Trial Outcomes & Findings for Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats (NCT NCT01078662)
NCT ID: NCT01078662
Last Updated: 2025-08-13
Results Overview
Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Results posted on
2025-08-13
Participant Flow
This study was conducted at 13 sites across Israel, Germany, Spain, Australia, USA, Sweden. Enrolment started in Feb 2010 and was completed in Jul 2012. In total, 298 patients had received treatment (olaparib).
Patients \>17 years age with histologically and/or cytologically confirmed malignant solid tumours, refractory to standard therapy for which no suitable effective/curative therapy. Patients with confirmed deleterious or suspected deleterious BRCA mutation, Eastern Co-operative Oncology Group performance status ≤2 and life expectancy of ≥12 weeks. In total, 298 patients had received treatment.
Participant milestones
| Measure |
Breast Cancer
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
Patients with other primary cancers. Receiving olaparib 400mg BID
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
193
|
23
|
8
|
12
|
|
Overall Study
COMPLETED
|
4
|
25
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
58
|
168
|
21
|
7
|
11
|
Reasons for withdrawal
| Measure |
Breast Cancer
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
Patients with other primary cancers. Receiving olaparib 400mg BID
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
41
|
103
|
18
|
5
|
8
|
|
Overall Study
Patients reached data cut-off
|
12
|
53
|
2
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
11
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Baseline characteristics by cohort
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
n=12 Participants
Patients with other primary cancers. Receiving olaparib 400mg BID
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 7.99 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 9.86 • n=4 Participants
|
54.9 years
STANDARD_DEVIATION 12.38 • n=21 Participants
|
55.3 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
|
Age, Customized
< 50 years
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
|
Age, Customized
>=50 to <65 years
|
28 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
167 Participants
n=10 Participants
|
|
Age, Customized
>= 65 years
|
1 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
272 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
283 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 monthsPopulation: Full analysis set - all treated patients
Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Outcome measures
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
n=12 Participants
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
n=298 Participants
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Tumour Response Rate
|
12.9 Percentage of participants
Interval 5.74 to 23.85
|
31.1 Percentage of participants
Interval 24.64 to 38.13
|
21.7 Percentage of participants
Interval 7.46 to 43.7
|
50 Percentage of participants
Interval 15.7 to 84.3
|
8.3 Percentage of participants
Interval 0.21 to 38.48
|
26.2 Percentage of participants
Interval 21.27 to 31.55
|
SECONDARY outcome
Timeframe: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 monthsPopulation: Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline
Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Outcome measures
| Measure |
Breast Cancer
n=58 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=167 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=7 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
n=11 Participants
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
n=266 Participants
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Objective Response Rate
|
13.8 Percentage of participants
Interval 6.15 to 25.38
|
35.9 Percentage of participants
Interval 28.66 to 43.7
|
21.7 Percentage of participants
Interval 7.46 to 43.7
|
57.1 Percentage of participants
Interval 18.41 to 90.1
|
9.1 Percentage of participants
Interval 0.23 to 41.28
|
29.3 Percentage of participants
Interval 23.92 to 35.19
|
SECONDARY outcome
Timeframe: Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 monthsPopulation: Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
Outcome measures
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Progression Free Survival
|
3.68 months
Interval 1.76 to 7.52
|
7.03 months
Interval 3.65 to 11.24
|
4.55 months
Interval 1.81 to 8.21
|
7.15 months
Interval 2.63 to 17.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 monthsPopulation: Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.
Outcome measures
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
11.01 months
Interval 5.68 to 24.18
|
16.62 months
Interval 9.43 to
No enough data to calculate upper limit
|
9.81 months
Interval 3.84 to 16.62
|
18.38 months
Interval 6.24 to 25.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 monthsPopulation: Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose
Outcome measures
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Overall Survival Rate at 12 Months
|
44.7 Percentage of participants
Interval 5.68 to 24.18
|
64.4 Percentage of participants
Interval 9.43 to
|
40.9 Percentage of participants
Interval 3.84 to 16.62
|
50 Percentage of participants
Interval 6.24 to 25.46
|
—
|
—
|
SECONDARY outcome
Timeframe: From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 monthsPopulation: Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.
Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.
Outcome measures
| Measure |
Breast Cancer
n=8 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=60 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=5 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=4 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
n=1 Participants
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
n=78 Participants
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Duration of Response
|
204 days
Interval 149.5 to 405.0
|
225 days
Interval 143.0 to 410.0
|
134 days
Interval 131.0 to 141.0
|
326.5 days
Interval 164.0 to 476.0
|
165 days
Interval 165.0 to 165.0
|
208 days
Interval 134.0 to 410.0
|
SECONDARY outcome
Timeframe: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16Population: Full analysis set - all treated patients
Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.
