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Trial Outcomes & Findings for A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (NCT NCT00554229)

NCT ID: NCT00554229

Last Updated: 2016-02-08

Results Overview

Median time (in months) from randomisation until death using the Kaplan-Meier method

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

896 participants

Primary outcome timeframe

From date of randomization until date of death, assessed up to 32 months

Results posted on

2016-02-08

Participant Flow

896 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 20th November 2007 and 13th February 2009.

302 of the 896 enrolled patients were not randomised to treatments groups as they failed screening.

Participant milestones

Participant milestones
Measure
ZD4054
ZD4054 10 mg oral tablet once daily
Placebo
Placebo oral tablet once daily
Overall Study
STARTED
299
295
Overall Study
Patients Who Received Treatment
298
295
Overall Study
COMPLETED
73
70
Overall Study
NOT COMPLETED
226
225

Reasons for withdrawal

Reasons for withdrawal
Measure
ZD4054
ZD4054 10 mg oral tablet once daily
Placebo
Placebo oral tablet once daily
Overall Study
Lost to Follow-up
3
6
Overall Study
Withdrawal by Subject
29
37
Overall Study
Adverse Event
71
39
Overall Study
Protocol Violation
3
3
Overall Study
Reason not otherwise captured, eg; death
119
140
Overall Study
Randomised but no treatment received
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Total
n=594 Participants
Total of all reporting groups
Age, Continuous
Overall
70.2 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
70.9 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
70.5 Years
STANDARD_DEVIATION 8.2 • 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
299 Participants
n=5 Participants
295 Participants
n=7 Participants
594 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of death, assessed up to 32 months

Median time (in months) from randomisation until death using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Overall Survival
24.5 months
Interval 0.5 to 31.2
22.5 months
Interval 0.5 to 29.8

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Progression Free Survival
6.2 Months
Interval 2.8 to 13.8
6.5 Months
Interval 2.8 to 13.2

SECONDARY outcome

Timeframe: From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months

Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Time to Use of Opiates
16.7 Months
Interval 7.3 to 27.0
14.8 Months
Interval 7.9 to 25.8

SECONDARY outcome

Timeframe: From date of randomization until occurrence of a skeletal related event, assessed up to 31 months

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.

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Incidence of Skeletal Related Events
18.4 Months
Interval 9.6 to 30.6
17.1 Months
Interval 9.3 to 25.8

SECONDARY outcome

Timeframe: Patients were assessed every 12 weeks

Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Bone Metastases Formation
15.1 Months
Interval 7.2 to 25.5
11.9 Months
Interval 7.0 to 22.5

SECONDARY outcome

Timeframe: Patients were assessed at every visit

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.

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Health Related Quality of Life
5.5 Months
Interval 2.8 to 9.1
5.5 Months
Interval 2.8 to 9.1

SECONDARY outcome

Timeframe: Patients were assessed every 12 weeks

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.

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Time to Prostate-specific Antigen (PSA) Progression
5.6 Months
Interval 2.9 to 11.1
5.6 Months
Interval 2.8 to 11.4

SECONDARY outcome

Timeframe: Patients were assessed every 12 weeks

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.

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Time to Pain Progression
9.0 Months
Interval 3.3 to 19.4
8.4 Months
Interval 3.4 to 19.1

SECONDARY outcome

Timeframe: Patients were assessed every 12 weeks

Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure
ZD4054
n=299 Participants
ZD4054 10 mg oral tablet once daily
Placebo
n=295 Participants
Placebo oral tablet once daily
Time to Initiation of Chemotherapy
11.4 Months
Interval 5.8 to 18.5
10.6 Months
Interval 6.0 to 18.2

SECONDARY outcome

Timeframe: PK samples were performed at randomisation, Week 4, Week 8 and Week 12

Outcome measures

Outcome data not reported

Adverse Events

ZD4054

Serious events: 98 serious events
Other events: 257 other events
Deaths: 0 deaths

