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Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

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: NCT03732820
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Results First Posted : June 15, 2023
Last Update Posted : February 28, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
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 Metastatic Castration-resistant Prostate Cancer
Interventions Drug: olaparib
Drug: abiraterone acetate
Enrollment 895
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Period Title: Overall Study
Started 399 397
Completed 0 0
Not Completed 399 397
Reason Not Completed
Death             168             203
Other             2             2
Failure to meet randomisation criteria             1             1
Patient decision             14             10
Screen failure             0             1
Patients ongoing study at data cut off             210             178
Lost to Follow-up             4             2
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd Total
Hide Arm/Group Description Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily. Total of all reporting groups
Overall Number of Baseline Participants 399 397 796
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 399 participants 397 participants 796 participants
68.5  (8.5) 69.8  (7.9) 69.1  (8.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 399 participants 397 participants 796 participants
>=65 269 300 569
<65 130 97 227
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 399 participants 397 participants 796 participants
399 397 796
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 399 participants 397 participants 796 participants
HISPANIC OR LATINO 68 63 131
NOT HISPANIC OR LATINO 310 305 615
NOT REPORTED 21 29 50
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 399 participants 397 participants 796 participants
AMERICAN INDIAN OR ALASKA NATIVE 1 0 1
ASIAN 66 72 138
BLACK OR AFRICAN AMERICAN 14 11 25
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 2 0 2
NOT REPORTED 22 30 52
UNKNOWN 12 9 21
WHITE 282 275 557
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 399 participants 397 participants 796 participants
USA 40 34 74
Turkey 39 33 72
Slovakia 5 13 18
Netherlands 16 12 28
Korea, Republic Of 27 29 56
Japan 36 41 77
Italy 22 18 40
United Kingdom 27 22 49
France 14 25 39
Spain 19 24 43
Germany 14 11 25
Czech Republic 18 13 31
Chile 19 25 44
Canada 17 16 33
Brazil 54 46 100
Belgium 4 1 5
Australia 28 34 62
1.Primary Outcome
Title Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment
Hide Description

An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1] and/or Prostate Cancer Working Group 3 [PCWG-3] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression.

Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified.

Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.
Time Frame Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
168
  42.1%
226
  56.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.54 to 0.81
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
2.Secondary Outcome
Title Number of Participants With Overall Survival (OS) Event
Hide Description An OS event is defined as death by any cause, regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months). DCO3 is the final data cut-off for the OS analysis and therefore no further updates will be made.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
176
  44.1%
205
  51.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0544
Comments A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.67 to 1.00
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
3.Secondary Outcome
Title Number of Participants With Time to First Subsequent Anticancer Therapy or Death (TFST) Event
Hide Description A TFST (excluding radiotherapy) event is defined as the start of the first subsequent anticancer therapy after discontinuation of randomised treatment or death from any cause.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
255
  63.9%
285
  71.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.64 to 0.90
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
4.Secondary Outcome
Title Number of Participants With Time to Pain Progression (TTPP) Event
Hide Description A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm [AQA] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score >0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
68
  17.0%
60
  15.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7456
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.75 to 1.50
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
5.Secondary Outcome
Title Number of Participants With Opiate Use
Hide Description An event for opiate use is defined as the first opiate use for cancer related pain.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients who are not on opiates at baseline
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 344 353
Measure Type: Count of Participants
Unit of Measure: Participants
58
  16.9%
45
  12.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3099
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.82 to 1.79
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
6.Secondary Outcome
Title Number of Participants With First Symptomatic Skeletal Related Event (SSRE)
Hide Description

An SSRE event is defined as the first sympomatic skeletal-related event defined by

