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Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

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ClinicalTrials.gov Identifier: NCT02987543
Recruitment Status : Active, not recruiting
First Posted : December 9, 2016
Results First Posted : October 12, 2020
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Foundation Medicine, Inc.
Myriad Genetics, Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Castration-resistant Prostate Cancer
Interventions Drug: olaparib
Drug: enzalutamide
Drug: abiraterone acetate
Enrollment 387
Recruitment Details Subjects were divided into two cohorts based on HRR gene mutation status. Subjects with mutations in either BRCA1, BRCA2, or ATM are in Cohort A whereas subjects with mutations among 12 other genes involved in the HRR pathway (BARD1, BRIP1, CDK12, CHEK1,CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L) are in Cohort B.
Pre-assignment Details  
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA Cohort B Olaparib 300mg bd Cohort B Investigators Choice of NHA
Hide Arm/Group Description 2x150mg film-coated tablets either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) 2x150mg film-coated tablets either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Period Title: Overall Study
Started 162 83 94 48
Completed 0 0 0 0
Not Completed 162 83 94 48
Reason Not Completed
Ongoing study at data cut off             49             21             19             12
Death             88             54             67             28
Lost to Follow-up             3             0             1             0
Screen failure             0             0             0             1
Withdrawal by Subject             21             7             7             6
Study terminated by sponsor             1             0             0             0
Investigator decision             0             1             0             0
Disease progression             0             0             0             1
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA Cohort B Olaparib 300mg bd Cohort B Investigators Choice of NHA Total
Hide Arm/Group Description 2x150mg film-coated tablets either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) 2x150mg film-coated tablets either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) Total of all reporting groups
Overall Number of Baseline Participants 162 83 94 48 387
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 83 participants 94 participants 48 participants 387 participants
68.0  (8.23) 68.1  (7.36) 69.2  (8.79) 70.3  (7.83) 68.6  (8.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 83 participants 94 participants 48 participants 387 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
162
 100.0%
83
 100.0%
94
 100.0%
48
 100.0%
387
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants 83 participants 94 participants 48 participants 387 participants
White 109 55 54 30 248
Black or African American 2 1 5 0 8
Asian 43 19 26 17 105
Other 1 1 1 0 3
Missing 7 7 8 1 23
1.Primary Outcome
Title Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only
Hide Description The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline).
Time Frame Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA
Hide Arm/Group Description:
2x150mg film-coated tablets
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Overall Number of Participants Analyzed 162 83
Median (95% Confidence Interval)
Unit of Measure: Months
7.39
(6.24 to 9.33)
3.55
(1.91 to 3.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A Olaparib 300mg bd, Cohort A Investigators Choice of NHA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.25 to 0.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only
Hide Description ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.
Time Frame Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA
Hide Arm/Group Description:
2x150mg film-coated tablets
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Overall Number of Participants Analyzed 84 43
Measure Type: Count of Participants
Unit of Measure: Participants
Response
28
  33.3%
1
   2.3%
No response
56
  66.7%
42
  97.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A Olaparib 300mg bd, Cohort A Investigators Choice of NHA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 20.86
Confidence Interval (2-Sided) 95%
4.18 to 379.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B
Hide Description The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Time Frame Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA
Hide Arm/Group Description:
2x150mg film-coated tablets
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Overall Number of Participants Analyzed 256 131
Median (95% Confidence Interval)
Unit of Measure: Months
5.82
(5.52 to 7.36)
3.52
(2.2 to 3.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A Olaparib 300mg bd, Cohort A Investigators Choice of NHA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.38 to 0.63
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Pain Progression - Cohort A Only
Hide Description Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score.
Time Frame Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA
Hide Arm/Group Description:
2x150mg film-coated tablets
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Overall Number of Participants Analyzed 162 83
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
9.92 [1] 
(5.39 to NA)
[1]
NA - Not calculated, estimates cannot be calculated due to too few events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A Olaparib 300mg bd, Cohort A Investigators Choice of NHA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0192
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.22 to 0.91
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival (OS) - Cohort A Only
Hide Description Number of Participants with Overall Survival (OS) - Cohort A only.
Time Frame Approximately 35 months after the first patient was randomised.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Cohort A Olaparib 300mg bd Cohort A Investigators Choice of NHA
Hide Arm/Group Description:
2x150mg film-coated tablets
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
Overall Number of Participants Analyzed 162 83
Measure Type: Count of Participants
Unit of Measure: Participants
Died
91
  56.2%
57
  68.7%
Alive at data cut-off
49
  30.2%
21
  25.3%
Terminated prior to death (withdrawn consent)
22
  13.6%
5
   6.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A Olaparib 300mg bd, Cohort A Investigators Choice of NHA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0175
Comments 2-sided p-value
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.50 to 0.97
Estimation Comments [Not Specified]
Time Frame From the time of signature of informed consent throughout the treatment period (median duration of treatment of 7.5 and 3.9 months for Olaparib and Investigators Choice of NHA respectively) up to and including the 30-day follow-up period
Adverse Event Reporting Description There were 131 subjects randomised to the Investigators Choice of NHA treatment group (Full Analysis Set), however 1 of these subjects did not receive treatment (resulting in 130 in the Safety Analysis Set). Hence, for the Investigators Choice of NHA, the Total number at risk for all-cause mortality = 131 while the Total # at Risk by any Serious Adverse Event = 130 and the Total # at Risk by any Other Adverse Event = 130.
 
Arm/Group Title Cohort A+B Olaparib 300mg bd Cohort A+B Investigators Choice of NHA
Hide Arm/Group Description 2x150mg film-coated tablets either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
All-Cause Mortality
Cohort A+B Olaparib 300mg bd Cohort A+B Investigators Choice of NHA
Affected / at Risk (%) Affected / at Risk (%)
Total   160/256 (62.50%)      88/131 (67.18%)    
Hide Serious Adverse Events
Cohort A+B Olaparib 300mg bd Cohort A+B Investigators Choice of NHA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/256 (36.72%)      39/130 (30.00%)    
Blood and lymphatic system disorders     
Anaemia  1  23/256 (8.98%)  24 0/130 (0.00%)  0
Febrile neutropenia  1  1/256 (0.39%)  1 1/130 (0.77%)  1
Neutropenia  1  3/256 (1.17%)  3 0/130 (0.00%)  0
Pancytopenia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Thrombocytopenia  1  4/256 (1.56%)  6 0/130 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Angina pectoris  1  1/256 (0.39%)  1 2/130 (1.54%)  2
Atrial fibrillation  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cardiac failure  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Cardiac failure acute  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cardiomyopathy  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Cardiopulmonary failure  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Coronary ostial stenosis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Myocardial infarction  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Right ventricular failure  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Coronary artery stenosis  2  0/256 (0.00%)  0 1/130 (0.77%)  1
Endocrine disorders     
Adrenal insufficiency  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Eye disorders     
Diplopia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Diarrhoea  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Diverticulum intestinal  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Gastric perforation  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Gastric ulcer  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Gastric ulcer haemorrhage  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Inguinal hernia  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Nausea  1  2/256 (0.78%)  2 2/130 (1.54%)  2
Obstruction gastric  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Obstructive pancreatitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Small intestinal obstruction  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Stress ulcer  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Vomiting  1  4/256 (1.56%)  4 1/130 (0.77%)  1
Duodenal ulcer perforation  2  0/256 (0.00%)  0 1/130 (0.77%)  1
General disorders     
Asthenia  1  4/256 (1.56%)  4 1/130 (0.77%)  1
Death  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Fatigue  1  2/256 (0.78%)  2 0/130 (0.00%)  0
General physical health deterioration  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Pain  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Pyrexia  1  3/256 (1.17%)  3 2/130 (1.54%)  3
Sudden death  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Hepatobiliary disorders     
Budd-Chiari syndrome  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cholangitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cholecystitis acute  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Infections and infestations     
Anal abscess  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Cellulitis of male external genital organ  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cystitis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Gastroenteritis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Infection  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Nasopharyngitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Neutropenic sepsis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Pharyngitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Pneumonia  1  11/256 (4.30%)  13 4/130 (3.08%)  4
Pyelonephritis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Sepsis  1  3/256 (1.17%)  3 3/130 (2.31%)  3
Septic shock  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Urinary tract infection  1  5/256 (1.95%)  6 4/130 (3.08%)  4
Urosepsis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Pneumocystis jirovecii pneumoni  2  1/256 (0.39%)  1 0/130 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Concussion  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cystitis radiation  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Fall  1  1/256 (0.39%)  1 2/130 (1.54%)  2
Femur fracture  1  3/256 (1.17%)  3 0/130 (0.00%)  0
Fracture  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Gastroenteritis radiation  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Post-traumatic pain  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Spinal compression fracture  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Spinal fracture  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Subdural haematoma  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Dehydration  1  0/256 (0.00%)  0 3/130 (2.31%)  3
Hypocalcaemia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Hypoglycaemia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Hyponatraemia  1  2/256 (0.78%)  3 0/130 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Back pain  1  1/256 (0.39%)  1 1/130 (0.77%)  1
Bone pain  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Muscular weakness  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Musculoskeletal chest pain  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Musculoskeletal pain  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Spinal stenosis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Glioma  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Transitional cell carcinoma  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Nervous system disorders     
Ballismus  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Cerebral infarction  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Cerebrovascular accident  1  3/256 (1.17%)  3 0/130 (0.00%)  0
Dizziness  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Ischaemic stroke  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Neuralgia  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Spinal cord compression  1  1/256 (0.39%)  1 1/130 (0.77%)  1
Syncope  2  1/256 (0.39%)  1 0/130 (0.00%)  0
Psychiatric disorders     
Confusional state  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Delirium  1  1/256 (0.39%)  1 2/130 (1.54%)  2
Renal and urinary disorders     
Acute kidney injury  1  1/256 (0.39%)  1 2/130 (1.54%)  2
Calculus bladder  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Chronic kidney disease  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Haematuria  1  3/256 (1.17%)  3 1/130 (0.77%)  1
Hydronephrosis  1  1/256 (0.39%)  1 1/130 (0.77%)  1
Nephrolithiasis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Renal failure  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Renal impairment  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Urinary retention  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Urinary tract obstruction  1  0/256 (0.00%)  0 2/130 (1.54%)  2
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/256 (0.39%)  2 0/130 (0.00%)  0
Dyspnoea  1  4/256 (1.56%)  4 1/130 (0.77%)  1
Interstitial lung disease  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Pleural effusion  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Pneumonia aspiration  1  3/256 (1.17%)  3 0/130 (0.00%)  0
Pneumonitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Pneumothorax  1  2/256 (0.78%)  2 0/130 (0.00%)  0
Pulmonary embolism  1  5/256 (1.95%)  5 1/130 (0.77%)  1
Respiratory failure  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Skin ulcer  2  1/256 (0.39%)  1 0/130 (0.00%)  0
Vascular disorders     
Arterial thrombosis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Deep vein thrombosis  1  0/256 (0.00%)  0 1/130 (0.77%)  1
Embolism  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Orthostatic hypotension  1  1/256 (0.39%)  1 0/130 (0.00%)  0
Phlebitis  1  1/256 (0.39%)  1 0/130 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
2
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A+B Olaparib 300mg bd Cohort A+B Investigators Choice of NHA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   241/256 (94.14%)      112/130 (86.15%)    
Blood and lymphatic system disorders     
Anaemia  1  110/256 (42.97%)  154 20/130 (15.38%)  23
Lymphopenia  1  13/256 (5.08%)  15 1/130 (0.77%)  1
Neutropenia  1  13/256 (5.08%)  16 0/130 (0.00%)  0
Thrombocytopenia  1  18/256 (7.03%)  22 2/130 (1.54%)  2
Gastrointestinal disorders     
Constipation  1  49/256 (19.14%)  52 19/130 (14.62%)  21
Diarrhoea  1  54/256 (21.09%)  71 9/130 (6.92%)  9
Dyspepsia  1  20/256 (7.81%)  23 3/130 (2.31%)  3
Nausea  1  109/256 (42.58%)  136 26/130 (20.00%)  28
Vomiting  1  49/256 (19.14%)  82 17/130 (13.08%)  19
Stomatitis  2  13/256 (5.08%)  14 2/130 (1.54%)  2
General disorders     
Asthenia  1  37/256 (14.45%)  54 18/130 (13.85%)  19
Fatigue  1  68/256 (26.56%)  71 28/130 (21.54%)  28
Oedema peripheral  1  34/256 (13.28%)  36 10/130 (7.69%)  10
Pyrexia  1  15/256 (5.86%)  16 4/130 (3.08%)  4
Infections and infestations     
Urinary tract infection  1  18/256 (7.03%)  22 12/130 (9.23%)  15
Investigations     
Weight decreased  1  21/256 (8.20%)  21 7/130 (5.38%)  7
Metabolism and nutrition disorders     
Decreased appetite  1  78/256 (30.47%)  88 24/130 (18.46%)  25
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/256 (9.77%)  26 14/130 (10.77%)  16
Back pain  1  36/256 (14.06%)  44 17/130 (13.08%)  18
Musculoskeletal chest pain  1  14/256 (5.47%)  14 6/130 (4.62%)  7
Musculoskeletal pain  1  17/256 (6.64%)  18 6/130 (4.62%)  6
Pain in extremity  2  14/256 (5.47%)  18 6/130 (4.62%)  6
Nervous system disorders     
Dizziness  1  17/256 (6.64%)  18 5/130 (3.85%)  5
Dysgeusia  1  18/256 (7.03%)  20 2/130 (1.54%)  2
Headache  1  16/256 (6.25%)  29 3/130 (2.31%)  3
Psychiatric disorders     
Insomnia  1  14/256 (5.47%)  14 4/130 (3.08%)  4
Renal and urinary disorders     
Haematuria  1  6/256 (2.34%)  7 10/130 (7.69%)  11
Respiratory, thoracic and mediastinal disorders     
Cough  1  29/256 (11.33%)  32 3/130 (2.31%)  3
Dyspnoea  1  24/256 (9.38%)  25 4/130 (3.08%)  4
1
Term from vocabulary, MedDRA 22.0
2
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02987543    
Other Study ID Numbers: D081DC00007
First Submitted: November 15, 2016
First Posted: December 9, 2016
Results First Submitted: June 3, 2020
Results First Posted: October 12, 2020
Last Update Posted: February 25, 2021