1/703 (0.14%)  0/712 (0.00%) 
Granuloma  1  0/703 (0.00%)  1/712 (0.14%) 
Hypothermia  1  1/703 (0.14%)  0/712 (0.00%) 
Impaired Healing  1  1/703 (0.14%)  0/712 (0.00%) 
Malaise  1  0/703 (0.00%)  1/712 (0.14%) 
Medical Device Complication  1  0/703 (0.00%)  1/712 (0.14%) 
Multi-Organ Failure  1  0/703 (0.00%)  1/712 (0.14%) 
Non-Cardiac Chest Pain  1  0/703 (0.00%)  1/712 (0.14%) 
Hepatobiliary disorders     
Bile Duct Stone  1  1/703 (0.14%)  1/712 (0.14%) 
Cholecystitis Acute  1  1/703 (0.14%)  0/712 (0.00%) 
Cholelithiasis  1  0/703 (0.00%)  1/712 (0.14%) 
Hepatic Failure  1  0/703 (0.00%)  1/712 (0.14%) 
Hepatic Function Abnormal  1  1/703 (0.14%)  1/712 (0.14%) 
Liver Disorder  1  1/703 (0.14%)  0/712 (0.00%) 
Infections and infestations     
Pneumonia  1  7/703 (1.00%)  5/712 (0.70%) 
Urinary Tract Infection  1  2/703 (0.28%)  3/712 (0.42%) 
Bronchopneumonia  1  2/703 (0.28%)  0/712 (0.00%) 
Lower Respiratory Tract Infection  1  2/703 (0.28%)  0/712 (0.00%) 
Pyelonephritis  1  0/703 (0.00%)  2/712 (0.28%) 
Upper Respiratory Tract Infection  1  2/703 (0.28%)  0/712 (0.00%) 
Anal Abscess  1  1/703 (0.14%)  0/712 (0.00%) 
Appendicitis  1  1/703 (0.14%)  0/712 (0.00%) 
Cellulitis  1  1/703 (0.14%)  1/712 (0.14%) 
Chronic Sinusitis  1  1/703 (0.14%)  0/712 (0.00%) 
Cystitis  1  0/703 (0.00%)  1/712 (0.14%) 
Diverticulitis  1  0/703 (0.00%)  1/712 (0.14%) 
Lung Infection  1  0/703 (0.00%)  1/712 (0.14%) 
Parainfluenzae Virus Infection  1  1/703 (0.14%)  0/712 (0.00%) 
Pneumonia Bacterial  1  0/703 (0.00%)  1/712 (0.14%) 
Pyelonephritis Acute  1  0/703 (0.00%)  1/712 (0.14%) 
Respiratory Tract Infection  1  1/703 (0.14%)  1/712 (0.14%) 
Scrotal Abscess  1  0/703 (0.00%)  1/712 (0.14%) 
Septic Shock  1  0/703 (0.00%)  1/712 (0.14%) 
Sinusitis  1  0/703 (0.00%)  1/712 (0.14%) 
Staphylococcal Sepsis  1  0/703 (0.00%)  1/712 (0.14%) 
Tooth Abscess  1  1/703 (0.14%)  0/712 (0.00%) 
Urosepsis  1  0/703 (0.00%)  1/712 (0.14%) 
Wound Infection  1  0/703 (0.00%)  1/712 (0.14%) 
Injury, poisoning and procedural complications     
Chest Injury  1  0/703 (0.00%)  2/712 (0.28%) 
Rib Fracture  1  0/703 (0.00%)  2/712 (0.28%) 
Subdural Haematoma  1  2/703 (0.28%)  1/712 (0.14%) 
Cystitis Radiation  1  1/703 (0.14%)  1/712 (0.14%) 
Fall  1  0/703 (0.00%)  1/712 (0.14%) 
Femur Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Gastroenteritis Radiation  1  1/703 (0.14%)  0/712 (0.00%) 
Heat Illness  1  0/703 (0.00%)  1/712 (0.14%) 
Hip Fracture  1  1/703 (0.14%)  1/712 (0.14%) 
Injury  1  1/703 (0.14%)  0/712 (0.00%) 
Open Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Patella Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Radiation Proctopathy  1  1/703 (0.14%)  0/712 (0.00%) 
Spinal Compression Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Thoracic Vertebral Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Ulna Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Upper Limb Fracture  1  1/703 (0.14%)  1/712 (0.14%) 
Wrist Fracture  1  0/703 (0.00%)  1/712 (0.14%) 
Haemoglobin Decreased  1  0/703 (0.00%)  1/712 (0.14%) 
International Normalised Ratio Increased  1  0/703 (0.00%)  1/712 (0.14%) 
Metabolism and nutrition disorders     
Diabetes Mellitus  1  2/703 (0.28%)  2/712 (0.28%) 
Diabetic Foot  1  1/703 (0.14%)  1/712 (0.14%) 
Hyponatraemia  1  1/703 (0.14%)  0/712 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/703 (0.14%)  2/712 (0.28%) 
Bone Pain  1  1/703 (0.14%)  0/712 (0.00%) 
Intervertebral Disc Protrusion  1  1/703 (0.14%)  1/712 (0.14%) 
Musculoskeletal Chest Pain  1  1/703 (0.14%)  0/712 (0.00%) 
Musculoskeletal Pain  1  0/703 (0.00%)  1/712 (0.14%) 
Osteoporotic Fracture  1  1/703 (0.14%)  0/712 (0.00%) 
Spinal Column Stenosis  1  0/703 (0.00%)  1/712 (0.14%) 
Systemic Lupus Erythematosus  1  0/703 (0.00%)  1/712 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric Cancer  1  2/703 (0.28%)  5/712 (0.70%) 
Basal Cell Carcinoma  1  4/703 (0.57%)  1/712 (0.14%) 
Colon Cancer  1  1/703 (0.14%)  3/712 (0.42%) 
Rectal Cancer  1  0/703 (0.00%)  2/712 (0.28%) 
Benign Urinary Tract Neoplasm  1  1/703 (0.14%)  0/712 (0.00%) 
Bladder Cancer  1  1/703 (0.14%)  1/712 (0.14%) 
Bladder Transitional Cell Carcinoma  1  1/703 (0.14%)  0/712 (0.00%) 
Bladder Transitional Cell Carcinoma Recurrent  1  0/703 (0.00%)  1/712 (0.14%) 
Colorectal Cancer  1  1/703 (0.14%)  0/712 (0.00%) 
Gastrointestinal Tract Adenoma  1  1/703 (0.14%)  0/712 (0.00%) 
Glioblastoma  1  0/703 (0.00%)  1/712 (0.14%) 
Hepatic Neoplasm Malignant  1  0/703 (0.00%)  1/712 (0.14%) 
Lung Neoplasm Malignant  1  0/703 (0.00%)  1/712 (0.14%) 
Malignant Melanoma  1  0/703 (0.00%)  1/712 (0.14%) 
Myelodysplastic Syndrome  1  1/703 (0.14%)  0/712 (0.00%) 
Neuroendocrine Carcinoma  1  1/703 (0.14%)  0/712 (0.00%) 
Pancreatic Carcinoma  1  1/703 (0.14%)  0/712 (0.00%) 
Pancreatic Carcinoma Metastatic  1  1/703 (0.14%)  0/712 (0.00%) 
Porocarcinoma  1  0/703 (0.00%)  1/712 (0.14%) 
Renal Neoplasm  1  1/703 (0.14%)  0/712 (0.00%) 
Small Cell Lung Cancer Stage Unspecified  1  1/703 (0.14%)  0/712 (0.00%) 
Transitional Cell Carcinoma  1  1/703 (0.14%)  0/712 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident  1  2/703 (0.28%)  1/712 (0.14%) 
Dizziness  1  2/703 (0.28%)  1/712 (0.14%) 
Ischaemic Stroke  1  1/703 (0.14%)  2/712 (0.28%) 
Syncope  1  2/703 (0.28%)  0/712 (0.00%) 
Transient Ischaemic Attack  1  2/703 (0.28%)  1/712 (0.14%) 
Brain Stem Stroke  1  1/703 (0.14%)  0/712 (0.00%) 
Cerebellar Haemorrhage  1  0/703 (0.00%)  1/712 (0.14%) 
Cerebral Haemorrhage  1  1/703 (0.14%)  0/712 (0.00%) 
Cerebral Infarction  1  0/703 (0.00%)  1/712 (0.14%) 
Cerebral Ischaemia  1  1/703 (0.14%)  1/712 (0.14%) 
Cerebrovascular Disorder  1  0/703 (0.00%)  1/712 (0.14%) 
Cerebrovascular Insufficiency  1  1/703 (0.14%)  0/712 (0.00%) 
Leukoencephalopathy  1  1/703 (0.14%)  0/712 (0.00%) 
Parkinsonism  1  1/703 (0.14%)  0/712 (0.00%) 
Subarachnoid Haemorrhage  1  0/703 (0.00%)  1/712 (0.14%) 
Psychiatric disorders     
Completed Suicide  1  1/703 (0.14%)  0/712 (0.00%) 
Delirium  1  1/703 (0.14%)  0/712 (0.00%) 
Suicidal Ideation  1  0/703 (0.00%)  1/712 (0.14%) 
Renal and urinary disorders     
Hydronephrosis  1  1/703 (0.14%)  7/712 (0.98%) 
Renal Failure Acute  1  5/703 (0.71%)  2/712 (0.28%) 
Calculus Ureteric  1  3/703 (0.43%)  0/712 (0.00%) 
Renal Failure  1  2/703 (0.28%)  3/712 (0.42%) 
Urinary Tract Obstruction  1  1/703 (0.14%)  3/712 (0.42%) 
Haematuria  1  1/703 (0.14%)  2/712 (0.28%) 
Renal Impairment  1  2/703 (0.28%)  0/712 (0.00%) 
Urinary Retention  1  2/703 (0.28%)  1/712 (0.14%) 
Azotaemia  1  1/703 (0.14%)  0/712 (0.00%) 
Bladder Stenosis  1  0/703 (0.00%)  1/712 (0.14%) 
Calculus Bladder  1  1/703 (0.14%)  0/712 (0.00%) 
Calculus Urinary  1  1/703 (0.14%)  0/712 (0.00%) 
Cystitis Haemorrhagic  1  0/703 (0.00%)  1/712 (0.14%) 
Renal Disorder  1  1/703 (0.14%)  0/712 (0.00%) 
Urethral Stenosis  1  1/703 (0.14%)  0/712 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  0/703 (0.00%)  1/712 (0.14%) 
Calculus Prostatic  1  1/703 (0.14%)  0/712 (0.00%) 
Pelvic Haematoma  1  1/703 (0.14%)  0/712 (0.00%) 
Prostatic Haemorrhage  1  0/703 (0.00%)  1/712 (0.14%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  1  3/703 (0.43%)  4/712 (0.56%) 
Chronic Obstructive Pulmonary Disease  1  3/703 (0.43%)  0/712 (0.00%) 
Dyspnoea  1  3/703 (0.43%)  0/712 (0.00%) 
Emphysema  1  2/703 (0.28%)  0/712 (0.00%) 
Pleural Effusion  1  2/703 (0.28%)  0/712 (0.00%) 
Asthma  1  1/703 (0.14%)  0/712 (0.00%) 
Epistaxis  1  0/703 (0.00%)  1/712 (0.14%) 
Lung Consolidation  1  1/703 (0.14%)  0/712 (0.00%) 
Pneumonia Aspiration  1  1/703 (0.14%)  0/712 (0.00%) 
Pneumothorax  1  0/703 (0.00%)  1/712 (0.14%) 
Pulmonary Hypertension  1  1/703 (0.14%)  0/712 (0.00%) 
Pulmonary Infarction  1  0/703 (0.00%)  1/712 (0.14%) 
Sleep Apnoea Syndrome  1  1/703 (0.14%)  0/712 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/703 (0.14%)  0/712 (0.00%) 
Peau D'orange  1  0/703 (0.00%)  1/712 (0.14%) 
Vascular disorders     
Deep Vein Thrombosis  1  2/703 (0.28%)  3/712 (0.42%) 
Aortic Aneurysm  1  0/703 (0.00%)  1/712 (0.14%) 
Arterial Stenosis  1  0/703 (0.00%)  1/712 (0.14%) 
Arteritis  1  0/703 (0.00%)  1/712 (0.14%) 
Femoral Arterial Stenosis  1  1/703 (0.14%)  0/712 (0.00%) 
Iliac Artery Occlusion  1  0/703 (0.00%)  1/712 (0.14%) 
Intermittent Claudication  1  0/703 (0.00%)  1/712 (0.14%) 
Temporal Arteritis  1  0/703 (0.00%)  1/712 (0.14%) 
Thrombosis  1  0/703 (0.00%)  1/712 (0.14%) 
twqVenous Thrombosis  1  0/703 (0.00%)  1/712 (0.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZD4054 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   531/703 (75.53%)   392/712 (55.06%) 
Blood and lymphatic system disorders     
Anaemia  1  46/703 (6.54%)  23/712 (3.23%) 
Gastrointestinal disorders     
Constipation  1  64/703 (9.10%)  76/712 (10.67%) 
Diarrhoea  1  46/703 (6.54%)  63/712 (8.85%) 
Nausea  1  59/703 (8.39%)  61/712 (8.57%) 
General disorders     
Oedema Peripheral  1  268/703 (38.12%)  88/712 (12.36%) 
Fatigue  1  71/703 (10.10%)  79/712 (11.10%) 
Asthenia  1  35/703 (4.98%)  43/712 (6.04%) 
Infections and infestations     
Rhinitis  1  56/703 (7.97%)  17/712 (2.39%) 
Urinary Tract Infection  1  43/703 (6.12%)  54/712 (7.58%) 
Nasopharyngitis  1  34/703 (4.84%)  45/712 (6.32%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  40/703 (5.69%)  33/712 (4.63%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  40/703 (5.69%)  54/712 (7.58%) 
Back Pain  1  33/703 (4.69%)  49/712 (6.88%) 
Nervous system disorders     
Headache  1  188/703 (26.74%)  82/712 (11.52%) 
Dizziness  1  46/703 (6.54%)  39/712 (5.48%) 
Renal and urinary disorders     
Haematuria  1  23/703 (3.27%)  36/712 (5.06%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  176/703 (25.04%)  39/712 (5.48%) 
Dyspnoea  1  49/703 (6.97%)  33/712 (4.63%) 
Nasal Obstruction  1  48/703 (6.83%)  4/712 (0.56%) 
Cough  1  36/703 (5.12%)  34/712 (4.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.

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

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00626548     History of Changes
Other Study ID Numbers: D4320C00015
First Submitted: January 24, 2008
First Posted: February 29, 2008
Results First Submitted: April 26, 2012
Results First Posted: June 1, 2012
Last Update Posted: September 3, 2012