  • Use of radiation therapy to prevent or relieve skeletal symptoms.
  • Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
46
  11.5%
51
  12.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3212
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.55 to 1.22
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
7.Secondary Outcome
Title Number of Participants With Second Progression or Death (PFS2) Event
Hide Description An event for PFS2 is defined as the second progression on next-line anticancer therapy or death, whichever occurs earlier.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 399 397
Measure Type: Count of Participants
Unit of Measure: Participants
103
  25.8%
126
  31.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg bd + Abiraterone 1000 mg qd, Placebo bd + Abiraterone 1000 mg qd
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0534
Comments [Not Specified]
Method Log Rank
Comments Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.59 to 0.99
Estimation Comments HR and CI calculated using Cox Proportional Hazards model, where a HR < 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
8.Secondary Outcome
Title Brief Pain Inventory-Short Form (BPI-SF)
Hide Description The BPI-SF is a validated, 15-item domain-specific instrument designed to assess the severity of pain and the impact/interference of pain on daily functions. BPI-SF worst pain, pain severity and pain interference score changes can be a minimum of -10 and a maximum of 10. A negative change from baseline value indicates improvement.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 330 333
Least Squares Mean (Standard Error)
Unit of Measure: Score
Change from baseline in BPI-SF worst pain -0.09  (0.093) 0.03  (0.099)
Change from baseline in BPI-SF pain severity score -0.08  (0.071) -0.02  (0.076)
Change from baseline in BPI-SF pain interference score 0.01  (0.074) 0.13  (0.079)
9.Secondary Outcome
Title Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
Hide Description

Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) total score and Functional Assessment of Cancer Therapy-General (FACT-G) total score.

Total FACT-P score is the sum of Physical Well-being (PWB), Social Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) and Prostate cancer subscale (PCS). FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A positive value indicates improvement.

FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score change from baseline values can be a minimum of -108 and a maximum of 108. A positive value indicates improvement.
Time Frame Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description:
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
Overall Number of Participants Analyzed 278 295
Least Squares Mean (Standard Error)
Unit of Measure: Score
Change from baseline in FACT-P Total -5.84  (1.031) -5.30  (1.060)
Change from baseline in FACT-G Total -5.06  (0.766) -4.35  (0.787)
Time Frame Adverse events with an onset date, or worsen, on or after the date of first dose and up to and including 30 days following discontinuation of randomised treatment. Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Adverse Event Reporting Description Adverse events were assessed based on the Safety population consisting of patients who received treatment (N=794) while all-cause mortality was assessed based on all patients randomized (N=796).
 
