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Trial record 1 of 1 for:    NCT01874353
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Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

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ClinicalTrials.gov Identifier: NCT01874353
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Results First Posted : February 7, 2018
Last Update Posted : July 31, 2020
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
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 Platinum Sensitive
BRCA Mutated
Relapsed Ovarian Cancer
Following Complete or Partial Response to Platinum Based Chemotherapy
Interventions Drug: Olaparib 300mg tablets
Drug: Placebo to match olaparib 300mg
Enrollment 337
Recruitment Details The first patient was screened on 03 September 2013 and the last patient was screened on 21 November 2014. Patients were screened at 119 centres in 16 countries. Of the 602 patients screened, 295 were randomized.
Pre-assignment Details It was planned that approximately 264 women with BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description Taken orally twice daily Taken orally twice daily
Period Title: Overall Study
Started 196 99
Completed 141 62
Not Completed 55 37
Reason Not Completed
Other             2             0
Lost to Follow-up             1             1
Death             45             27
Withdrawal by Subject             7             9
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets Total
Hide Arm/Group Description Taken orally twice daily Taken orally twice daily Total of all reporting groups
Overall Number of Baseline Participants 196 99 295
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 196 participants 99 participants 295 participants
57.0  (9.20) 56.6  (8.90) 56.9  (9.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants 99 participants 295 participants
Female
196
 100.0%
99
 100.0%
295
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Response to previous platinum chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 99 participants 295 participants
Complete Response 91 47 138
Partial Response 105 52 157
Time to disease progression in the penultimate platinum chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 99 participants 295 participants
>6 - 12 months 79 40 119
>12 months 117 59 176
1.Primary Outcome
Title Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
Hide Description To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Time Frame Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
19.1
(16.3 to 25.7)
5.5
(5.2 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.22 to 0.41
Estimation Comments A hazard ratio < 1 favours olaparib
2.Secondary Outcome
Title Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).
Time Frame Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks (assessed up to a maximum of 36 months). Analyzed at the time of the primary analysis of PFS and a further analysis of OS will be performed at approximately 60% maturity.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Insufficient OS events to estimate median and 95% confidence interval
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4267
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.50 to 1.31
Estimation Comments A hazard ratio <1 favours olaparib
3.Secondary Outcome
Title Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.
Time Frame CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks until objective radiological disease progression. Assessed up to a maximum of 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
16.9
(14.6 to 22.3)
4.9
(3.7 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.23 to 0.41
Estimation Comments A hazard ratio < 1 favours olaparib
4.Secondary Outcome
Title Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression
Time Frame Radiologic scans performed at baseline then every 12 weeks for 72 weeks, then every 24 weeks thereafter until first progression. Disease then assessed per local practice every 12 weeks until second progression. Assessed up to a maximum of 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(24.1 to NA)
18.4
(15.4 to 22.8)
[1]
Insufficient PFS2 events to estimate median and upper confidence limit.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.34 to 0.72
Estimation Comments A hazard ratio < 1 favours olaparib
5.Secondary Outcome
Title Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Hide Description To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Time Frame Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized with a baseline and post baseline TOI score available
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 185 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Change in TOI over 12 months
-2.90
(-4.131 to -1.673)
-2.87
(-4.643 to -1.097)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9765
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-2.191 to 2.126
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST).
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).
Time Frame Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TFST will be performed at approximately 60% OS maturity.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomised
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
27.9 [1] 
(22.6 to NA)
7.1
(6.3 to 8.3)
[1]
Insufficient TFST events to estimate upper confidence limit.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.21 to 0.38
Estimation Comments A hazard ratio < 1 favours olaparib
7.Secondary Outcome
Title Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST).
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST).
Time Frame Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TSST will be performed at approximately 60% OS maturity.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
18.2
(15.0 to 20.5)
[1]
Insufficient TSST events for median and 95% confidence interval to be estimated
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.26 to 0.53
Estimation Comments A hazard ratio < 1 favours olaparib
8.Secondary Outcome
Title Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT).
