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NCT01968213 · ADVERSE EVENTS

Adverse events

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) · Source last updated 2023-06-09

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
Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years.
Other-event reporting threshold
5%

Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rucaparib 600 mg Tablets

Taken orally twice daily (continuous 28 day treatment cycles)

91 / 372372 / 3729 / 372
Placebo Tablets

Taken orally twice daily (continuous 28 day treatment cycles)

20 / 189182 / 1892 / 189

Group identifiers: EG000: Rucaparib 600 mg Tablets · EG001: Placebo Tablets

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Diplopia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Abdominal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      189
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Duodenal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Faecaloma

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      189
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      189
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      189
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      189
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      189
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      284
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      189
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      189
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      189
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Mucosal inflammation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      189
    term
    Oedema peripheral
Complete source fields
description
Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    372
    description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    EG000
    other Num Affected
    372
    other Num At Risk
    372
    serious Num Affected
    91
    serious Num At Risk
    372
    title
    Rucaparib 600 mg Tablets
  2. deaths Num Affected
    2
    deaths Num At Risk
    189
    description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    EG001
    other Num Affected
    182
    other Num At Risk
    189
    serious Num Affected
    20
    serious Num At Risk
    189
    title
    Placebo Tablets
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      189
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      189
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      189
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      189
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      189
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      284
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      189
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      189
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      189
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      189
    term
    Mucosal inflammation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      189
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Diplopia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Abdominal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      189
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Duodenal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      372
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    term
    Faecaloma
time Frame
Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years.

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