Arm/Group Title Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Hide Arm/Group Description Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
All-Cause Mortality
Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Affected / at Risk (%) Affected / at Risk (%)
Total   176/399 (44.11%)      205/397 (51.64%)    
Hide Serious Adverse Events
Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/398 (40.45%)      126/396 (31.82%)    
Blood and lymphatic system disorders     
Anaemia † 1  23/398 (5.78%)  29 3/396 (0.76%)  3
Febrile neutropenia † 1  5/398 (1.26%)  5 2/396 (0.51%)  2
Leukocytosis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Myelosuppression † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Neutropenia † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Thrombocytopenia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction † 1  4/398 (1.01%)  5 3/396 (0.76%)  3
Angina pectoris † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Atrial fibrillation † 1  4/398 (1.01%)  6 4/396 (1.01%)  5
Atrioventricular block complete † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Cardiac failure † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Cardiac failure acute † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Coronary artery disease † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Left ventricular failure † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Mitral valve disease † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Myocardial infarction † 1  1/398 (0.25%)  1 3/396 (0.76%)  3
Myocardial ischaemia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Palpitations † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Prinzmetal angina † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Acute coronary syndrome † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Ear and labyrinth disorders     
Vertigo † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Vestibular disorder † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Eye disorders     
Cataract † 1  2/398 (0.50%)  3 2/396 (0.51%)  2
Limbal stem cell deficiency † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Gastrointestinal disorders     
Abdominal pain † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Colitis † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Colitis ulcerative † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Diarrhoea † 1  3/398 (0.75%)  3 0/396 (0.00%)  0
Duodenal ulcer † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Gastric ulcer perforation † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Gastroduodenal ulcer † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Gastrointestinal angiodysplasia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Haematochezia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hypoaesthesia oral † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Ileus † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Inguinal hernia † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Intestinal obstruction † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Intestinal ulcer † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Large intestine polyp † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Lower gastrointestinal haemorrhage † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Nausea † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Rectal haemorrhage † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Small intestinal obstruction † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Umbilical hernia, obstructive † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Vomiting † 1  4/398 (1.01%)  4 1/396 (0.25%)  1
General disorders     
Asthenia † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Death † 1  1/398 (0.25%)  1 4/396 (1.01%)  4
Fatigue † 1  3/398 (0.75%)  3 1/396 (0.25%)  1
General physical health deterioration † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Malaise † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Non-cardiac chest pain † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pyrexia † 1  3/398 (0.75%)  3 2/396 (0.51%)  2
Sudden death † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Cholangitis acute † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Cholecystitis † 1  2/398 (0.50%)  3 0/396 (0.00%)  0
Cholecystitis acute † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Drug-induced liver injury † 1  0/398 (0.00%)  0 2/396 (0.51%)  3
Portal vein thrombosis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Immune system disorders     
Anaphylactic shock † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Infections and infestations     
Urinary tract infection † 1  9/398 (2.26%)  17 3/396 (0.76%)  3
Urinary tract infection pseudomonal † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Urosepsis † 1  5/398 (1.26%)  5 2/396 (0.51%)  2
Wound infection staphylococcal † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Acute sinusitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Anal abscess † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Appendicitis † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Atypical pneumonia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Bacterial sepsis † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Covid-19 † 1  15/398 (3.77%)  16 10/396 (2.53%)  10
Covid-19 pneumonia † 1  7/398 (1.76%)  7 3/396 (0.76%)  3
Cellulitis † 1  1/398 (0.25%)  1 1/396 (0.25%)  2
Diverticulitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Gastroenteritis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Gastroenteritis viral † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Hepatitis b reactivation † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Infection † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Lower respiratory tract infection † 1  3/398 (0.75%)  3 0/396 (0.00%)  0
Lung abscess † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Oral infection † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Osteomyelitis † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Perirectal abscess † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pneumococcal sepsis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pneumocystis jirovecii pneumonia † 1  4/398 (1.01%)  4 0/396 (0.00%)  0
Pneumonia † 1  11/398 (2.76%)  13 5/396 (1.26%)  5
Pneumonia aspiration † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pneumonia bacterial † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Pneumonia cryptococcal † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Pneumonia viral † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Pyelonephritis † 1  0/398 (0.00%)  0 1/396 (0.25%)  2