Hide Description To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT).
Time Frame Time elapsed from randomization to study treatment discontinuation or death. Assessed up to a maximum of 36 months. A further analysis of TDT will be performed at approximately 60% OS maturity.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 196 99
Median (95% Confidence Interval)
Unit of Measure: Months
19.4
(14.9 to 26.9)
5.6
(5.0 to 7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.23 to 0.42
Estimation Comments A hazard ratio < 1 favours olaparib
9.Secondary Outcome
Title Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.
Hide Description To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
Time Frame Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized and confirmed as Myriad gBRCAm
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily
Taken orally twice daily
Overall Number of Participants Analyzed 190 96
Median (95% Confidence Interval)
Unit of Measure: Months
19.3
(16.5 to 27.3)
5.5
(5.0 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
Method Regression, Cox
Comments Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.22 to 0.40
Estimation Comments A hazard ratio < 1 favours olaparib
10.Secondary Outcome
Title To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
Hide Description To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy
Time Frame Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data
Arm/Group Title Olaparib 300mg Tablets
Hide Arm/Group Description:
Taken orally twice daily
Overall Number of Participants Analyzed 93
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
Day 1 - Pre-dose
NA [1] 
(NA%)
Day 1 - 1 hour
3.26
(312.2%)
Day 15 - Pre-dose
0.92
(95.5%)
Day 15 - 1 hour
5.12
(61.8%)
Day 29 - Pre-dose
0.94
(179.0%)
[1]
Prior to receiving olaparib so not calculated
Time Frame [Not Specified]
Adverse Event Reporting Description One patient in the olaparib arm was randomised in error and did not receive study treatment.
 
Arm/Group Title Olaparib 300mg Tablets Placebo Tablets
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Olaparib 300mg Tablets Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Olaparib 300mg Tablets Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/195 (17.95%)      8/99 (8.08%)    
Blood and lymphatic system disorders     
Anaemia  1  7/195 (3.59%)  12 0/99 (0.00%)  0
Febrile neutropenia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Neutropenia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  9/195 (4.62%)  14 0/99 (0.00%)  0
Cardiac disorders     
Pericarditis  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Gastrointestinal disorders     
Abdominal hernia  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Abdominal pain  1  3/195 (1.54%)  3 0/99 (0.00%)  0
Ascites  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Constipation  1  0/195 (0.00%)  0 2/99 (2.02%)  2
Dysphagia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Intestinal obstruction  1  3/195 (1.54%)  4 1/99 (1.01%)  1
Nausea  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Small intestinal obstruction  1  0/195 (0.00%)  0 2/99 (2.02%)  3
Vomiting  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  8/195 (4.10%)  11 5/99 (5.05%)  7
General disorders     
Fatigue  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Malaise  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Oedema peripheral  1  1/195 (0.51%)  2 0/99 (0.00%)  0
Pyrexia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  4/195 (2.05%)  5 0/99 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Hypersensitivity  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  2/195 (1.03%)  2 0/99 (0.00%)  0
Infections and infestations     
Neutropenic sepsis  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Pneumonia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Urinary tract infection  1  1/195 (0.51%)  1 1/99 (1.01%)  1
Total  1  3/195 (1.54%)  3 1/99 (1.01%)  1
Injury, poisoning and procedural complications     
Incisional hernia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Post procedural fistula  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Total  1  1/195 (0.51%)  1 1/99 (1.01%)  1
Investigations     
Amylase increased  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Blood creatine phosphokinase increased  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Blood creatinine increased  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  2/195 (1.03%)  2 1/99 (1.01%)  1
Metabolism and nutrition disorders     
Hypokalaemia  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Total  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Muscular weakness  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  1/195 (0.51%)  1 1/99 (1.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Gastric cancer  1  2/195 (1.03%)  2 0/99 (0.00%)  0
Hepatic neoplasm  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Invasive ductal breast carcinoma  1  0/195 (0.00%)  0 1/99 (1.01%)  1
Myelodysplastic syndrome  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  5/195 (2.56%)  5 1/99 (1.01%)  1
Renal and urinary disorders     
Haematuria  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Dyspnoea  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Pneumonitis  1  1/195 (0.51%)  1 0/99 (0.00%)  0
Total  1  3/195 (1.54%)  3 0/99 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  2/195 (1.03%)  2 1/99 (1.01%)  1
Total  1  2/195 (1.03%)  2 1/99 (1.01%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 300mg Tablets Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   192/195 (98.46%)      94/99 (94.95%)    
Blood and lymphatic system disorders     
Anaemia  1  78/195 (40.00%)  130 7/99 (7.07%)  7
Leukopenia  1  20/195 (10.26%)  27 1/99 (1.01%)  1
Neutropenia  1  22/195 (11.28%)  38 5/99 (5.05%)  11
Thrombocytopenia  1  16/195 (8.21%)  19 3/99 (3.03%)  3
Total  1  92/195 (47.18%)  220 12/99 (12.12%)  22
Cardiac disorders     
Total  1  10/195 (5.13%)  11 4/99 (4.04%)  4
Ear and labyrinth disorders     
Total  1  18/195 (9.23%)  20 5/99 (5.05%)  5
Eye disorders     
Total  1  12/195 (6.15%)  17 4/99 (4.04%)  6
Gastrointestinal disorders     
Abdominal distension  1  11/195 (5.64%)  11 7/99 (7.07%)  7
Abdominal pain  1  45/195 (23.08%)  77 31/99 (31.31%)  33
Abdominal pain lower  1  10/195 (5.13%)  10 1/99 (1.01%)  1
Abdominal pain upper  1  21/195 (10.77%)  24 12/99 (12.12%)  13
Constipation  1  40/195 (20.51%)  53 23/99 (23.23%)  29
Diarrhoea  1  64/195 (32.82%)  113 20/99 (20.20%)  28
Dry mouth  1  11/195 (5.64%)  18 4/99 (4.04%)  4
Dyspepsia  1  22/195 (11.28%)  33 8/99 (8.08%)  8
Flatulence  1  10/195 (5.13%)  11 1/99 (1.01%)  1
Gastrooesophageal reflux disease  1  13/195 (6.67%)  13 3/99 (3.03%)  3
Nausea  1  148/195 (75.90%)  265 33/99 (33.33%)  44
Stomatitis  1  20/195 (10.26%)  29 6/99 (6.06%)  7
Total  1  176/195 (90.26%)  891 75/99 (75.76%)  236
Vomiting  1  72/195 (36.92%)  131 19/99 (19.19%)  25
General disorders     
Asthenia  1  61/195 (31.28%)  99 27/99 (27.27%)  29
Fatigue  1  74/195 (37.95%)  89 15/99 (15.15%)  22
Influenza like illness  1  12/195 (6.15%)  12 1/99 (1.01%)  1
Mucosal inflammation  1  10/195 (5.13%)  13 3/99 (3.03%)  4
Oedema peripheral  1  15/195 (7.69%)  18 6/99 (6.06%)  7
Pyrexia  1  26/195 (13.33%)  32 6/99 (6.06%)  9
Total  1  152/195 (77.95%)  301 48/99 (48.48%)  77
Infections and infestations     
Cystitis  1  13/195 (6.67%)  23 0/99 (0.00%)  0
Influenza  1  13/195 (6.67%)  13 6/99 (6.06%)  6
Nasopharyngitis  1  21/195 (10.77%)  35 11/99 (11.11%)  12
Oral herpes  1  11/195 (5.64%)  14 3/99 (3.03%)  4
Total  1  106/195 (54.36%)  235 39/99 (39.39%)  78
Upper respiratory tract infection  1  14/195 (7.18%)  16 5/99 (5.05%)  9
Urinary tract infection  1  17/195 (8.72%)  22 9/99 (9.09%)  11
Injury, poisoning and procedural complications     
Total  1  30/195 (15.38%)  43 10/99 (10.10%)  12
Investigations     
Alanine aminotransferase increased  1  10/195 (5.13%)  13 4/99 (4.04%)  4
Blood creatinine increased  1  20/195 (10.26%)  29 1/99 (1.01%)  1
Neutrophil count decreased  1  14/195 (7.18%)  29 1/99 (1.01%)  2
Platelet count decreased  1  12/195 (6.15%)  25 0/99 (0.00%)  0
Total  1  56/195 (28.72%)  178 14/99 (14.14%)  33
White blood cell count decreased  1  11/195 (5.64%)  32 1/99 (1.01%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  43/195 (22.05%)  53 11/99 (11.11%)  11
Hypomagnesaemia  1  28/195 (14.36%)  51 10/99 (10.10%)  10
Total  1  88/195 (45.13%)  171 26/99 (26.26%)  41
Musculoskeletal and connective tissue disorders     
Arthralgia  1  29/195 (14.87%)  31 15/99 (15.15%)  15
Back pain  1  23/195 (11.79%)  28 12/99 (12.12%)  14
Muscle spasms  1  19/195 (9.74%)  25 5/99 (5.05%)  5
Musculoskeletal pain  1  7/195 (3.59%)  9 6/99 (6.06%)  6
Myalgia  1  17/195 (8.72%)  19 5/99 (5.05%)  8
Pain in extremity  1  17/195 (8.72%)  23 7/99 (7.07%)  8
Total  1  89/195 (45.64%)  182 46/99 (46.46%)  78
Nervous system disorders     
Dizziness  1  26/195 (13.33%)  33 5/99 (5.05%)  6
Dysgeusia  1  52/195 (26.67%)  60 7/99 (7.07%)  7
Headache  1  49/195 (25.13%)  79 13/99 (13.13%)  14
Neuropathy peripheral  1  12/195 (6.15%)  12 4/99 (4.04%)  5
Paraesthesia  1  10/195 (5.13%)  11 5/99 (5.05%)  5
Total  1  111/195 (56.92%)  238 32/99 (32.32%)  49
Psychiatric disorders     
Anxiety  1  12/195 (6.15%)  13 5/99 (5.05%)  5
Insomnia  1  11/195 (5.64%)  14 9/99 (9.09%)  9
Total  1  37/195 (18.97%)  49 14/99 (14.14%)  18
Renal and urinary disorders     
Total  1  18/195 (9.23%)  31 11/99 (11.11%)  12
Reproductive system and breast disorders     
Total  1  16/195 (8.21%)  22 5/99 (5.05%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  32/195 (16.41%)  42 5/99 (5.05%)  5
Dyspnoea  1  22/195 (11.28%)  29 1/99 (1.01%)  1
Oropharyngeal pain  1  14/195 (7.18%)  17 5/99 (5.05%)  5
Total  1  72/195 (36.92%)  131 14/99 (14.14%)  17
Skin and subcutaneous tissue disorders     
Total  1  58/195 (29.74%)  99 26/99 (26.26%)  32
Alopecia  1  11/195 (5.64%)  11 6/99 (6.06%)  6
Pruritus  1  13/195 (6.67%)  15 4/99 (4.04%)  4
Rash  1  12/195 (6.15%)  16 5/99 (5.05%)  5
Vascular disorders     
Total  1  20/195 (10.26%)  23 7/99 (7.07%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
The OS data were immature but there was no indication of an OS detriment, with the HR numerically favouring olaparib. Another analysis of OS will be performed at approximately 60% maturity. Analyses of TFST, TSST and TDT will also be performed.
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: Elizabeth Lowe
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01874353    
Other Study ID Numbers: D0816C00002
First Submitted: June 7, 2013
First Posted: June 11, 2013
Results First Submitted: September 15, 2017
Results First Posted: February 7, 2018
Last Update Posted: July 31, 2020