Placebo

Serious events: 105 serious events
Other events: 221 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ZD4054
n=298 participants at risk
ZD4054 10 mg oral tablet once daily
Placebo
n=295 participants at risk
Placebo oral tablet once daily
Blood and lymphatic system disorders
Neutropenia
0.67%
2/298
1.0%
3/295
Blood and lymphatic system disorders
Bone Marrow Failure
0.00%
0/298
0.34%
1/295
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
0.00%
0/298
0.34%
1/295
Blood and lymphatic system disorders
Leukopenia
0.00%
0/298
0.34%
1/295
Blood and lymphatic system disorders
Thrombocytopenia
0.34%
1/298
0.34%
1/295
Cardiac disorders
Cardiac Failure
2.0%
6/298
0.00%
0/295
Cardiac disorders
Myocardial Infarction
1.0%
3/298
0.68%
2/295
Cardiac disorders
Acute Myocardial Infarction
0.67%
2/298
0.00%
0/295
Cardiac disorders
Left Ventricular Failure
0.00%
0/298
0.34%
1/295
Cardiac disorders
Angina Unstable
0.34%
1/298
0.00%
0/295
Cardiac disorders
Atrial Fibrillation
0.34%
1/298
0.34%
1/295
Nervous system disorders
Cerebrovascular Accident
1.0%
3/298
0.68%
2/295
Nervous system disorders
Transient Ischaemic Attack
0.00%
0/298
0.68%
2/295
Nervous system disorders
Cerebral Haemorrhage
0.34%
1/298
0.00%
0/295
Cardiac disorders
Atrial Flutter
0.34%
1/298
0.34%
1/295
Cardiac disorders
Atrioventricular Block
0.34%
1/298
0.00%
0/295
Cardiac disorders
Atrioventricular Block Complete
0.00%
0/298
0.34%
1/295
Cardiac disorders
Cardiac Failure Acute
0.00%
0/298
0.34%
1/295
Cardiac disorders
Cardiac Failure Congestive
0.34%
1/298
0.00%
0/295
Cardiac disorders
Cardio-Respiratory Arrest
0.34%
1/298
0.00%
0/295
Cardiac disorders
Coronary Artery Stenosis
0.00%
0/298
0.34%
1/295
Cardiac disorders
Myocardial Ischaemia
0.00%
0/298
0.34%
1/295
Cardiac disorders
Prinzmetal Angina
0.34%
1/298
0.00%
0/295
Cardiac disorders
Right Ventricular Failure
0.34%
1/298
0.00%
0/295
Cardiac disorders
Sick Sinus Syndrome
0.00%
0/298
0.34%
1/295
Cardiac disorders
Supraventricular Tachycardia
0.34%
1/298
0.00%
0/295
Cardiac disorders
Ventricular Tachycardia
0.34%
1/298
0.00%
0/295
Ear and labyrinth disorders
Sudden Hearing Loss
0.34%
1/298
0.00%
0/295
Eye disorders
Cataract
0.34%
1/298
0.00%
0/295
Eye disorders
Retinal Detachment
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Constipation
1.0%
3/298
0.34%
1/295
Gastrointestinal disorders
Diarrhoea
0.00%
0/298
0.68%
2/295
Gastrointestinal disorders
Abdominal Hernia
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Abdominal Pain
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Ascites
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Colitis Ulcerative
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Colonic Polyp
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Duodenal Ulcer Perforation
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Erosive Oesophagitis
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Gastric Haemorrhage
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Gastric Ulcer
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Gastritis Haemorrhagic
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Haematemesis
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Melaena
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Nausea
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Pancreatitis
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Pancreatitis Acute
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Peptic Ulcer Perforation
0.00%
0/298
0.34%
1/295
Gastrointestinal disorders
Retroperitoneal Haemorrhage
0.34%
1/298
0.00%
0/295
Gastrointestinal disorders
Vomiting
0.34%
1/298
0.34%
1/295
General disorders
Death
0.67%
2/298
2.4%
7/295
General disorders
Pyrexia
1.0%
3/298
0.68%
2/295
General disorders
Disease Progression
0.34%
1/298
0.68%
2/295
General disorders
Oedema Peripheral
0.67%
2/298
0.00%
0/295
General disorders
Asthenia
0.00%
0/298
0.34%
1/295
General disorders
Chest Discomfort
0.00%
0/298
0.34%
1/295