Pyelonephritis acute † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Sepsis † 1  5/398 (1.26%)  5 3/396 (0.76%)  3
Septic shock † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Skin infection † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Staphylococcal sepsis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Suspected covid-19 † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Injury, poisoning and procedural complications     
Cervical vertebral fracture † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Craniocerebral injury † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Extra-axial haemorrhage † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Fall † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Femoral neck fracture † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Femur fracture † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Gun shot wound † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hand fracture † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Head injury † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hip fracture † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Injury † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Limb crushing injury † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Post procedural complication † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Post procedural haematoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Post procedural haemorrhage † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Post procedural hypotension † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Radiation pneumonitis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Radiation proctitis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Radius fracture † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Rib fracture † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Spinal fracture † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Sternal fracture † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Subdural haematoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Thermal burn † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Tibia fracture † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Toxicity to various agents † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Aspartate aminotransferase increased † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Blood creatinine increased † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Electrocardiogram qt prolonged † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Lymphocyte count decreased † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Neutrophil count decreased † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
White blood cell count decreased † 1  3/398 (0.75%)  3 0/396 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Dehydration † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Diabetes mellitus inadequate control † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Diabetic ketoacidosis † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Hyperglycaemia † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Hypoalbuminaemia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hypocalcaemia † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Hypokalaemia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hyponatraemia † 1  1/398 (0.25%)  1 2/396 (0.51%)  2
Hypophagia † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Musculoskeletal and connective tissue disorders     
Back pain † 1  5/398 (1.26%)  6 3/396 (0.76%)  3
Bone pain † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Intervertebral disc protrusion † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Muscular weakness † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Neck pain † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Osteitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Osteoarthritis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Osteonecrosis of jaw † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Osteoporosis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Osteoporotic fracture † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Spinal pain † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Colon cancer † 1  3/398 (0.75%)  3 1/396 (0.25%)  1
Colorectal adenoma † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Colorectal cancer † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Diffuse large b-cell lymphoma † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Gastric adenoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Gastric cancer † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Lung adenocarcinoma † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Malignant melanoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Myelodysplastic syndrome † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Neuroendocrine carcinoma of the skin † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Non-small cell lung cancer † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Penile squamous cell carcinoma † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pituitary tumour benign † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Plasma cell myeloma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Rectal cancer † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Small intestine adenocarcinoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Squamous cell carcinoma † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Squamous cell carcinoma of skin † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Squamous cell carcinoma of the tongue † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Transitional cell carcinoma † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Nervous system disorders     
Cerebral ischaemia † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Cerebrovascular accident † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Depressed level of consciousness † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Dizziness † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Embolic stroke † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Epilepsy † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hemiparesis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Hypoglycaemic unconsciousness † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Intraventricular haemorrhage † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Ischaemic stroke † 1  1/398 (0.25%)  1 4/396 (1.01%)  4
Loss of consciousness † 1  1/398 (0.25%)  1 2/396 (0.51%)  2
