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A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (ENTHUSE M1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00554229
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : May 31, 2012
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: ZD4054
Drug: Placebo
Enrollment 896
Recruitment Details 896 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 20th November 2007 and 13th February 2009.
Pre-assignment Details 302 of the 896 enrolled patients were not randomised to treatments 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 299 295
Patients Who Received Treatment 298 295
Completed 73 70
Not Completed 226 225
Reason Not Completed
Lost to Follow-up             3             6
Withdrawal by Subject             29             37
Adverse Event             71             39
Protocol Violation             3             3
Reason not otherwise captured, eg; death             119             140
Randomised but no treatment received             1             0
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 299 295 594
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Overall Number Analyzed 299 participants 295 participants 594 participants
70.2  (7.8) 70.9  (8.6) 70.5  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 295 participants 594 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
299
 100.0%
295
 100.0%
594
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Median time (in months) from randomisation until death using the Kaplan-Meier method
Time Frame From date of randomization until date of death, assessed up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Full Range)
Unit of Measure: months
24.5
(0.5 to 31.2)
22.5
(0.5 to 29.8)
2.Secondary Outcome
Title Progression Free Survival
Hide Description Median time (in months) from randomisation until clinical progression of disease, 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, using the Kaplan-Meier method
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
6.2
(2.8 to 13.8)
6.5
(2.8 to 13.2)
3.Secondary Outcome
Title Time to Use of Opiates
Hide Description Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method
Time Frame From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
16.7
(7.3 to 27.0)
14.8
(7.9 to 25.8)
4.Secondary Outcome
Title Incidence of Skeletal Related Events
Hide Description Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.
Time Frame From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
18.4
(9.6 to 30.6)
17.1
(9.3 to 25.8)
5.Secondary Outcome
Title Bone Metastases Formation
Hide Description Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method
Time Frame Patients were assessed every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
15.1
(7.2 to 25.5)
11.9
(7.0 to 22.5)
6.Secondary Outcome
Title Health Related Quality of Life
Hide Description Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.
Time Frame Patients were assessed at every visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
5.5
(2.8 to 9.1)
5.5
(2.8 to 9.1)
7.Secondary Outcome
Title Time to Prostate-specific Antigen (PSA) Progression
Hide Description Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.
Time Frame Patients were assessed every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
5.6
(2.9 to 11.1)
5.6
(2.8 to 11.4)
8.Secondary Outcome
Title Time to Pain Progression
Hide Description Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.
Time Frame Patients were assessed every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
9.0
(3.3 to 19.4)
8.4
(3.4 to 19.1)
9.Secondary Outcome
Title Time to Initiation of Chemotherapy
Hide Description Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method
Time Frame Patients were assessed every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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 299 295
Median (Inter-Quartile Range)
Unit of Measure: Months
11.4
(5.8 to 18.5)
10.6
(6.0 to 18.2)
10.Secondary Outcome
Title Pharmacokinetic Characteristics of ZD4054
Hide Description [Not Specified]
Time Frame PK samples were performed at randomisation, Week 4, Week 8 and Week 12
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   --/--   --/-- 
Hide Serious Adverse Events
ZD4054 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   98/298 (32.89%)   105/295 (35.59%) 
Blood and lymphatic system disorders     
Anaemia † 1  6/298 (2.01%)  1/295 (0.34%) 
Febrile Neutropenia † 1  2/298 (0.67%)  3/295 (1.02%) 
Neutropenia † 1  2/298 (0.67%)  3/295 (1.02%) 
Bone Marrow Failure † 1  0/298 (0.00%)  1/295 (0.34%) 
Disseminated Intravascular Coagulation † 1  0/298 (0.00%)  1/295 (0.34%) 
Leukopenia † 1  0/298 (0.00%)  1/295 (0.34%) 
Thrombocytopenia † 1  1/298 (0.34%)  1/295 (0.34%) 
Cardiac disorders     
Cardiac Failure † 1  6/298 (2.01%)  0/295 (0.00%) 
Myocardial Infarction † 1  3/298 (1.01%)  2/295 (0.68%) 
Acute Myocardial Infarction † 1  2/298 (0.67%)  0/295 (0.00%) 
Left Ventricular Failure † 1  0/298 (0.00%)  1/295 (0.34%) 
Angina Unstable † 1  1/298 (0.34%)  0/295 (0.00%) 
Atrial Fibrillation † 1  1/298 (0.34%)  1/295 (0.34%) 
Atrial Flutter † 1  1/298 (0.34%)  1/295 (0.34%) 
Atrioventricular Block † 1  1/298 (0.34%)  0/295 (0.00%) 
Atrioventricular Block Complete † 1  0/298 (0.00%)  1/295 (0.34%) 
Cardiac Failure Acute † 1  0/298 (0.00%)  1/295 (0.34%) 
Cardiac Failure Congestive † 1  1/298 (0.34%)  0/295 (0.00%) 
Cardio-Respiratory Arrest † 1  1/298 (0.34%)  0/295 (0.00%) 
Coronary Artery Stenosis † 1  0/298 (0.00%)  1/295 (0.34%) 
Myocardial Ischaemia † 1  0/298 (0.00%)  1/295 (0.34%) 
Prinzmetal Angina † 1  1/298 (0.34%)  0/295 (0.00%) 
Right Ventricular Failure † 1  1/298 (0.34%)  0/295 (0.00%) 
Sick Sinus Syndrome † 1  0/298 (0.00%)  1/295 (0.34%) 
Supraventricular Tachycardia † 1  1/298 (0.34%)  0/295 (0.00%) 
Ventricular Tachycardia † 1  1/298 (0.34%)  0/295 (0.00%) 
Ear and labyrinth disorders     
Sudden Hearing Loss † 1  1/298 (0.34%)  0/295 (0.00%) 
Eye disorders     
Cataract † 1  1/298 (0.34%)  0/295 (0.00%) 
Retinal Detachment † 1  1/298 (0.34%)  0/295 (0.00%) 
Gastrointestinal disorders     
Constipation † 1  3/298 (1.01%)  1/295 (0.34%) 
Diarrhoea † 1  0/298 (0.00%)  2/295 (0.68%) 
Abdominal Hernia † 1  0/298 (0.00%)  1/295 (0.34%) 
Abdominal Pain † 1  0/298 (0.00%)  1/295 (0.34%) 
Ascites † 1  1/298 (0.34%)  0/295 (0.00%) 
Colitis Ulcerative † 1  0/298 (0.00%)  1/295 (0.34%) 
Colonic Polyp † 1  1/298 (0.34%)  0/295 (0.00%) 
Duodenal Ulcer Perforation † 1  1/298 (0.34%)  0/295 (0.00%) 
Erosive Oesophagitis † 1  0/298 (0.00%)  1/295 (0.34%) 
Gastric Haemorrhage † 1  1/298 (0.34%)  0/295 (0.00%) 
Gastric Ulcer † 1  0/298 (0.00%)  1/295 (0.34%) 
Gastric Ulcer Haemorrhage † 1  1/298 (0.34%)  0/295 (0.00%) 
Gastritis Haemorrhagic † 1  0/298 (0.00%)  1/295 (0.34%) 
Gastrointestinal Haemorrhage † 1  0/298 (0.00%)  1/295 (0.34%) 
Haematemesis † 1  0/298 (0.00%)  1/295 (0.34%) 
Melaena † 1  0/298 (0.00%)  1/295 (0.34%) 
Nausea † 1  1/298 (0.34%)  0/295 (0.00%) 
Pancreatitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Pancreatitis Acute † 1  0/298 (0.00%)  1/295 (0.34%) 
Peptic Ulcer Perforation † 1  0/298 (0.00%)  1/295 (0.34%) 
Retroperitoneal Haemorrhage † 1  1/298 (0.34%)  0/295 (0.00%) 
Vomiting † 1  1/298 (0.34%)  1/295 (0.34%) 
General disorders     
Death † 1  2/298 (0.67%)  7/295 (2.37%) 
Pyrexia † 1  3/298 (1.01%)  2/295 (0.68%) 
Disease Progression † 1  1/298 (0.34%)  2/295 (0.68%) 
Oedema Peripheral † 1  2/298 (0.67%)  0/295 (0.00%) 
Asthenia † 1  0/298 (0.00%)  1/295 (0.34%) 
Chest Discomfort † 1  0/298 (0.00%)  1/295 (0.34%) 
Chest Pain † 1  1/298 (0.34%)  0/295 (0.00%) 
Fatigue † 1  0/298 (0.00%)  1/295 (0.34%) 
General Physical Health Deterioration † 1  1/298 (0.34%)  0/295 (0.00%) 
Malaise † 1  1/298 (0.34%)  0/295 (0.00%) 
Multi-Organ Failure † 1  1/298 (0.34%)  0/295 (0.00%) 
Non-Cardiac Chest Pain † 1  1/298 (0.34%)  1/295 (0.34%) 
Hepatobiliary disorders     
Cholecystitis † 1  0/298 (0.00%)  2/295 (0.68%) 
Bile Duct Obstruction † 1  0/298 (0.00%)  1/295 (0.34%) 
Bile Duct Stone † 1  1/298 (0.34%)  0/295 (0.00%) 
Cholangitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Infections and infestations     
Pneumonia † 1  6/298 (2.01%)  1/295 (0.34%) 
Sepsis † 1  3/298 (1.01%)  3/295 (1.02%) 
Bronchopneumonia † 1  2/298 (0.67%)  0/295 (0.00%) 
Respiratory Tract Infection † 1  0/298 (0.00%)  2/295 (0.68%) 
Septic Shock † 1  0/298 (0.00%)  2/295 (0.68%) 
Abscess Jaw † 1  0/298 (0.00%)  1/295 (0.34%) 
Appendicitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Bronchitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Cellulitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Gastroenteritis † 1  0/298 (0.00%)  1/295 (0.34%) 
Infected Cyst † 1  1/298 (0.34%)  0/295 (0.00%) 
Lower Respiratory Tract Infection † 1  0/298 (0.00%)  1/295 (0.34%) 
Lung Infection † 1  0/298 (0.00%)  1/295 (0.34%) 
Meningitis † 1  1/298 (0.34%)  1/295 (0.34%) 
Necrotising Fasciitis † 1  1/298 (0.34%)  0/295 (0.00%) 
Oesophageal Candidiasis † 1  0/298 (0.00%)  1/295 (0.34%) 
Post Procedural Infection † 1  0/298 (0.00%)  1/295 (0.34%) 
Staphylococcal Infection † 1  0/298 (0.00%)  1/295 (0.34%) 
Urinary Tract Infection † 1  1/298 (0.34%)  1/295 (0.34%) 
Urosepsis † 1  1/298 (0.34%)  0/295 (0.00%) 
Viral Pericarditis † 1  0/298 (0.00%)  1/295 (0.34%) 
Injury, poisoning and procedural complications     
Hip Fracture † 1  0/298 (0.00%)  2/295 (0.68%) 
Subdural Haematoma † 1  2/298 (0.67%)  1/295 (0.34%) 
Cerebral Haemorrhage Traumatic † 1  0/298 (0.00%)  1/295 (0.34%) 
Cervical Vertebral Fracture † 1  1/298 (0.34%)  1/295 (0.34%) 
Cystitis Radiation † 1  0/298 (0.00%)  1/295 (0.34%) 
Femoral Neck Fracture † 1  0/298 (0.00%)  1/295 (0.34%) 
Fibula Fracture † 1  0/298 (0.00%)  1/295 (0.34%) 
Splenic Rupture † 1  1/298 (0.34%)  0/295 (0.00%) 
Subcutaneous Haematoma † 1  0/298 (0.00%)  1/295 (0.34%) 
Therapeutic Agent Toxicity † 1  1/298 (0.34%)  0/295 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia † 1  0/298 (0.00%)  2/295 (0.68%) 
Decreased Appetite † 1  1/298 (0.34%)  1/295 (0.34%) 
Dehydration † 1  1/298 (0.34%)  1/295 (0.34%) 
Diabetes Mellitus † 1  0/298 (0.00%)  1/295 (0.34%) 
Gout † 1  1/298 (0.34%)  0/295 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular Weakness † 1  0/298 (0.00%)  2/295 (0.68%) 
Back Pain † 1  0/298 (0.00%)  1/295 (0.34%) 
Intervertebral Disc Protrusion † 1  0/298 (0.00%)  1/295 (0.34%) 
Osteonecrosis Of Jaw † 1  1/298 (0.34%)  0/295 (0.00%) 
Pain In Extremity † 1  0/298 (0.00%)  1/295 (0.34%) 
Pathological Fracture † 1  1/298 (0.34%)  0/295 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia † 1  1/298 (0.34%)  1/295 (0.34%) 
Bladder Transitional Cell Carcinoma † 1  1/298 (0.34%)  0/295 (0.00%) 
Colon Cancer † 1  1/298 (0.34%)  0/295 (0.00%) 
Gastric Cancer † 1  0/298 (0.00%)  1/295 (0.34%) 
Lung Neoplasm Malignant † 1  0/298 (0.00%)  1/295 (0.34%) 
Metastases To Spine † 1  0/298 (0.00%)  1/295 (0.34%) 
Neoplasm Progression † 1  1/298 (0.34%)  0/295 (0.00%) 
Oesophageal Carcinoma † 1  1/298 (0.34%)  0/295 (0.00%) 
Oesophageal Neoplasm † 1  1/298 (0.34%)  0/295 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident † 1  3/298 (1.01%)  2/295 (0.68%) 
Transient Ischaemic Attack † 1  0/298 (0.00%)  2/295 (0.68%) 
Cerebral Haemorrhage † 1  1/298 (0.34%)  0/295 (0.00%) 
Cerebral Infarction † 1  0/298 (0.00%)  1/295 (0.34%) 
Cerebral Ischaemia † 1  0/298 (0.00%)  1/295 (0.34%) 
Cerebral Thrombosis † 1  1/298 (0.34%)  0/295 (0.00%) 
Cerebrovascular Disorder † 1  1/298 (0.34%)  0/295 (0.00%) 
Convulsion † 1  0/298 (0.00%)  1/295 (0.34%) 
Headache † 1  1/298 (0.34%)  0/295 (0.00%) 
Lethargy † 1  0/298 (0.00%)  1/295 (0.34%) 
Loss Of Consciousness † 1  1/298 (0.34%)  0/295 (0.00%) 
Neuropathy Peripheral † 1  1/298 (0.34%)  0/295 (0.00%) 
Paraesthesia † 1  0/298 (0.00%)  1/295 (0.34%) 
Spinal Cord Compression † 1  1/298 (0.34%)  1/295 (0.34%) 
Trigeminal Neuralgia † 1  0/298 (0.00%)  1/295 (0.34%) 
Vith Nerve Paralysis † 1  0/298 (0.00%)  1/295 (0.34%) 
Psychiatric disorders     
Completed Suicide † 1  0/298 (0.00%)  1/295 (0.34%) 
Delirium † 1  0/298 (0.00%)  1/295 (0.34%) 
Suicide Attempt † 1  0/298 (0.00%)  1/295 (0.34%) 
Renal and urinary disorders     
Renal Failure Acute † 1  1/298 (0.34%)  4/295 (1.36%) 
Urinary Retention † 1  3/298 (1.01%)  0/295 (0.00%) 
Renal Failure † 1  1/298 (0.34%)  2/295 (0.68%) 
Anuria † 1  0/298 (0.00%)  1/295 (0.34%) 
Haematuria † 1  0/298 (0.00%)  1/295 (0.34%) 
Haemorrhage Urinary Tract † 1  0/298 (0.00%)  1/295 (0.34%) 
Hydronephrosis † 1  1/298 (0.34%)  1/295 (0.34%) 
Urethral Stenosis † 1  0/298 (0.00%)  1/295 (0.34%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia † 1  1/298 (0.34%)  0/295 (0.00%) 
Priapism † 1  0/298 (0.00%)  1/295 (0.34%) 
Prostatic Haemorrhage † 1  1/298 (0.34%)  0/295 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism † 1  5/298 (1.68%)  2/295 (0.68%) 
Pleural Effusion † 1  4/298 (1.34%)  0/295 (0.00%) 
Chronic Obstructive Pulmonary Disease † 1  0/298 (0.00%)  3/295 (1.02%) 
Pneumonia Aspiration † 1  0/298 (0.00%)  3/295 (1.02%) 
Asthma † 1  1/298 (0.34%)  0/295 (0.00%) 
Dyspnoea † 1  2/298 (0.67%)  2/295 (0.68%) 
Pulmonary Oedema † 1  2/298 (0.67%)  1/295 (0.34%) 
Epistaxis † 1  1/298 (0.34%)  0/295 (0.00%) 
Hydrothorax † 1  1/298 (0.34%)  0/295 (0.00%) 
Interstitial Lung Disease † 1  0/298 (0.00%)  1/295 (0.34%) 
Obstructive Airways Disorder † 1  0/298 (0.00%)  1/295 (0.34%) 
Pulmonary Hypertension † 1  1/298 (0.34%)  0/295 (0.00%) 
Respiratory Failure † 1  1/298 (0.34%)  1/295 (0.34%) 
Upper Respiratory Tract Inflammation † 1  1/298 (0.34%)  0/295 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer † 1  0/298 (0.00%)  1/295 (0.34%) 
Vascular disorders     
Deep Vein Thrombosis † 1  1/298 (0.34%)  2/295 (0.68%) 
Aortic Dissection † 1  0/298 (0.00%)  1/295 (0.34%) 
Arteriosclerosis † 1  0/298 (0.00%)  1/295 (0.34%) 
Haematoma † 1  1/298 (0.34%)  1/295 (0.34%) 
Iliac Artery Occlusion † 1  0/298 (0.00%)  1/295 (0.34%) 
Lymphoedema † 1  1/298 (0.34%)  0/295 (0.00%) 
Phlebitis † 1  0/298 (0.00%)  1/295 (0.34%) 
Venous Thrombosis Limb † 1  0/298 (0.00%)  1/295 (0.34%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZD4054 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   257/298 (86.24%)   221/295 (74.92%) 
Blood and lymphatic system disorders     
Anaemia † 1  46/298 (15.44%)  33/295 (11.19%) 
Neutropenia † 1  11/298 (3.69%)  16/295 (5.42%) 
Gastrointestinal disorders     
Nausea † 1  62/298 (20.81%)  44/295 (14.92%) 
Constipation † 1  61/298 (20.47%)  51/295 (17.29%) 
Diarrhoea † 1  28/298 (9.40%)  46/295 (15.59%) 
Vomiting † 1  34/298 (11.41%)  23/295 (7.80%) 
General disorders     
Oedema Peripheral † 1  132/298 (44.30%)  56/295 (18.98%) 
Fatigue † 1  58/298 (19.46%)  52/295 (17.63%) 
Pyrexia † 1  30/298 (10.07%)  22/295 (7.46%) 
Asthenia † 1  18/298 (6.04%)  22/295 (7.46%) 
Infections and infestations     
Rhinitis † 1  35/298 (11.74%)  13/295 (4.41%) 
Nasopharyngitis † 1  28/298 (9.40%)  25/295 (8.47%) 
Urinary Tract Infection † 1  19/298 (6.38%)  24/295 (8.14%) 
Weight Decreased † 1  15/298 (5.03%)  13/295 (4.41%) 
Metabolism and nutrition disorders     
Decreased Appetite † 1  44/298 (14.77%)  37/295 (12.54%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1  35/298 (11.74%)  37/295 (12.54%) 
Arthralgia † 1  31/298 (10.40%)  32/295 (10.85%) 
Pain In Extremity † 1  22/298 (7.38%)  23/295 (7.80%) 
Musculoskeletal Pain † 1  15/298 (5.03%)  19/295 (6.44%) 
Myalgia † 1  12/298 (4.03%)  16/295 (5.42%) 
Nervous system disorders     
Headache † 1  92/298 (30.87%)  37/295 (12.54%) 
Hypoaesthesia † 1  17/298 (5.70%)  8/295 (2.71%) 
Dizziness † 1  14/298 (4.70%)  16/295 (5.42%) 
Dysgeusia † 1  11/298 (3.69%)  17/295 (5.76%) 
Psychiatric disorders     
Insomnia † 1  24/298 (8.05%)  19/295 (6.44%) 
Renal and urinary disorders     
Haematuria † 1  20/298 (6.71%)  19/295 (6.44%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion † 1  48/298 (16.11%)  9/295 (3.05%) 
Dyspnoea † 1  32/298 (10.74%)  20/295 (6.78%) 
Cough † 1  17/298 (5.70%)  17/295 (5.76%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  24/298 (8.05%)  19/295 (6.44%) 
Vascular disorders     
Hypertension † 1  11/298 (3.69%)  19/295 (6.44%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[Not Specified]
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.
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 the filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00554229    
Obsolete Identifiers: NCT00707395
Other Study ID Numbers: D4320C00014
2007-003227-20 ( EudraCT Number )
First Submitted: November 2, 2007
First Posted: November 6, 2007
Results First Submitted: April 26, 2012
Results First Posted: May 31, 2012
Last Update Posted: February 8, 2016