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NCT01844986 · ADVERSE EVENTS

Adverse events

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. · Source last updated 2025-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm.
Other-event reporting threshold
5%

Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Olaparib 300mg Tablets (Global Cohort)

Taken orally twice daily

54 / 260253 / 26055 / 260
Placebo Tablets (Global Cohort)

Taken orally twice daily

16 / 130117 / 13027 / 131
Olaparib 300mg Tablets (China Cohort)

Taken orally twice daily

13 / 4443 / 4410 / 44
Placebo Tablets (China Cohort)

Taken orally twice daily

3 / 2018 / 206 / 20

Group identifiers: EG000: Olaparib 300mg Tablets (Global Cohort) · EG001: Placebo Tablets (Global Cohort) · EG002: Olaparib 300mg Tablets (China Cohort) · EG003: Placebo Tablets (China Cohort)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      260
      num Events
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      44
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Ileus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Incarcerated umbilical hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Intestinal obstruction

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      260
      num Events
      156
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      130
      num Events
      18
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      44
      num Events
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      260
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Palpitations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      44
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      260
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      130
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      4
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      260
      num Events
      86
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      130
      num Events
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      260
      num Events
      50
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      130
      num Events
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      201
      num At Risk
      260
      num Events
      412
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      130
      num Events
      75
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      44
      num Events
      49
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      20
      num Events
      11
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      260
      num Events
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      130
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Toothache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      260
      num Events
      138
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      130
      num Events
      48
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      44
      num Events
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      260
      num Events
      29
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      130
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Influenza like illness
Complete source fields
description
Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
event Groups
  1. deaths Num Affected
    55
    deaths Num At Risk
    260
    description
    Taken orally twice daily
    id
    EG000
    other Num Affected
    253
    other Num At Risk
    260
    serious Num Affected
    54
    serious Num At Risk
    260
    title
    Olaparib 300mg Tablets (Global Cohort)
  2. deaths Num Affected
    27
    deaths Num At Risk
    131
    description
    Taken orally twice daily
    id
    EG001
    other Num Affected
    117
    other Num At Risk
    130
    serious Num Affected
    16
    serious Num At Risk
    130
    title
    Placebo Tablets (Global Cohort)
  3. deaths Num Affected
    10
    deaths Num At Risk
    44
    description
    Taken orally twice daily
    id
    EG002
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    13
    serious Num At Risk
    44
    title
    Olaparib 300mg Tablets (China Cohort)
  4. deaths Num Affected
    6
    deaths Num At Risk
    20
    description
    Taken orally twice daily
    id
    EG003
    other Num Affected
    18
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    Placebo Tablets (China Cohort)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      260
      num Events
      156
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      130
      num Events
      18
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      44
      num Events
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      260
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Palpitations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      44
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      260
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      130
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      4
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      260
      num Events
      86
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      130
      num Events
      28
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      3
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      260
      num Events
      50
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      130
      num Events
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      201
      num At Risk
      260
      num Events
      412
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      130
      num Events
      75
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      44
      num Events
      49
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      20
      num Events
      11
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      260
      num Events
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      130
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      260
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Toothache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      260
      num Events
      138
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      130
      num Events
      48
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      44
      num Events
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      260
      num Events
      29
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      130
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Influenza like illness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      260
      num Events
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      44
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      260
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Ileus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      260
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Incarcerated umbilical hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      260
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Intestinal obstruction
time Frame
All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm.

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