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NCT02855944 · ADVERSE EVENTS

Adverse events

ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients · 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 date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years.
Other-event reporting threshold
5%

Adverse events are reported for the Safety Population, defined as patients who received at least one dose of protocol-specified treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rucaparib (Treatment Part)

Patients randomized to the rucaparib arm in the Treatment Part of the study.

66 / 232229 / 23216 / 232
Chemotherapy (Treatment Part)

Patients randomized to the chemotherapy arm in the Treatment Part of the study.

14 / 113109 / 1134 / 113
Rucaparib (Crossover Part)

Patients randomized to chemotherapy who then crossed over upon disease progression and were treated with rucaparib.

24 / 8076 / 803 / 80

Group identifiers: EG000: Rucaparib (Treatment Part) · EG001: Chemotherapy (Treatment Part) · EG002: Rucaparib (Crossover Part)

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 (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      80
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Constipation

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 (23.0)
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      80
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      80
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      80
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      80
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      80
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      80
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      80
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      80
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Dyspepsia
Complete source fields
description
Adverse events are reported for the Safety Population, defined as patients who received at least one dose of protocol-specified treatment.
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    232
    description
    Patients randomized to the rucaparib arm in the Treatment Part of the study.
    id
    EG000
    other Num Affected
    229
    other Num At Risk
    232
    serious Num Affected
    66
    serious Num At Risk
    232
    title
    Rucaparib (Treatment Part)
  2. deaths Num Affected
    4
    deaths Num At Risk
    113
    description
    Patients randomized to the chemotherapy arm in the Treatment Part of the study.
    id
    EG001
    other Num Affected
    109
    other Num At Risk
    113
    serious Num Affected
    14
    serious Num At Risk
    113
    title
    Chemotherapy (Treatment Part)
  3. deaths Num Affected
    3
    deaths Num At Risk
    80
    description
    Patients randomized to chemotherapy who then crossed over upon disease progression and were treated with rucaparib.
    id
    EG002
    other Num Affected
    76
    other Num At Risk
    80
    serious Num Affected
    24
    serious Num At Risk
    80
    title
    Rucaparib (Crossover Part)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      80
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      80
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      80
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      80
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      80
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      80
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      80
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      80
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      80
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Constipation
time Frame
Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years.

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Preserved source evidence · Not medical advice