Trial Outcomes & Findings for Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer (NCT NCT00753545)
NCT ID: NCT00753545
Last Updated: 2025-02-03
Results Overview
PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Results posted on
2025-02-03
Participant Flow
The first patient was enrolled on 28 August 2008 and the last patient was enrolled on 9 February 2010. Patients were enrolled at 82 centres in 16 countries. Of the 326 patients enrolled, 265 were randomized
It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who had received 2 or more previous platinum-containing regimens and demonstrated an objective stable maintained response in the last platinum regimen prior to enrolment were to receive olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.
Participant milestones
| Measure |
Olaparib 400 mg bd
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
129
|
|
Overall Study
COMPLETED
|
28
|
11
|
|
Overall Study
NOT COMPLETED
|
108
|
118
|
Reasons for withdrawal
| Measure |
Olaparib 400 mg bd
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Overall Study
Death
|
98
|
112
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Voluntary Discontinuation of Patient
|
7
|
3
|
Baseline Characteristics
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Time to progression
>6 to 12 months
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Time to progression
>12 months
|
83 participants
n=5 Participants
|
75 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Objective response
Complete response
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Objective response
Partial response
|
79 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
|
8.4 Months
Interval 7.4 to 11.5
|
4.8 Months
Interval 4.0 to 5.5
|
SECONDARY outcome
Timeframe: Follow up every 12 weeks post progression, assessed maximum up to 90 months.OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Overall Survival (OS)
|
29.8 Months
Interval 26.9 to 35.7
|
27.8 Months
Interval 24.9 to 33.7
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.Population: Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline
For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
Outcome measures
| Measure |
Olaparib 400 mg bd
n=57 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=48 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Objective Response Rate (ORR) (According to RECIST)
|
12.3 percentage of participants
|
4.2 percentage of participants
|
SECONDARY outcome
Timeframe: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. \[FAS\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Disease Control Rate
|
53.7 percentage of participants
|
25.6 percentage of participants
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. \[Responding patients only\]. There were insufficient responses to enable conclusions to be drawn.
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Duration of Response
|
4.2 Months
Interval 2.8 to 5.6
|
2.3 Months
Interval 1.8 to 2.8
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.Population: Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.
Percentage change from baseline to Week 24 in target tumour size.
Outcome measures
| Measure |
Olaparib 400 mg bd
n=56 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=47 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Percentage Change From Baseline in Tumour Size at Week 24
|
-0.8 Percent change in tumour size
Interval -100.0 to 45.0
|
26.4 Percent change in tumour size
Interval -36.4 to 39.4
|
SECONDARY outcome
Timeframe: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.Population: A subset of the FAS with baseline and at least 1 follow-up value of CA-125
Best percentage change from baseline in CA-125 level
Outcome measures
| Measure |
Olaparib 400 mg bd
n=135 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=128 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
|
-16.67 percentage of change
Interval -100.0 to 346.15
|
0.00 percentage of change
Interval -99.5 to 1436.84
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.Best overall response from radiologic assessments. \[FAS\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Best Objective Response
Complete Response
|
0 Participants
|
0 Participants
|
|
Best Objective Response
Partial Response
|
7 Participants
|
2 Participants
|
|
Best Objective Response
No evidence of disease
|
49 Participants
|
42 Participants
|
|
Best Objective Response
Stable Disease >= 11 weeks
|
46 Participants
|
25 Participants
|
|
Best Objective Response
Disease Progression
|
24 Participants
|
55 Participants
|
|
Best Objective Response
Not Evaluable
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.RECIST and CA-125 response separately and combined \[Patients evaluable for either CA-125 response or RECIST response\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=61 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=53 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
RECIST and CA-125 Response Separately and Combined
RECIST Response
|
16 Participants
|
2 Participants
|
|
RECIST and CA-125 Response Separately and Combined
Confirmed RECIST Response
|
7 Participants
|
2 Participants
|
|
RECIST and CA-125 Response Separately and Combined
Unconfirmed RECIST response
|
9 Participants
|
0 Participants
|
|
RECIST and CA-125 Response Separately and Combined
CA-125 Response
|
1 Participants
|
1 Participants
|
|
RECIST and CA-125 Response Separately and Combined
Confirmed RECIST or CA-125 Response
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. \[FAS\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=136 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=129 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Time to Earlier of CA-125 or RECIST Progression
|
8.3 Months
Interval 5.5 to 10.3
|
3.7 Months
Interval 2.8 to 4.5
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.Population: Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. \[Evaluable for FOSI set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=117 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=115 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Improvement Rate for FACT-O Symptom Index (FOSI)
|
17.1 percentage of evaluable participants
|
14.8 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.Population: Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. \[Evaluable for TOI set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=115 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=111 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Improvement Rate for Trial Outcome Index (TOI)
|
20.0 percentage of evaluable participants
|
18.0 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.Population: Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. \[Evaluable for FACT-O set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=114 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=111 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
|
21.1 percentage of evaluable participants
|
18.9 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FOSI set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=117 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=115 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
FACT-O Symptom Index (FOSI) Time to Worsening
|
2.8 Months
Interval 1.8 to 3.7
|
3.7 Months
Interval 3.3 to 5.6
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for TOI set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=115 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=111 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Trial Outcome Index(TOI)Time to Worsening
|
3.8 Months
Interval 2.8 to 7.4
|
4.6 Months
Interval 3.7 to 7.4
|
SECONDARY outcome
Timeframe: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FACT-O set\]
Outcome measures
| Measure |
Olaparib 400 mg bd
n=114 Participants
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
|
Placebo bd
n=111 Participants
olaparib matching placebo oral capsules twice daily
|
|---|---|---|
|
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
|
2.8 Months
Interval 1.9 to 4.7
|
4.6 Months
Interval 3.6 to 5.5
|
Adverse Events
Olaparib 400 mg bd
Serious events: 31 serious events
Other events: 129 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olaparib 400 mg bd
n=136 participants at risk
|
Placebo
n=128 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.2%
3/136 • Number of events 3
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.5%
2/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL INCARCERATED HERNIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.5%
2/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
1.6%
2/128 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
MELAENA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
NAUSEA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.5%
2/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
2.3%
3/128 • Number of events 4
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