Neuralgia † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Optic neuritis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Partial seizures † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Syncope † 1  5/398 (1.26%)  5 2/396 (0.51%)  2
Thalamic infarction † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Transient ischaemic attack † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Product Issues     
Device occlusion † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Psychiatric disorders     
Alcohol withdrawal syndrome † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Depression † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Renal and urinary disorders     
Acute kidney injury † 1  3/398 (0.75%)  3 4/396 (1.01%)  4
Calculus bladder † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Dysuria † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Haematuria † 1  2/398 (0.50%)  2 1/396 (0.25%)  1
Hydronephrosis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Nephrolithiasis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Postrenal failure † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Ureteric obstruction † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Ureterolithiasis † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Urethral stenosis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Urinary incontinence † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Urinary retention † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Urinary tract obstruction † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Urinary tract pain † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1  0/398 (0.00%)  0 2/396 (0.51%)  2
Chronic obstructive pulmonary disease † 1  2/398 (0.50%)  3 0/396 (0.00%)  0
Dyspnoea † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Interstitial lung disease † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Nasal polyps † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Pneumonitis † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Pneumothorax † 1  1/398 (0.25%)  1 1/396 (0.25%)  1
Pulmonary embolism † 1  15/398 (3.77%)  15 3/396 (0.76%)  3
Respiratory failure † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cutaneous vasculitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Dermatitis † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Drug eruption † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Vascular disorders     
Adventitial cystic disease † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Aortic dissection † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Aortic stenosis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Deep vein thrombosis † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Giant cell arteritis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Hypotension † 1  0/398 (0.00%)  0 1/396 (0.25%)  1
Peripheral arterial occlusive disease † 1  2/398 (0.50%)  2 0/396 (0.00%)  0
Peripheral ischaemia † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
Vasculitis † 1  1/398 (0.25%)  1 0/396 (0.00%)  0
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 300 mg bd + Abiraterone 1000 mg qd Placebo bd + Abiraterone 1000 mg qd
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   374/398 (93.97%)      346/396 (87.37%)    
Blood and lymphatic system disorders     
Anaemia † 1  184/398 (46.23%)  293 67/396 (16.92%)  93
Lymphopenia † 1  24/398 (6.03%)  37 10/396 (2.53%)  11
Gastrointestinal disorders     
Abdominal pain † 1  27/398 (6.78%)  31 14/396 (3.54%)  14
Abdominal pain upper † 1  26/398 (6.53%)  30 16/396 (4.04%)  18
Constipation † 1  74/398 (18.59%)  84 59/396 (14.90%)  67
Diarrhoea † 1  80/398 (20.10%)  109 42/396 (10.61%)  52
Dyspepsia † 1  29/398 (7.29%)  38 17/396 (4.29%)  20
Nausea † 1  122/398 (30.65%)  173 56/396 (14.14%)  67
Vomiting † 1  60/398 (15.08%)  84 36/396 (9.09%)  42
General disorders     
Asthenia † 1  46/398 (11.56%)  53 40/396 (10.10%)  55
Fatigue † 1  112/398 (28.14%)  131 81/396 (20.45%)  91
Oedema peripheral † 1  49/398 (12.31%)  63 50/396 (12.63%)  62
Pyrexia † 1  27/398 (6.78%)  35 19/396 (4.80%)  24
Infections and infestations     
Upper respiratory tract infection † 1  21/398 (5.28%)  22 22/396 (5.56%)  25
Urinary tract infection † 1  42/398 (10.55%)  70 33/396 (8.33%)  41
Covid-19 † 1  36/398 (9.05%)  36 25/396 (6.31%)  26
Injury, poisoning and procedural complications     
Contusion † 1  31/398 (7.79%)  36 19/396 (4.80%)  19
Fall † 1  29/398 (7.29%)  35 28/396 (7.07%)  35
Investigations     
Alanine aminotransferase increased † 1  15/398 (3.77%)  19 27/396 (6.82%)  30
Aspartate aminotransferase increased † 1  16/398 (4.02%)  18 22/396 (5.56%)  26
Blood alkaline phosphatase increased † 1  22/398 (5.53%)  25 21/396 (5.30%)  24
Blood creatinine increased † 1  27/398 (6.78%)  52 19/396 (4.80%)  26
Lymphocyte count decreased † 1  34/398 (8.54%)  69 17/396 (4.29%)  26
Weight decreased † 1  27/398 (6.78%)  30 15/396 (3.79%)  16
White blood cell count decreased † 1  23/398 (5.78%)  48 10/396 (2.53%)  13
Metabolism and nutrition disorders     
Decreased appetite † 1  66/398 (16.58%)  81 31/396 (7.83%)  33
Hyperglycaemia † 1  30/398 (7.54%)  45 27/396 (6.82%)  36
Hypertriglyceridaemia † 1  24/398 (6.03%)  27 18/396 (4.55%)  20
Hypokalaemia † 1  33/398 (8.29%)  54 18/396 (4.55%)  25
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  58/398 (14.57%)  84 77/396 (19.44%)  116
Back pain † 1  82/398 (20.60%)  111 78/396 (19.70%)  89
Muscle spasms † 1  34/398 (8.54%)  44 19/396 (4.80%)  23
Musculoskeletal chest pain † 1  33/398 (8.29%)  47 28/396 (7.07%)  31
Myalgia † 1  22/398 (5.53%)  28 23/396 (5.81%)  29
Pain in extremity † 1  38/398 (9.55%)  46 38/396 (9.60%)  42
Nervous system disorders     
Dizziness † 1  49/398 (12.31%)  53 27/396 (6.82%)  32
Dysgeusia † 1  24/398 (6.03%)  26 7/396 (1.77%)  7
Headache † 1  39/398 (9.80%)  44 26/396 (6.57%)  32
Psychiatric disorders     
Insomnia † 1  31/398 (7.79%)  35 28/396 (7.07%)  30
Renal and urinary disorders     
Dysuria † 1  22/398 (5.53%)  25 18/396 (4.55%)  19
Respiratory, thoracic and mediastinal disorders     
Cough † 1  47/398 (11.81%)  59 29/396 (7.32%)  40
Dyspnoea † 1  38/398 (9.55%)  46 27/396 (6.82%)  33
Vascular disorders     
Hot flush † 1  35/398 (8.79%)  37 51/396 (12.88%)  52
Hypertension † 1  61/398 (15.33%)  80 74/396 (18.69%)  97
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
[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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03732820    
Other Study ID Numbers: D081SC00001
2018-002011-10 ( EudraCT Number )
First Submitted: September 28, 2018
First Posted: November 7, 2018
Results First Submitted: July 29, 2022
Results First Posted: June 15, 2023
Last Update Posted: February 28, 2024