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NCT02184195 · ADVERSE EVENTS

Adverse events

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy · Source last updated 2023-09-13

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
From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).
Other-event reporting threshold
5%

Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Olaparib 300 mg Twice Daily (bd)

Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

28 / 9089 / 9068 / 92
Placebo

Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

10 / 6156 / 6152 / 62

Group identifiers: EG000: Olaparib 300 mg Twice Daily (bd) · EG001: Placebo

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Bartholinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Hypothyroidism
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Decreased appetite
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Hyperglycaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Cerebrovascular accident
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Embolic stroke
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Transient ischaemic attack

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      90
      num Events
      66
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      61
      num Events
      17
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      90
      num Events
      49
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      61
      num Events
      11
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      90
      num Events
      39
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      61
      num Events
      17
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      90
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      61
      num Events
      8
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      90
      num Events
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      61
      num Events
      12
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      90
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      90
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      61
      num Events
      10
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      90
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      2
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      90
      num Events
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      90
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      6
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    Flatulence
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      90
      num Events
      47
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      61
      num Events
      19
    term
    Fatigue
Complete source fields
description
Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
event Groups
  1. deaths Num Affected
    68
    deaths Num At Risk
    92
    description
    Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    90
    serious Num Affected
    28
    serious Num At Risk
    90
    title
    Olaparib 300 mg Twice Daily (bd)
  2. deaths Num Affected
    52
    deaths Num At Risk
    62
    description
    Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    EG001
    other Num Affected
    56
    other Num At Risk
    61
    serious Num Affected
    10
    serious Num At Risk
    61
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      90
      num Events
      66
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      61
      num Events
      17
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      90
      num Events
      49
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      61
      num Events
      11
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      90
      num Events
      39
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      61
      num Events
      17
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      90
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      61
      num Events
      8
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      90
      num Events
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      61
      num Events
      12
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      90
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      90
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      61
      num Events
      10
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      90
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      2
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      90
      num Events
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      90
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      61
      num Events
      6
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      61
      num Events
      4
    term
    Flatulence
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      90
      num Events
      47
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      61
      num Events
      19
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Bartholinitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Hypothyroidism
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Decreased appetite
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Hyperglycaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Cerebrovascular accident
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
    term
    Embolic stroke
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
    term
    Transient ischaemic attack
time Frame
From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).

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