Outcome measures
| Measure |
Breast Cancer
n=62 Participants
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
|
Ovarian Cancer
n=193 Participants
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
|
Pancreatic Cancer
n=23 Participants
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
|
Prostate Cancer
n=8 Participants
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
Other Cancers
n=12 Participants
Patients with other primary cancers. Receiving olaparib 400mg BID
|
All Patients
n=298 Participants
Patients of different cancer types
|
|---|---|---|---|---|---|---|
|
Disease Control Rate at Week 16
|
37.1 Percentage of participants
Interval 25.16 to 50.31
|
58 Percentage of participants
Interval 50.73 to 65.08
|
47.8 Percentage of participants
Interval 26.82 to 69.41
|
62.5 Percentage of participants
Interval 24.49 to 91.48
|
33.3 Percentage of participants
Interval 9.92 to 65.11
|
52 Percentage of participants
Interval 46.18 to 57.81
|
Adverse Events
OLAPARIB
Serious events: 90 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OLAPARIB
n=298 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.4%
13/298 • Number of events 14
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.0%
3/298 • Number of events 3
|
|
Gastrointestinal disorders
ENTERITIS
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL MASS
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
2.3%
7/298 • Number of events 8
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.67%
2/298 • Number of events 2
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.67%
2/298 • Number of events 2
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.34%
1/298 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.34%
1/298 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.34%
1/298 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.34%
1/298 • Number of events 1
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.67%
2/298 • Number of events 2
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.34%
1/298 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.0%
3/298 • Number of events 3
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.67%
2/298 • Number of events 3
|
|
Ear and labyrinth disorders
VERTIGO
|
0.34%
1/298 • Number of events 1
|
|
Eye disorders
DIPLOPIA
|
0.34%
1/298 • Number of events 1
|
|
Eye disorders
RETINAL DETACHMENT
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.7%
11/298 • Number of events 12
|
|
Gastrointestinal disorders
ASCITES
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.0%
3/298 • Number of events 4
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.67%
2/298 • Number of events 2
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
ILEUS
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.34%
1/298 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.3%
7/298 • Number of events 9
|
|
Gastrointestinal disorders
VOMITING
|
1.7%
5/298 • Number of events 6
|
|
General disorders
DEVICE OCCLUSION
|
0.34%
1/298 • Number of events 1
|
|
General disorders
FATIGUE
|
0.34%
1/298 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.34%
1/298 • Number of events 1
|
|
General disorders
PYREXIA
|
1.0%
3/298 • Number of events 3
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
BACTERAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
ENTEROBACTER SEPSIS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
INFECTION
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
1.3%
4/298 • Number of events 4
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.34%
1/298 • Number of events 2
|
|
Infections and infestations
SEPSIS
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.34%
1/298 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.34%
1/298 • Number of events 1
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.34%
1/298 • Number of events 1
|
|
Injury, poisoning and procedural complications
PROCEDURAL HAEMORRHAGE
|
0.34%
1/298 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.67%
2/298 • Number of events 2
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.34%
1/298 • Number of events 1
|
|
Investigations
PLATELET COUNT DECREASED
|
0.34%
1/298 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.34%
1/298 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.34%
1/298 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
HAEMARTHROSIS
|
0.34%
1/298 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.67%
2/298 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.34%
1/298 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LEUKAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.34%
1/298 • Number of events 1
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.34%
1/298 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.67%
2/298 • Number of events 3
|
|
Nervous system disorders
SYNCOPE
|
0.67%
2/298 • Number of events 2
|
|
Psychiatric disorders
ANXIETY
|
0.34%
1/298 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.34%
1/298 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.34%
1/298 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.34%
1/298 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.34%
1/298 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.3%
4/298 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.3%
4/298 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.3%
4/298 • Number of events 4
|
Other adverse events
| Measure |
OLAPARIB
n=298 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
30.2%
90/298 • Number of events 120
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
9.4%
28/298 • Number of events 36
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.4%
19/298 • Number of events 20
|
|
Gastrointestinal disorders
DYSPEPSIA
|
17.4%
52/298 • Number of events 54
|
|
General disorders
ASTHENIA
|
8.4%
25/298 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.7%
17/298 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.4%
16/298 • Number of events 18
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
7.7%
23/298 • Number of events 35
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
11.1%
33/298 • Number of events 35
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
22.1%
66/298 • Number of events 85
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.4%
25/298 • Number of events 27
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.1%
42/298 • Number of events 53
|
|
Gastrointestinal disorders
DIARRHOEA
|
27.2%
81/298 • Number of events 103
|
|
Gastrointestinal disorders
FLATULENCE
|
7.7%
23/298 • Number of events 28
|
|
Gastrointestinal disorders
NAUSEA
|
59.1%
176/298 • Number of events 218
|
|
Gastrointestinal disorders
VOMITING
|
36.6%
109/298 • Number of events 158
|
|
General disorders
FATIGUE
|
59.1%
176/298 • Number of events 199
|
|
General disorders
OEDEMA PERIPHERAL
|
13.8%
41/298 • Number of events 48
|
|
General disorders
PYREXIA
|
12.4%
37/298 • Number of events 51
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.7%
23/298 • Number of events 26
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.7%
23/298 • Number of events 29
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.1%
30/298 • Number of events 44
|
|
Investigations
BLOOD CREATININE INCREASED
|
7.0%
21/298 • Number of events 21
|
|
Investigations
WEIGHT DECREASED
|
8.7%
26/298 • Number of events 26
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.8%
62/298 • Number of events 67
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.1%
27/298 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.4%
37/298 • Number of events 43
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.1%
27/298 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.0%
15/298 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.4%
25/298 • Number of events 26
|
|
Nervous system disorders
DIZZINESS
|
11.4%
34/298 • Number of events 34
|
|
Nervous system disorders
DYSGEUSIA
|
15.8%
47/298 • Number of events 47
|
|
Nervous system disorders
HEADACHE
|
16.1%
48/298 • Number of events 60
|
|
Psychiatric disorders
ANXIETY
|
5.7%
17/298 • Number of events 17
|
|
Psychiatric disorders
DEPRESSION
|
6.4%
19/298 • Number of events 19
|
|
Psychiatric disorders
INSOMNIA
|
7.4%
22/298 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.1%
42/298 • Number of events 52
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.1%
36/298 • Number of events 44
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.0%
15/298 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.0%
15/298 • Number of events 16
|
|
Vascular disorders
HOT FLUSH
|
6.4%
19/298 • Number of events 20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60