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NCT01874353 · ADVERSE EVENTS

Adverse events

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy · Source last updated 2026-07-29

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
Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Olaparib 300 Tablets (Global Cohort)

Taken orally twice daily

50 / 195192 / 195116 / 196
Placebo Tablets (Global Cohort)

Taken orally twice daily

8 / 9991 / 9965 / 99
Olaparib 300 Tablets (China Cohort)

Taken orally twice daily

5 / 2221 / 2213 / 22
Placebo Tablets (China Cohort)

Taken orally twice daily

1 / 1010 / 107 / 10

Group identifiers: EG000: Olaparib 300 Tablets (Global Cohort) · EG001: Placebo Tablets (Global Cohort) · EG002: Olaparib 300 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 22.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      195
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Coronary artery stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Food poisoning
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      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 22.1
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      195
      num Events
      149
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      99
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      195
      num Events
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      195
      num Events
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      22
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      195
      num Events
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      195
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      195
      num Events
      90
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      99
      num Events
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      195
      num Events
      27
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      99
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      195
      num Events
      65
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      99
      num Events
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      195
      num Events
      128
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      99
      num Events
      28
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      195
      num Events
      19
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      195
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      195
      num Events
      15
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Gastrooesophageal reflux disease
Complete source fields
event Groups
  1. deaths Num Affected
    116
    deaths Num At Risk
    196
    description
    Taken orally twice daily
    id
    EG000
    other Num Affected
    192
    other Num At Risk
    195
    serious Num Affected
    50
    serious Num At Risk
    195
    title
    Olaparib 300 Tablets (Global Cohort)
  2. deaths Num Affected
    65
    deaths Num At Risk
    99
    description
    Taken orally twice daily
    id
    EG001
    other Num Affected
    91
    other Num At Risk
    99
    serious Num Affected
    8
    serious Num At Risk
    99
    title
    Placebo Tablets (Global Cohort)
  3. deaths Num Affected
    13
    deaths Num At Risk
    22
    description
    Taken orally twice daily
    id
    EG002
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    5
    serious Num At Risk
    22
    title
    Olaparib 300 Tablets (China Cohort)
  4. deaths Num Affected
    7
    deaths Num At Risk
    10
    description
    Taken orally twice daily
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    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 22.1
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      195
      num Events
      149
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      99
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      22
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      195
      num Events
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      195
      num Events
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      22
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      195
      num Events
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      195
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      195
      num Events
      90
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      99
      num Events
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      195
      num Events
      27
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      99
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      195
      num Events
      65
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      99
      num Events
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      195
      num Events
      128
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      99
      num Events
      28
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      195
      num Events
      19
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      195
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      195
      num Events
      15
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      195
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Coronary artery stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      195
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      195
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Food poisoning
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      195
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Intestinal obstruction
time Frame
Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice