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NCT01891344 · ADVERSE EVENTS

Adverse events

A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) · Source last updated 2023-06-12

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 time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years.
Other-event reporting threshold
5%

If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Adverse Events were monitored/assessed without regard to the subgroups.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 Overall

All patients who participated in Part 1 who received at least one dose of rucaparib

54 / 204203 / 2042 / 204
Part 2 Overall

All patients who participated in Part 2 who received at least one dose of rucaparib

92 / 287285 / 28718 / 287

Group identifiers: EG000: Part 1 Overall · EG001: Part 2 Overall

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 (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      287
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Granulocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Cardiac congestive failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Long QT syndrome congenital

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 (19.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      287
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      287
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      287
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      287
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      287
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      287
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      287
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      287
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    term
    Dyspepsia
Complete source fields
description
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Adverse Events were monitored/assessed without regard to the subgroups.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    204
    description
    All patients who participated in Part 1 who received at least one dose of rucaparib
    id
    EG000
    other Num Affected
    203
    other Num At Risk
    204
    serious Num Affected
    54
    serious Num At Risk
    204
    title
    Part 1 Overall
  2. deaths Num Affected
    18
    deaths Num At Risk
    287
    description
    All patients who participated in Part 2 who received at least one dose of rucaparib
    id
    EG001
    other Num Affected
    285
    other Num At Risk
    287
    serious Num Affected
    92
    serious Num At Risk
    287
    title
    Part 2 Overall
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      287
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      287
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      287
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      287
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      287
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      287
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      287
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      287
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      287
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      287
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Granulocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    term
    Cardiac congestive failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    term
    Long QT syndrome congenital
time Frame
Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years.

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