Nervous system disorders
Cerebral Infarction
0.00%
0/298
0.34%
1/295
Nervous system disorders
Cerebral Ischaemia
0.00%
0/298
0.34%
1/295
Nervous system disorders
Cerebral Thrombosis
0.34%
1/298
0.00%
0/295
Nervous system disorders
Cerebrovascular Disorder
0.34%
1/298
0.00%
0/295
Nervous system disorders
Convulsion
0.00%
0/298
0.34%
1/295
Nervous system disorders
Headache
0.34%
1/298
0.00%
0/295
General disorders
Chest Pain
0.34%
1/298
0.00%
0/295
Nervous system disorders
Lethargy
0.00%
0/298
0.34%
1/295
Nervous system disorders
Loss Of Consciousness
0.34%
1/298
0.00%
0/295
Nervous system disorders
Neuropathy Peripheral
0.34%
1/298
0.00%
0/295
Nervous system disorders
Paraesthesia
0.00%
0/298
0.34%
1/295
Nervous system disorders
Spinal Cord Compression
0.34%
1/298
0.34%
1/295
Nervous system disorders
Trigeminal Neuralgia
0.00%
0/298
0.34%
1/295
Nervous system disorders
Vith Nerve Paralysis
0.00%
0/298
0.34%
1/295
General disorders
Fatigue
0.00%
0/298
0.34%
1/295
General disorders
General Physical Health Deterioration
0.34%
1/298
0.00%
0/295
General disorders
Malaise
0.34%
1/298
0.00%
0/295
General disorders
Multi-Organ Failure
0.34%
1/298
0.00%
0/295
General disorders
Non-Cardiac Chest Pain
0.34%
1/298
0.34%
1/295
Hepatobiliary disorders
Cholecystitis
0.00%
0/298
0.68%
2/295
Hepatobiliary disorders
Bile Duct Obstruction
0.00%
0/298
0.34%
1/295
Hepatobiliary disorders
Bile Duct Stone
0.34%
1/298
0.00%
0/295
Hepatobiliary disorders
Cholangitis
0.34%
1/298
0.00%
0/295
Infections and infestations
Pneumonia
2.0%
6/298
0.34%
1/295
Infections and infestations
Sepsis
1.0%
3/298
1.0%
3/295
Infections and infestations
Bronchopneumonia
0.67%
2/298
0.00%
0/295
Infections and infestations
Respiratory Tract Infection
0.00%
0/298
0.68%
2/295
Infections and infestations
Septic Shock
0.00%
0/298
0.68%
2/295
Infections and infestations
Abscess Jaw
0.00%
0/298
0.34%
1/295
Infections and infestations
Appendicitis
0.34%
1/298
0.00%
0/295
Infections and infestations
Bronchitis
0.34%
1/298
0.00%
0/295
Infections and infestations
Cellulitis
0.34%
1/298
0.00%
0/295
Infections and infestations
Gastroenteritis
0.00%
0/298
0.34%
1/295
Infections and infestations
Infected Cyst
0.34%
1/298
0.00%
0/295
Infections and infestations
Lower Respiratory Tract Infection
0.00%
0/298
0.34%
1/295
Psychiatric disorders
Completed Suicide
0.00%
0/298
0.34%
1/295
Psychiatric disorders
Delirium
0.00%
0/298
0.34%
1/295
Psychiatric disorders
Suicide Attempt
0.00%
0/298
0.34%
1/295
Infections and infestations
Lung Infection
0.00%
0/298
0.34%
1/295
Infections and infestations
Meningitis
0.34%
1/298
0.34%
1/295
Infections and infestations
Necrotising Fasciitis
0.34%
1/298
0.00%
0/295
Infections and infestations
Oesophageal Candidiasis
0.00%
0/298
0.34%
1/295
Infections and infestations
Post Procedural Infection
0.00%
0/298
0.34%
1/295
Infections and infestations
Staphylococcal Infection
0.00%
0/298
0.34%
1/295
Infections and infestations
Urinary Tract Infection
0.34%
1/298
0.34%
1/295
Infections and infestations
Urosepsis
0.34%
1/298
0.00%
0/295
Infections and infestations
Viral Pericarditis
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Hip Fracture
0.00%
0/298
0.68%
2/295
Injury, poisoning and procedural complications
Subdural Haematoma
0.67%
2/298
0.34%
1/295
Injury, poisoning and procedural complications
Cerebral Haemorrhage Traumatic
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
0.34%
1/298
0.34%
1/295
Injury, poisoning and procedural complications
Cystitis Radiation
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Femoral Neck Fracture
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Fibula Fracture
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Splenic Rupture
0.34%
1/298
0.00%
0/295
Injury, poisoning and procedural complications
Subcutaneous Haematoma
0.00%
0/298
0.34%
1/295
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
0.34%
1/298
0.00%
0/295
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/298
