Trial Outcomes & Findings for Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (NCT NCT03402841)

Last Updated: 2024-08-21

Results Overview

PFS is defined as the time from date of first dose until the date of objective radiological disease progression. Assessed according to modified Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. Confidence intervals (CI) for median PFS was derived based on Brookmeyer-Crowley method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

279 participants

Primary outcome timeframe

Up to maximum of 32 months

Results posted on

2024-08-21

Participant Flow

This was a Phase IIIb, single-arm, open-label multicentre study to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in eligible patients. A total of 279 patients from 17 countries were enrolled in this study.

Olaparib was administered to all patients at a starting dose of 300 milligrams (mg) twice daily. Dose reductions were required in patients experiencing toxicities or due to concomitant medication (CM).

Participant milestones

Participant milestones
Measure	Olaparib Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Overall Study STARTED	279
Overall Study COMPLETED	128
Overall Study NOT COMPLETED	151

Reasons for withdrawal

Reasons for withdrawal
Measure	Olaparib Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	2
Overall Study Death	146

Baseline Characteristics

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Age, Continuous	64.0 years STANDARD_DEVIATION 9.19 • n=5 Participants
Age, Customized <50 years	22 Participants n=5 Participants
Age, Customized >=50 - <65 years	110 Participants n=5 Participants
Age, Customized >=65 - <75 years	113 Participants n=5 Participants
Age, Customized >=75 years	34 Participants n=5 Participants
Sex: Female, Male Female	279 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	273 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	2 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	271 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to maximum of 32 months

Population: The FAS included all enrolled patients assigned to olaparib.

Outcome measures

Outcome measures
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Progression Free Survival (PFS)	9.2 months Interval 7.6 to 10.9

SECONDARY outcome

Timeframe: Up to a maximum of 43 months

Population: The FAS included all enrolled patients assigned to olaparib.

TFST is defined as the time from date of first dose to date of first subsequent treatment commencement or death due to any cause if this occurs before commencement of first subsequent treatment. Calculated using the Kaplan-Meier technique. CI for median TFST was derived based on Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Time to First Subsequent Therapy or Death (TFST)	13.9 months Interval 11.5 to 16.6

SECONDARY outcome

Timeframe: Up to a maximum of 43 months

Population: The FAS included all enrolled patients assigned to olaparib.

TDT is defined as the time from date of first dose to date of study drug discontinuation or death due to any cause if this occurs before study drug discontinuation. Calculated using the Kaplan-Meier technique. CI for median TDT was derived based on Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Time to Treatment Discontinuation or Death (TDT)	9.6 months Interval 7.8 to 11.1

SECONDARY outcome

Timeframe: Up to maximum of 32 months

Population: The FAS included all enrolled patients assigned to Olaparib. Only FAS patients with available central assessment are reported.

HRD/BRCAm status was based on the central blood and tumour assessments. Assessed according to modified RECIST 1.1 or death (by any cause in the absence of progression). Progression was determined by investigator assessment, RECIST 1.1. Calculated using the Kaplan-Meier technique. CI for median PFS was derived based on Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Olaparib n=242 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status HRD status positive and/or sBRCAm subgroup	11.1 months Interval 9.2 to 14.6
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status HRD status positive, non-BRCAm subgroup	9.7 months Interval 8.1 to 13.6
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status HRD status negative subgroup	7.3 months Interval 5.5 to 9.0
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status sBRCAm subgroup	16.4 months Interval 12.8 to The upper CI was not calculable due to insufficient progression events.
PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status gBRCAm subgroup	12.1 months Interval 3.7 to The upper CI was not calculable due to insufficient progression events.

SECONDARY outcome

Timeframe: Up to a maximum of 43 months

Population: The FAS included all enrolled patients assigned to olaparib.

CT-FI is defined as the time from the date of the last dose of platinum chemotherapy prior to olaparib maintenance therapy until the date of initiation of the next anticancer therapy. Calculated using the Kaplan-Meier technique. CI for median CT-FI was derived based on Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Chemotherapy-free Interval (CT-FI)	17.9 months Interval 13.8 to 23.3

SECONDARY outcome

Timeframe: Up to a maximum of 43 months

Population: The FAS included all enrolled patients assigned to olaparib.

OS is defined as the time from the date of first dose of olaparib to the date of death from any cause. Calculated using the Kaplan-Meier technique. CI for median OS was derived based on Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Olaparib n=279 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Overall Survival (OS)	32.7 months Interval 29.5 to 35.3

SECONDARY outcome

Timeframe: Baseline up to a maximum of 32 months

Population: The FACT-O set consisted of all FAS patients with at least a baseline and a post-baseline assessment (excluding the end of treatment and 30-day follow up assessments).

Improvement was defined as a functional assessment of cancer therapy - ovarian (FACT-O) TOI response of "any improvement" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better health related quality of life (HRQoL). An increase in score from baseline indicates an improvement in HRQoL.

Outcome measures

Outcome measures
Measure	Olaparib n=249 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period	64.3 percentage of patients Interval 58.0 to 70.2

SECONDARY outcome

Timeframe: Baseline up to a maximum of 32 months

Population: The FACT-O set consisted of all FAS patients with at least a baseline and a post-baseline assessment (excluding the end of treatment and 30-day follow up assessments).

10-point deterioration was defined as a FACT-O TOI response of "10-point deterioration" at any time point over the course of treatment. The TOI is an established single targeted index composed of the following scales of the FACT-O: physical and functional well-being and additional concerns. The range of possible scores for the FACT-O TOI is 0-100, with a higher score indicating better HRQoL. A decrease in score of at least 10 points from baseline was defined as a clinically meaningful deterioration.

Outcome measures

Outcome measures
Measure	Olaparib n=249 Participants Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period	42.6 percentage of patients Interval 36.3 to 49.0

Adverse Events

Olaparib 300mg BID

Serious events: 58 serious events

Other events: 268 other events

Deaths: 146 deaths

Serious adverse events

Serious adverse events
Measure	Olaparib 300mg BID n=279 participants at risk Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Blood and lymphatic system disorders Thrombocytopenia	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Biliary dyskinesia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Cholecystitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Appendicitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Bacteraemia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Covid-19	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Endocarditis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Cardiac disorders Myocardial infarction	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Gastroenteritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Lower respiratory tract infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pneumonia	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pneumonia aspiration	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Sepsis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Urinary tract infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Ankle fracture	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Fall	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Femur fracture	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Toxicity to various agents	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood creatinine increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Anaemia	7.9% 22/279 • Number of events 31 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Dehydration	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hyponatraemia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Epilepsy	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Depression	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Acute kidney injury	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal incarcerated hernia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Aortic embolus	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Haemorrhage	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Pelvic venous thrombosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Colitis ischaemic	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Constipation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Dyspepsia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Gastrointestinal wall thickening	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Intestinal obstruction	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Large intestinal obstruction	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Mechanical ileus	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Pancreatitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Pneumoperitoneum	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Small intestinal obstruction	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Subileus	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Vomiting	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.

Other adverse events

Other adverse events
Measure	Olaparib 300mg BID n=279 participants at risk Olaparib was administered to all patients at a starting dose of 300 mg twice daily. Dose reductions were required in patients experiencing toxicities or due to CM. Patients continued with olaparib until documented disease progression as assessed by the Investigator or unacceptable toxicity or for as long as they did not meet any other discontinuation criteria.
Cardiac disorders Angina pectoris	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Hyperbilirubinaemia	0.72% 2/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Thrombocytopenia	7.2% 20/279 • Number of events 31 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Peripheral swelling	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Pyrexia	5.7% 16/279 • Number of events 23 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Swelling	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Bile duct stenosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Hepatic cytolysis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Hepatotoxicity	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Hepatobiliary disorders Liver disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Abscess limb	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Atypical mycobacterial lower respiratory tract infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Bacterial infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Bronchitis	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Covid-19	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Candida infection	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Cellulitis	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Cardiac disorders Arrhythmia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Clostridium difficile infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Conjunctivitis viral	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Cystitis	3.6% 10/279 • Number of events 15 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Device related infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Diverticulitis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Ear infection	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Enteritis infectious	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Erysipelas	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Escherichia urinary tract infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Eye infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Fungal infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Gastroenteritis norovirus	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Gastrointestinal infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Gingivitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Herpes simplex	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Influenza	2.2% 6/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Laryngitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Cardiac disorders Palpitations	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Lower respiratory tract infection	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Nail infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Nasopharyngitis	5.4% 15/279 • Number of events 17 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Oral candidiasis	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Oral herpes	0.36% 1/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Otitis media	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Paronychia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pharyngitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pharyngitis streptococcal	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pneumonia	2.2% 6/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Cardiac disorders Tachycardia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pneumonia viral	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Pulpitis dental	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Respiratory tract infection	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Respiratory tract infection viral	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Rhinitis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Salmonellosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Sinusitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Skin infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Ear and labyrinth disorders Deafness	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Tooth abscess	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Tooth infection	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Upper respiratory tract infection	4.3% 12/279 • Number of events 12 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Urethritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Urinary tract infection	9.7% 27/279 • Number of events 36 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Viral infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Infections and infestations Wound infection	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Arthropod bite	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Arthropod sting	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Ear and labyrinth disorders Ear haemorrhage	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Bone fissure	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Contusion	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Fall	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Hand fracture	0.72% 2/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Head injury	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Humerus fracture	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Joint injury	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Procedural pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Ear and labyrinth disorders Meniere's disease	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Rib fracture	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Soft tissue injury	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Tooth fracture	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Injury, poisoning and procedural complications Wound complication	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Alanine aminotransferase increased	2.2% 6/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Amylase increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Aspartate aminotransferase increased	2.5% 7/279 • Number of events 9 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood alkaline phosphatase increased	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Ear and labyrinth disorders Tinnitus	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood bilirubin increased	1.4% 4/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood creatine increased	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood creatinine increased	10.4% 29/279 • Number of events 46 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood potassium decreased	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood potassium increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood pressure decreased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood sodium decreased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Blood urea increased	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Creatinine renal clearance decreased	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Gamma-glutamyltransferase increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Anaemia	36.6% 102/279 • Number of events 197 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Ear and labyrinth disorders Vertigo	1.4% 4/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Glomerular filtration rate decreased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Haemoglobin decreased	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Lipase increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Lymphocyte count decreased	1.4% 4/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Mean cell volume increased	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Monocyte count increased	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Neutrophil count decreased	5.0% 14/279 • Number of events 32 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Occult blood	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Platelet count decreased	5.7% 16/279 • Number of events 33 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Sars-cov-2 test positive	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Endocrine disorders Hypothyroidism	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Troponin i increased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Urine analysis abnormal	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Vitamin b12 decreased	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Weight decreased	2.2% 6/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations Weight increased	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Investigations White blood cell count decreased	4.7% 13/279 • Number of events 29 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Decreased appetite	11.5% 32/279 • Number of events 34 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Dehydration	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypercalcaemia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypercholesterolaemia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Amaurosis fugax	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hyperglycaemia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypocalcaemia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypochloraemia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypokalaemia	4.7% 13/279 • Number of events 20 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hypomagnesaemia	2.2% 6/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Hyponatraemia	1.4% 4/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Metabolism and nutrition disorders Vitamin d deficiency	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 26/279 • Number of events 30 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Cataract	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Arthritis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Back pain	9.7% 27/279 • Number of events 30 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Bone pain	0.72% 2/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Coccydynia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Flank pain	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Groin pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Joint effusion	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Joint swelling	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Muscle contracture	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Muscle spasms	5.7% 16/279 • Number of events 16 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Dry eye	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Muscle tightness	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Muscular weakness	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Myalgia	3.6% 10/279 • Number of events 11 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Neck pain	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Osteopenia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Osteoporosis	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 7/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Eye disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Pubic pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Spinal pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Tendonitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Vision blurred	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Ageusia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Amnesia	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Balance disorder	0.36% 1/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Carpal tunnel syndrome	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Disturbance in attention	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Dizziness	6.1% 17/279 • Number of events 22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Dysgeusia	14.3% 40/279 • Number of events 44 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Dyskinesia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Eye disorders Visual impairment	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Epilepsy	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Headache	8.6% 24/279 • Number of events 27 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Hypoaesthesia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Hypotonia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Migraine	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Nerve compression	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Neuropathy peripheral	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Neurotoxicity	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Paraesthesia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Peripheral sensory neuropathy	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal discomfort	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Polyneuropathy	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Presyncope	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Somnolence	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Syncope	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Taste disorder	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Transient ischaemic attack	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Tremor	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Nervous system disorders Trigeminal nerve disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Product Issues Device breakage	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Affect lability	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal distension	4.7% 13/279 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Agitation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Anxiety	2.2% 6/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Bradyphrenia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Depression	2.5% 7/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Genito-pelvic pain/penetration disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Hallucination, visual	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Insomnia	5.0% 14/279 • Number of events 14 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Irritability	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Mood swings	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Panic attack	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Anaemia macrocytic	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal hernia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Restlessness	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Sleep disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Psychiatric disorders Tension	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Acute kidney injury	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Chronic kidney disease	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Dysuria	3.2% 9/279 • Number of events 10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Haematuria	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Hydronephrosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Micturition urgency	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Nephrolithiasis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Nocturia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Pollakiuria	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Polyuria	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Proteinuria	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Renal disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Renal failure	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Renal impairment	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Urinary tract disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Renal and urinary disorders Urinary tract obstruction	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Heavy menstrual bleeding	0.36% 1/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal pain	15.4% 43/279 • Number of events 52 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Pelvic discomfort	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Pelvic pain	1.8% 5/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Vaginal discharge	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Vaginal haemorrhage	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Reproductive system and breast disorders Vulvovaginal pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Asthma	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 31/279 • Number of events 36 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Dry throat	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal pain lower	2.2% 6/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 14/279 • Number of events 15 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Hiccups	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abdominal pain upper	5.7% 16/279 • Number of events 18 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.2% 6/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Productive cough	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.8% 5/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Abnormal faeces	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Alopecia	5.7% 16/279 • Number of events 16 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Cold sweat	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Dry skin	2.2% 6/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Ecchymosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Eczema	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Erythema	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Aerophagia	0.72% 2/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Nail discolouration	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Nail disorder	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Nail ridging	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Night sweats	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Onychoclasis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Pruritus	2.2% 6/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Rash	3.6% 10/279 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Rash erythematous	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Rash macular	0.36% 1/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Angular cheilitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Rosacea	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Sensitive skin	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Skin lesion	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Skin and subcutaneous tissue disorders Urticaria	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Deep vein thrombosis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Embolism	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Flushing	1.4% 4/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Haematoma	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Aphthous ulcer	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Hot flush	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Hypertension	2.5% 7/279 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Hypotension	0.72% 2/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Lymphoedema	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Peripheral coldness	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Vascular disorders Thrombosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Ascites	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Erythropenia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Chronic gastritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Constipation	8.2% 23/279 • Number of events 28 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Defaecation urgency	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Diarrhoea	14.3% 40/279 • Number of events 55 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Dry mouth	2.2% 6/279 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Dyspepsia	5.7% 16/279 • Number of events 18 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Dysphagia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Enteritis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Epigastric discomfort	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Leukopenia	5.4% 15/279 • Number of events 25 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Eructation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Faecal vomiting	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Faeces soft	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Flatulence	2.9% 8/279 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Gastric ulcer	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Gastritis	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.8% 5/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Gingival pain	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Lymphadenopathy	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Haemorrhoids	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Intestinal obstruction	1.1% 3/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Irritable bowel syndrome	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Lip dry	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Mouth ulceration	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Nausea	48.7% 136/279 • Number of events 187 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Odynophagia	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Oesophagitis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Lymphopenia	2.2% 6/279 • Number of events 9 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Oral mucosal exfoliation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Palatal disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Regurgitation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Stomatitis	4.7% 13/279 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Tooth development disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Tooth disorder	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Macrocytosis	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Toothache	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Gastrointestinal disorders Vomiting	16.1% 45/279 • Number of events 68 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Adhesion	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Asthenia	16.5% 46/279 • Number of events 57 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Chest discomfort	1.1% 3/279 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Chest pain	1.4% 4/279 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Chills	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Early satiety	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Face oedema	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Fatigue	29.4% 82/279 • Number of events 103 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
Blood and lymphatic system disorders Neutropenia	11.1% 31/279 • Number of events 62 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Inflammation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Influenza like illness	1.8% 5/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Infusion site extravasation	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Localised oedema	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Malaise	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Mass	0.36% 1/279 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Mucosal inflammation	3.2% 9/279 • Number of events 10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Non-cardiac chest pain	1.8% 5/279 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Oedema	0.72% 2/279 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.
General disorders Oedema peripheral	4.7% 13/279 • Number of events 15 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib, up to a maximum of 43 months Safety Analysis set consisted of all patients in the FAS who received at least 1 dose of olaparib.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place