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Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

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: NCT02184195
Recruitment Status : Active, not recruiting
First Posted : July 9, 2014
Results First Posted : January 27, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme Corp.
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
Conditions Germline BRCA1/2 Mutations and
Metastatic Adenocarcinoma of the Pancreas
Interventions Drug: Olaparib
Drug: Placebo
Enrollment 154
Recruitment Details This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1).
Pre-assignment Details Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Period Title: Overall Study
Started 92 62
Completed 49 27
Not Completed 43 35
Reason Not Completed
Patient decision             3             1
Eligibility criteria not fulfilled             0             1
Death             40             29
Lost to Follow-up             0             2
Other             0             2
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo Total
Hide Arm/Group Description Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. Total of all reporting groups
Overall Number of Baseline Participants 92 62 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 62 participants 154 participants
58.2  (10.27) 56.4  (9.07) 57.5  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 62 participants 154 participants
Female
39
  42.4%
31
  50.0%
70
  45.5%
Male
53
  57.6%
31
  50.0%
84
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 62 participants 154 participants
Hispanic or Latino
4
   4.3%
2
   3.2%
6
   3.9%
Not Hispanic or Latino
88
  95.7%
60
  96.8%
148
  96.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 62 participants 154 participants
American Indian or Alaska Native
1
   1.1%
0
   0.0%
1
   0.6%
Asian
4
   4.3%
2
   3.2%
6
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   5.4%
0
   0.0%
5
   3.2%
White
82
  89.1%
59
  95.2%
141
  91.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.6%
1
   0.6%
1.Primary Outcome
Title Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
7.4
(4.14 to 11.01)
3.8
(3.52 to 4.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.531
Confidence Interval (2-Sided) 95%
0.346 to 0.815
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
Time Frame Upto 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
18.9
(14.85 to 26.15)
18.1
(12.62 to 26.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6833
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.906
Confidence Interval (2-Sided) 95%
0.563 to 1.457
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time From Randomisation to Second Progression (PFS2)
Hide Description To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
13.2
(7.75 to 26.15)
9.2
(7.62 to 13.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2597
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.464 to 1.230
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time From Randomisation to Second Subsequent Therapy or Death (TSST)
Hide Description To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
13.2
(8.84 to 20.04)
9.2
(8.34 to 13.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0825
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.678
Confidence Interval (2-Sided) 95%
0.437 to 1.051
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time From Randomisation to First Subsequent Therapy or Death (TFST)
Hide Description To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
8.6
(6.21 to 12.45)
5.7
(4.17 to 6.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.496
Confidence Interval (2-Sided) 95%
0.324 to 0.760
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
Hide Description To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Median (95% Confidence Interval)
Unit of Measure: Months
7.2
(5.52 to 10.84)
3.8
(3.55 to 4.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.446
Confidence Interval (2-Sided) 95%
0.297 to 0.670
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
Hide Description To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients with measurable disease at baseline.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 78 52
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with response
18
  23.1%
6
  11.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1028
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.300
Confidence Interval (2-Sided) 95%
0.886 to 6.761
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
Hide Description Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.
Time Frame At 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): All randomised patients
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 92 62
Measure Type: Number
Unit of Measure: Participants
Yes 49 23
No 41 35
Not evaluable/missing 2 4
9.Secondary Outcome
Title Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
Hide Description

To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.

A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.

bd twice daily.

Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 89 58
Mean (95% Confidence Interval)
Unit of Measure: Unit on scale
-1.20
(-4.014 to 1.618)
1.27
(-2.580 to 5.124)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300 mg Twice Daily (bd), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.47
Confidence Interval (2-Sided) 95%
-7.267 to 2.327
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description:
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Number of Participants Analyzed 91 60
Measure Type: Number
Unit of Measure: Participants
Any AE 87 56
Any AE of CTCAE Grade 3 or higher 36 14
Any AE with outcome = death 0 0
Any SAE (including events with outcome = death) 22 9
AnyAE leading to withdrawal of olaparib/placebo 5 1
Any AE leading to dose interruption 32 3
Any AE leading to dose reduction 15 2
Time Frame From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olaparib 300 mg Twice Daily (bd) Placebo
Hide Arm/Group Description Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
All-Cause Mortality
Olaparib 300 mg Twice Daily (bd) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   41/92 (44.57%)   30/62 (48.39%) 
Hide Serious Adverse Events
Olaparib 300 mg Twice Daily (bd) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/91 (24.18%)   9/60 (15.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  6/91 (6.59%)  0/60 (0.00%) 
Febrile Neutropenia * 1  0/91 (0.00%)  1/60 (1.67%) 
Cardiac disorders     
Cardiac failure * 1  1/91 (1.10%)  1/60 (1.67%) 
Endocrine disorders     
Hypothyroidism * 1  1/91 (1.10%)  0/60 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  3/91 (3.30%)  1/60 (1.67%) 
Constipation * 1  1/91 (1.10%)  0/60 (0.00%) 
Duodenal perforation * 1  1/91 (1.10%)  0/60 (0.00%) 
Gastric varices haemorrhage * 1  1/91 (1.10%)  0/60 (0.00%) 
Incarcerated inguinal hernia * 1  1/91 (1.10%)  0/60 (0.00%) 
Large intestinal obstruction * 1  1/91 (1.10%)  0/60 (0.00%) 
Melaena * 1  1/91 (1.10%)  0/60 (0.00%) 
Obstruction gastric * 1  1/91 (1.10%)  0/60 (0.00%) 
Pancreatitis * 1  1/91 (1.10%)  0/60 (0.00%) 
Vomiting * 1  1/91 (1.10%)  3/60 (5.00%) 
General disorders     
General physical health deterioration * 1  1/91 (1.10%)  0/60 (0.00%) 
Pyrexia * 1  0/91 (0.00%)  2/60 (3.33%) 
Hepatobiliary disorders     
Bile duct obstruction * 1  1/91 (1.10%)  0/60 (0.00%) 
Cholangitis * 1  2/91 (2.20%)  1/60 (1.67%) 
Cholecystitis * 1  1/91 (1.10%)  0/60 (0.00%) 
Infections and infestations     
Abdominal infection * 1  1/91 (1.10%)  0/60 (0.00%) 
Bartholinitis * 1  1/91 (1.10%)  0/60 (0.00%) 
Pneumonia * 1  1/91 (1.10%)  0/60 (0.00%) 
Urinary tract infection * 1  1/91 (1.10%)  0/60 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic haemorrhage * 1  1/91 (1.10%)  0/60 (0.00%) 
Investigations     
Platelet count decreased * 1  1/91 (1.10%)  0/60 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/91 (1.10%)  0/60 (0.00%) 
Hyperglycaemia * 1  0/91 (0.00%)  1/60 (1.67%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/91 (1.10%)  0/60 (0.00%) 
Embolic stroke * 1  0/91 (0.00%)  1/60 (1.67%) 
Transient ischaemic attack * 1  1/91 (1.10%)  0/60 (0.00%) 
Product Issues     
Device occlusion * 1  1/91 (1.10%)  0/60 (0.00%) 
Stent malfunction * 1  1/91 (1.10%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/91 (1.10%)  0/60 (0.00%) 
Pneumothorax * 1  1/91 (1.10%)  0/60 (0.00%) 