0.68%
2/295
Metabolism and nutrition disorders
Decreased Appetite
0.34%
1/298
0.34%
1/295
Metabolism and nutrition disorders
Dehydration
0.34%
1/298
0.34%
1/295
Metabolism and nutrition disorders
Diabetes Mellitus
0.00%
0/298
0.34%
1/295
Metabolism and nutrition disorders
Gout
0.34%
1/298
0.00%
0/295
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/298
0.68%
2/295
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/298
0.34%
1/295
Renal and urinary disorders
Renal Failure Acute
0.34%
1/298
1.4%
4/295
Renal and urinary disorders
Urinary Retention
1.0%
3/298
0.00%
0/295
Renal and urinary disorders
Renal Failure
0.34%
1/298
0.68%
2/295
Renal and urinary disorders
Anuria
0.00%
0/298
0.34%
1/295
Renal and urinary disorders
Haematuria
0.00%
0/298
0.34%
1/295
Renal and urinary disorders
Haemorrhage Urinary Tract
0.00%
0/298
0.34%
1/295
Renal and urinary disorders
Hydronephrosis
0.34%
1/298
0.34%
1/295
Renal and urinary disorders
Urethral Stenosis
0.00%
0/298
0.34%
1/295
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
0.34%
1/298
0.00%
0/295
Reproductive system and breast disorders
Priapism
0.00%
0/298
0.34%
1/295
Reproductive system and breast disorders
Prostatic Haemorrhage
0.34%
1/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
1.7%
5/298
0.68%
2/295
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
1.3%
4/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
0.00%
0/298
1.0%
3/295
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
0.00%
0/298
1.0%
3/295
Respiratory, thoracic and mediastinal disorders
Asthma
0.34%
1/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.67%
2/298
0.68%
2/295
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
0.67%
2/298
0.34%
1/295
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.34%
1/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Hydrothorax
0.34%
1/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
0.00%
0/298
0.34%
1/295
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
0.00%
0/298
0.34%
1/295
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
0.34%
1/298
0.00%
0/295
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.34%
1/298
0.34%
1/295
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
0.34%
1/298
0.00%
0/295
Skin and subcutaneous tissue disorders
Decubitus Ulcer
0.00%
0/298
0.34%
1/295
Vascular disorders
Deep Vein Thrombosis
0.34%
1/298
0.68%
2/295
Vascular disorders
Aortic Dissection
0.00%
0/298
0.34%
1/295
Vascular disorders
Arteriosclerosis
0.00%
0/298
0.34%
1/295
Vascular disorders
Haematoma
0.34%
1/298
0.34%
1/295
Vascular disorders
Iliac Artery Occlusion
0.00%
0/298
0.34%
1/295
Vascular disorders
Lymphoedema
0.34%
1/298
0.00%
0/295
Vascular disorders
Phlebitis
0.00%
0/298
0.34%
1/295
Vascular disorders
Venous Thrombosis Limb
0.00%
0/298
0.34%
1/295
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/298
0.34%
1/295
Musculoskeletal and connective tissue disorders
Osteonecrosis Of Jaw
0.34%
1/298
0.00%
0/295
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.00%
0/298
0.34%
1/295
Musculoskeletal and connective tissue disorders
Pathological Fracture
0.34%
1/298
0.00%
0/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
0.34%
1/298
0.34%
1/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
0.34%
1/298
0.00%
0/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
0.34%
1/298
0.00%
0/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
0.00%
0/298
0.34%
1/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
0.00%
0/298
0.34%
1/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Spine
0.00%
0/298
0.34%
1/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
0.34%
1/298
0.00%
0/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
0.34%
1/298
0.00%
0/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Neoplasm
0.34%
1/298
0.00%
0/295
Blood and lymphatic system disorders
Anaemia
2.0%
6/298
0.34%
1/295
Blood and lymphatic system disorders
Febrile Neutropenia
0.67%
2/298
1.0%
3/295