VOMITING
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
HERNIA PAIN
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
PYREXIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Immune system disorders
IODINE ALLERGY
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
APPENDICITIS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
ENDOPHTHALMITIS
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
LIVER ABSCESS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
PNEUMONIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
1.5%
2/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LEUKAEMIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
APHASIA
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
SYNCOPE
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.5%
2/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.74%
1/136 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Vascular disorders
ESSENTIAL HYPERTENSION
|
0.00%
0/136
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.78%
1/128 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.74%
1/136 • Number of events 1
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
0.00%
0/128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
Other adverse events
| Measure |
Olaparib 400 mg bd
n=136 participants at risk
|
Placebo
n=128 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
19.1%
26/136 • Number of events 32
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
5.5%
7/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.1%
7/136 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.9%
5/128 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
4.4%
6/136 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
5.5%
7/128 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
15.4%
21/136 • Number of events 24
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
8.6%
11/128 • Number of events 13
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.7%
35/136 • Number of events 44
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
26.6%
34/128 • Number of events 51
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
5.1%
7/136 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
7.8%
10/128 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
18.4%
25/136 • Number of events 28
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
8.6%
11/128 • Number of events 11
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.1%
30/136 • Number of events 41
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
10.9%
14/128 • Number of events 15
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
26.5%
36/136 • Number of events 62
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
24.2%
31/128 • Number of events 39
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
DYSPEPSIA
|
19.9%
27/136 • Number of events 34
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
8.6%
11/128 • Number of events 11
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
NAUSEA
|
70.6%
96/136 • Number of events 128
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
35.9%
46/128 • Number of events 58
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
STOMATITIS
|
8.8%
12/136 • Number of events 15
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.1%
4/128 • Number of events 4
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Gastrointestinal disorders
VOMITING
|
34.6%
47/136 • Number of events 91
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
14.1%
18/128 • Number of events 20
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
ASTHENIA
|
14.0%
19/136 • Number of events 26
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
9.4%
12/128 • Number of events 15
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
FATIGUE
|
53.7%
73/136 • Number of events 92
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
39.1%
50/128 • Number of events 57
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
OEDEMA PERIPHERAL
|
8.8%
12/136 • Number of events 14
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
4.7%
6/128 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
General disorders
PYREXIA
|
9.6%
13/136 • Number of events 16
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.1%
4/128 • Number of events 4
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
NASOPHARYNGITIS
|
15.4%
21/136 • Number of events 26
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
10.9%
14/128 • Number of events 17
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.2%
18/136 • Number of events 24
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
6.2%
8/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.0%
15/136 • Number of events 21
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
4.7%
6/128 • Number of events 6
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.6%
9/136 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
1.6%
2/128 • Number of events 2
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
21.3%
29/136 • Number of events 34
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
13.3%
17/128 • Number of events 22
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.9%
8/136 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
7.0%
9/128 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
17.6%
24/136 • Number of events 36
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
14.1%
18/128 • Number of events 19
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
18.4%
25/136 • Number of events 37
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
10.9%
14/128 • Number of events 16
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.6%
13/136 • Number of events 20
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.9%
5/128 • Number of events 5
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.4%
10/136 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
6.2%
8/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.1%
7/136 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
6.2%
8/128 • Number of events 9
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.8%
12/136 • Number of events 16
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
5.5%
7/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
DIZZINESS
|
15.4%
21/136 • Number of events 28
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
7.0%
9/128 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
DYSGEUSIA
|
16.2%
22/136 • Number of events 26
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
6.2%
8/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
HEADACHE
|
21.3%
29/136 • Number of events 47
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
13.3%
17/128 • Number of events 20
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
8.8%
12/136 • Number of events 13
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
2.3%
3/128 • Number of events 5
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Nervous system disorders
PARAESTHESIA
|
5.1%
7/136 • Number of events 9
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
2.3%
3/128 • Number of events 5
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Psychiatric disorders
ANXIETY
|
5.9%
8/136 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.9%
5/128 • Number of events 6
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Psychiatric disorders
DEPRESSION
|
8.1%
11/136 • Number of events 11
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
7.0%
9/128 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Psychiatric disorders
INSOMNIA
|
6.6%
9/136 • Number of events 9
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
7.0%
9/128 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.9%
23/136 • Number of events 33
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
10.2%
13/128 • Number of events 14
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.5%
17/136 • Number of events 20
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
6.2%
8/128 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.2%
3/136 • Number of events 3
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
5.5%
7/128 • Number of events 7
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.9%
8/136 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
2.3%
3/128 • Number of events 3
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.9%
8/136 • Number of events 8
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
9.4%
12/128 • Number of events 13
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Vascular disorders
HOT FLUSH
|
3.7%
5/136 • Number of events 6
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
12.5%
16/128 • Number of events 18
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
|
Vascular disorders
HYPERTENSION
|
7.4%
10/136 • Number of events 10
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
3.1%
4/128 • Number of events 4
128 participants in Placebo as 1 participant withdrew consent prior to treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60