Vascular disorders     
Vascular stenosis * 1  1/91 (1.10%)  0/60 (0.00%) 
1
Term from vocabulary, MedDRA version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 300 mg Twice Daily (bd) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   87/91 (95.60%)   56/60 (93.33%) 
Blood and lymphatic system disorders     
Anaemia * 1  23/91 (25.27%)  10/60 (16.67%) 
Neutropenia * 1  7/91 (7.69%)  4/60 (6.67%) 
Thrombocytopenia * 1  7/91 (7.69%)  4/60 (6.67%) 
Gastrointestinal disorders     
Nausea * 1  41/91 (45.05%)  14/60 (23.33%) 
Diarrhoea * 1  26/91 (28.57%)  9/60 (15.00%) 
Abdominal pain * 1  23/91 (25.27%)  14/60 (23.33%) 
Constipation * 1  20/91 (21.98%)  6/60 (10.00%) 
Vomiting * 1  18/91 (19.78%)  8/60 (13.33%) 
Stomatitis * 1  7/91 (7.69%)  3/60 (5.00%) 
Abdominal pain upper * 1  6/91 (6.59%)  8/60 (13.33%) 
Dry mouth * 1  6/91 (6.59%)  1/60 (1.67%) 
Dyspepsia * 1  5/91 (5.49%)  5/60 (8.33%) 
Abdominal distension * 1  4/91 (4.40%)  6/60 (10.00%) 
Flatulence * 1  2/91 (2.20%)  4/60 (6.67%) 
General disorders     
Fatigue * 1  41/91 (45.05%)  16/60 (26.67%) 
Asthenia * 1  15/91 (16.48%)  5/60 (8.33%) 
Pyrexia * 1  12/91 (13.19%)  3/60 (5.00%) 
Oedema peripheral * 1  8/91 (8.79%)  5/60 (8.33%) 
Infections and infestations     
Nasopharyngitis * 1  11/91 (12.09%)  2/60 (3.33%) 
Influenza * 1  5/91 (5.49%)  0/60 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  8/91 (8.79%)  1/60 (1.67%) 
Aspartate aminotransferase increased * 1  6/91 (6.59%)  1/60 (1.67%) 
Blood creatinine increased * 1  6/91 (6.59%)  1/60 (1.67%) 
Blood alkaline phosphatase increased * 1  5/91 (5.49%)  3/60 (5.00%) 
Platelet count decreased * 1  5/91 (5.49%)  0/60 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  22/91 (24.18%)  4/60 (6.67%) 
Hyperglycaemia * 1  8/91 (8.79%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  17/91 (18.68%)  10/60 (16.67%) 
Arthralgia * 1  14/91 (15.38%)  6/60 (10.00%) 
Muscle spasms * 1  6/91 (6.59%)  2/60 (3.33%) 
Pain in extremity * 1  6/91 (6.59%)  4/60 (6.67%) 
Musculoskeletal pain * 1  5/91 (5.49%)  3/60 (5.00%) 
Myalgia * 1  5/91 (5.49%)  3/60 (5.00%) 
Flank pain * 1  1/91 (1.10%)  4/60 (6.67%) 
Nervous system disorders     
Dysgeusia * 1  10/91 (10.99%)  3/60 (5.00%) 
Neuropathy peripheral * 1  7/91 (7.69%)  7/60 (11.67%) 
Dizziness * 1  6/91 (6.59%)  3/60 (5.00%) 
Headache * 1  6/91 (6.59%)  8/60 (13.33%) 
Peripheral sensory neuropathy * 1  6/91 (6.59%)  2/60 (3.33%) 
Psychiatric disorders     
Insomnia * 1  7/91 (7.69%)  1/60 (1.67%) 
Anxiety * 1  5/91 (5.49%)  2/60 (3.33%) 
Depression * 1  5/91 (5.49%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  10/91 (10.99%)  3/60 (5.00%) 
Cough * 1  8/91 (8.79%)  2/60 (3.33%) 
Skin and subcutaneous tissue disorders     
Rash * 1  11/91 (12.09%)  2/60 (3.33%) 
Pruritus * 1  9/91 (9.89%)  4/60 (6.67%) 
1
Term from vocabulary, MedDRA version 21.1
*
Indicates events were collected by non-systematic assessment
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.
This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Leader
Organization: AstraZeneca AB
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02184195    
Other Study ID Numbers: D081FC00001
2014-001589-85 ( EudraCT Number )
First Submitted: June 6, 2014
First Posted: July 9, 2014
Results First Submitted: January 14, 2020
Results First Posted: January 27, 2020
Last Update Posted: November 3, 2020