Other adverse events

Other adverse events
Measure
ZD4054
n=298 participants at risk
ZD4054 10 mg oral tablet once daily
Placebo
n=295 participants at risk
Placebo oral tablet once daily
Blood and lymphatic system disorders
Anaemia
15.4%
46/298
11.2%
33/295
Blood and lymphatic system disorders
Neutropenia
3.7%
11/298
5.4%
16/295
Gastrointestinal disorders
Nausea
20.8%
62/298
14.9%
44/295
Gastrointestinal disorders
Constipation
20.5%
61/298
17.3%
51/295
Gastrointestinal disorders
Diarrhoea
9.4%
28/298
15.6%
46/295
Gastrointestinal disorders
Vomiting
11.4%
34/298
7.8%
23/295
General disorders
Oedema Peripheral
44.3%
132/298
19.0%
56/295
General disorders
Fatigue
19.5%
58/298
17.6%
52/295
General disorders
Pyrexia
10.1%
30/298
7.5%
22/295
General disorders
Asthenia
6.0%
18/298
7.5%
22/295
Infections and infestations
Rhinitis
11.7%
35/298
4.4%
13/295
Infections and infestations
Nasopharyngitis
9.4%
28/298
8.5%
25/295
Infections and infestations
Urinary Tract Infection
6.4%
19/298
8.1%
24/295
Infections and infestations
Weight Decreased
5.0%
15/298
4.4%
13/295
Metabolism and nutrition disorders
Decreased Appetite
14.8%
44/298
12.5%
37/295
Musculoskeletal and connective tissue disorders
Back Pain
11.7%
35/298
12.5%
37/295
Musculoskeletal and connective tissue disorders
Arthralgia
10.4%
31/298
10.8%
32/295
Musculoskeletal and connective tissue disorders
Pain In Extremity
7.4%
22/298
7.8%
23/295
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
5.0%
15/298
6.4%
19/295
Musculoskeletal and connective tissue disorders
Myalgia
4.0%
12/298
5.4%
16/295
Nervous system disorders
Headache
30.9%
92/298
12.5%
37/295
Nervous system disorders
Hypoaesthesia
5.7%
17/298
2.7%
8/295
Nervous system disorders
Dizziness
4.7%
14/298
5.4%
16/295
Nervous system disorders
Dysgeusia
3.7%
11/298
5.8%
17/295
Psychiatric disorders
Insomnia
8.1%
24/298
6.4%
19/295
Renal and urinary disorders
Haematuria
6.7%
20/298
6.4%
19/295
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
16.1%
48/298
3.1%
9/295
Respiratory, thoracic and mediastinal disorders
Dyspnoea
10.7%
32/298
6.8%
20/295
Respiratory, thoracic and mediastinal disorders
Cough
5.7%
17/298
5.8%
17/295
Skin and subcutaneous tissue disorders
Alopecia
8.1%
24/298
6.4%
19/295
Vascular disorders
Hypertension
3.7%
11/298
6.4%
19/295

Additional Information

Gerard Lynch

AstraZeneca

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER