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Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1)

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ClinicalTrials.gov Identifier: NCT01844986
Recruitment Status : Active, not recruiting
First Posted : May 3, 2013
Results First Posted : July 9, 2019
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
GOG Foundation
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 Newly Diagnosed
Advanced Ovarian Cancer
FIGO Stage III-IV
BRCA Mutation
Complete Response
Partial Response
First Line Platinum Chemotherapy
Intervention Drug: Olaparib 300mg tablets
Enrollment 450
Recruitment Details Patient enrolment was from 26 August 2013 to 13 February 2015. Enrolment was at 197 centres in 15 countries. 391 patients were randomized in the Global study. A further 59 were randomized to a separate China cohort (450 randomised in total). The Global study was used for the hypotheses testing of the study.
Pre-assignment Details It was planned that approximately 344 women with BRCA mutated ovarian cancer patients who are in clinical complete or partial response following first line 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 260 131
Completed 183 91
Not Completed 77 40
Reason Not Completed
Severe non-compliance to protocol             1             0
Withdrawal by Subject             21             14
Death             55             26
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 260 131 391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 260 participants 131 participants 391 participants
53.6  (9.38) 53.4  (9.79) 53.5  (9.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 131 participants 391 participants
Female
260
 100.0%
131
 100.0%
391
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 131 participants 391 participants
American Indian or Alaska Native
0
   0.0%
1
   0.8%
1
   0.3%
Asian
39
  15.0%
20
  15.3%
59
  15.1%
Native Hawaiian or Other Pacific Islander
1
   0.4%
1
   0.8%
2
   0.5%
Black or African American
2
   0.8%
2
   1.5%
4
   1.0%
White
214
  82.3%
106
  80.9%
320
  81.8%
More than one race
1
   0.4%
0
   0.0%
1
   0.3%
Unknown or Not Reported
3
   1.2%
1
   0.8%
4
   1.0%
Response to previous platinum chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 131 participants 391 participants
Complete Response
213
  81.9%
107
  81.7%
320
  81.8%
Partial Response
47
  18.1%
24
  18.3%
71
  18.2%
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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
Time Frame Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. Analysis of data assessed up to a maximum of 54 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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
13.8
(11.1 to 18.2)
[1]
Insufficient PFS events to estimate median, lower 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum 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
2.Secondary Outcome
Title Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
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 overall survival (OS)
Time Frame Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks (analysis of data assessed up to a maximum of 54 months). Analysed at the PFS analysis and a further analysis of OS will be performed at approximately 60% maturity.
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 260 131
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, lower 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8903
Comments Determined using a log-rank test stratified by response to previous platinum chemotherapy
Method Regression, Cox
Comments Model includes a factor for response to previous platinum chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.60 to 1.53
Estimation Comments A hazard ratio < 1 favours olaparib
3.Secondary Outcome
Title Efficacy in Patients Following First Line 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 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 to earliest progression by RECIST or Cancer Antigen-125 (CA-125)
Time Frame CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. Analysis of data assessed up to a maximum of 54 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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
12.0
(10.8 to 16.6)
[1]
Insufficient events to estimate median, lower 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.23 to 0.40
Estimation Comments A hazard ratio < 1 favours olaparib
4.Secondary Outcome
Title Efficacy in Patients Following First Line 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 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 randomisation to second progression (PFS2)
Time Frame Following first progression disease then assessed per local practice every 12 weeks until second progression. Analysis of data assessed up to a maximum of 54 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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
41.9
(36.5 to 47.9)
[1]
Insufficient PFS2 events to estimate median, lower 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.35 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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Time Frame Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisting of all patients who are randomized with a baseline and post baseline TOI scores 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 260 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.30
(-0.717 to 1.318)
3.30
(1.839 to 4.758)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
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 -3.00
Confidence Interval (2-Sided) 95%
-4.779 to -1.216
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to first subsequent therapy or death (TFST)
Time Frame Assessed every 12 weeks following treatment discontinuation. Analysis of data assessed up to a maximum of 54 months. A further analysis of TFST will be performed at approximately 60% OS maturity.
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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
51.8 [1] 
(44.3 to NA)
15.1
(12.7 to 20.5)
[1]
Insufficient TFST events to estimate the 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum 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
7.Secondary Outcome
Title Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to second subsequent therapy or death (TSST)
Time Frame Assessed every 12 weeks following treatment discontinuation. Analysis of data assessed up to a maximum of 54 months. A further analysis of TSST will be performed at approximately 60% OS maturity.
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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
40.7
(32.9 to 47.7)
[1]
Insufficient TSST events to estimate median, lower 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.32 to 0.63
Estimation Comments A hazard ratio < 1 favours olaparib
8.Secondary Outcome
Title Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to study treatment discontinuation or death (TDT).
Time Frame Time elapsed from randomization to study treatment discontinuation or death. Analysis of data assessed up to a maximum of 54 months. A further analysis of TDT may be performed at approximately 60% OS maturity.
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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
24.6
(24.0 to 24.8)
13.8
(11.2 to 16.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 300mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum chemotherapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.51 to 0.79
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 potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)
Time Frame Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.
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 260 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
13.8
(11.1 to 18.2)
[1]
Insufficient PFS events to estimate median, lower 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
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
Method Regression, Cox
Comments Model includes a factor for response to previous platinum 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
Time Frame Adverse Events, including Serious Adverse Events, will be collected from time of signature of informed consent, throughout the treatment period and up to and including the 30-day follow-up period after the last dose of study medication. All ongoing and any new AEs/SAEs identified during the 30 calendar days follow up period after last dose of study medication must be followed to resolution.
Adverse Event Reporting Description One patient in the placebo arm was randomised and not treated.
 
Arm/Group Title Olaparib 300 Tablets Placebo Tablets
Hide Arm/Group Description Taken orally twice daily Taken orally twice daily
All-Cause Mortality
Olaparib 300 Tablets Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   55/260 (21.15%)      27/131 (20.61%)    
Hide Serious Adverse Events
Olaparib 300 Tablets Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/260 (20.77%)      16/130 (12.31%)    
Blood and lymphatic system disorders     
Anaemia † 1  17/260 (6.54%)  36 0/130 (0.00%)  0
Febrile neutropenia † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Leukopenia † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Lymphopenia † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Neutropenia † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Splenic cyst † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Cardiac disorders     
Myocardial infarction † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Gastrointestinal disorders     
Abdominal pain † 1  2/260 (0.77%)  2 1/130 (0.77%)  1
Diarrhoea † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Ileus † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Incarcerated umbilical hernia † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Intestinal obstruction † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Small intestinal obstruction † 1  2/260 (0.77%)  2 1/130 (0.77%)  1
Subileus † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Umbilical hernia † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Vomiting † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
General disorders     
Chills † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Incarcerated hernia † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Pyrexia † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Infections and infestations     
Appendicitis † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Cellulitis † 1  1/260 (0.38%)  1 1/130 (0.77%)  1
Cystitis † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Infected lymphocele † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Medical device site cellulitis † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Pneumonia † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Sepsis † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Upper respiratory tract infection † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Urinary tract infection † 1  3/260 (1.15%)  3 0/130 (0.00%)  0
Urosepsis † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Viral infection † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Wound infection † 1  0/260 (0.00%)  0 1/130 (0.77%)  2
Injury, poisoning and procedural complications     
Accidental exposure to product by child † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Drug administration error † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Stab wound † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Thoracic vertebral fracture † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Wound complication † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Haemoglobin decreased † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Platelet count decreased † 1  1/260 (0.38%)  1 1/130 (0.77%)  1
Metabolism and nutrition disorders     
Cell death † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Limb discomfort † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Rotator cuff syndrome † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer female † 1  1/260 (0.38%)  1 3/130 (2.31%)  3
Intraductal proliferative breast lesion † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Invasive ductal breast carcinoma † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Lip and/or oral cavity cancer † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Thyroid cancer † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Thyroid cancer recurrent † 1  0/260 (0.00%)  0 1/130 (0.77%)  1
Nervous system disorders     
Ataxia † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Headache † 1  1/260 (0.38%)  1 2/130 (1.54%)  2
Neuropathy peripheral † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Syncope † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Transient ischaemic attack † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Psychiatric disorders     
Depression † 1  1/260 (0.38%)  1 0/130 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis † 1  2/260 (0.77%)  2 0/130 (0.00%)  0
Pulmonary embolism † 1  2/260 (0.77%)  3 0/130 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 300 Tablets Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   252/260 (96.92%)      116/130 (89.23%)    
Blood and lymphatic system disorders     
Anaemia † 1  90/260 (34.62%)  156 12/130 (9.23%)  18
Leukopenia † 1  16/260 (6.15%)  33 5/130 (3.85%)  5
Neutropenia † 1  40/260 (15.38%)  84 9/130 (6.92%)  11
Thrombocytopenia † 1  21/260 (8.08%)  52 2/130 (1.54%)  4
Gastrointestinal disorders     
Abdominal distension † 1  18/260 (6.92%)  22 10/130 (7.69%)  10
Abdominal pain † 1  63/260 (24.23%)  86 25/130 (19.23%)  28
Abdominal pain upper † 1  46/260 (17.69%)  61 17/130 (13.08%)  22
Constipation † 1  72/260 (27.69%)  97 25/130 (19.23%)  30
Diarrhoea † 1  89/260 (34.23%)  205 32/130 (24.62%)  58
Dyspepsia † 1  43/260 (16.54%)  50 16/130 (12.31%)  18
Nausea † 1  201/260 (77.31%)  412 49/130 (37.69%)  75
Stomatitis † 1  23/260 (8.85%)  37 3/130 (2.31%)  5
Vomiting † 1  104/260 (40.00%)  242 19/130 (14.62%)  26
General disorders     
Asthenia † 1  63/260 (24.23%)  131 16/130 (12.31%)  20
Fatigue † 1  106/260 (40.77%)  138 39/130 (30.00%)  48
Influenza like illness † 1  19/260 (7.31%)  29 11/130 (8.46%)  11
Mucosal inflammation † 1  17/260 (6.54%)  27 1/130 (0.77%)  1
Oedema peripheral † 1  24/260 (9.23%)  32 9/130 (6.92%)  10
Pyrexia † 1  31/260 (11.92%)  40 12/130 (9.23%)  15
Infections and infestations     
Cystitis † 1  15/260 (5.77%)  19 5/130 (3.85%)  8
Influenza † 1  19/260 (7.31%)  24 3/130 (2.31%)  3
Nasopharyngitis † 1  27/260 (10.38%)  38 17/130 (13.08%)  37
Sinusitis † 1  11/260 (4.23%)  12 8/130 (6.15%)  8
Upper respiratory tract infection † 1  28/260 (10.77%)  36 12/130 (9.23%)  15
Urinary tract infection † 1  29/260 (11.15%)  52 8/130 (6.15%)  10
Investigations     
Alanine aminotransferase increased † 1  9/260 (3.46%)  13 8/130 (6.15%)  8
Blood creatinine increased † 1  21/260 (8.08%)  30 2/130 (1.54%)  4
Neutrophil count decreased † 1  20/260 (7.69%)  40 7/130 (5.38%)  14
Weight increased † 1  13/260 (5.00%)  15 12/130 (9.23%)  12
White blood cell count decreased † 1  16/260 (6.15%)  37 6/130 (4.62%)  9
Metabolism and nutrition disorders     
Decreased appetite † 1  51/260 (19.62%)  68 13/130 (10.00%)  19
Hypokalaemia † 1  15/260 (5.77%)  24 3/130 (2.31%)  6
Hypomagnesaemia † 1  13/260 (5.00%)  17 10/130 (7.69%)  15
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  66/260 (25.38%)  88 35/130 (26.92%)  47
Back pain † 1  40/260 (15.38%)  50 16/130 (12.31%)  22
Muscle spasms † 1  17/260 (6.54%)  22 1/130 (0.77%)  1
Musculoskeletal pain † 1  16/260 (6.15%)  17 11/130 (8.46%)  13
Myalgia † 1  28/260 (10.77%)  36 13/130 (10.00%)  17
Pain in extremity † 1  28/260 (10.77%)  34 11/130 (8.46%)  15
Nervous system disorders     
Dizziness † 1  51/260 (19.62%)  68 20/130 (15.38%)  23
Dysgeusia † 1  68/260 (26.15%)  92 5/130 (3.85%)  6
Headache † 1  58/260 (22.31%)  109 30/130 (23.08%)  40
Neuropathy peripheral † 1  15/260 (5.77%)  15 7/130 (5.38%)  9
Psychiatric disorders     
Anxiety † 1  15/260 (5.77%)  15 11/130 (8.46%)  11
Depression † 1  12/260 (4.62%)  14 13/130 (10.00%)  15
Insomnia † 1  27/260 (10.38%)  31 16/130 (12.31%)  20
Respiratory, thoracic and mediastinal disorders     
Cough † 1  42/260 (16.15%)  57 28/130 (21.54%)  37
Dyspnoea † 1  39/260 (15.00%)  53 7/130 (5.38%)  7
Oropharyngeal pain † 1  21/260 (8.08%)  26 12/130 (9.23%)  15
Skin and subcutaneous tissue disorders     
Rash † 1  16/260 (6.15%)  23 11/130 (8.46%)  11
Vascular disorders     
Hot flush † 1  17/260 (6.54%)  25 11/130 (8.46%)  12
Hypertension † 1  9/260 (3.46%)  18 12/130 (9.23%)  17
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
The OS data were immature but there was no indication of an OS detriment, with the hazard ratio numerically favouring olaparib. Another analysis of OS will be performed at approximately 60% maturity. Analyses of TFST and TSST 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
Phone: +1 302 885 1180
EMail: ClinicalTrialTransparency@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01844986    
Other Study ID Numbers: D0818C00001
First Submitted: April 30, 2013
First Posted: May 3, 2013
Results First Submitted: May 9, 2019
Results First Posted: July 9, 2019
Last Update Posted: February 17, 2021