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NCT04171700 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes · Source last updated 2023-10-02

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 event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Other-event reporting threshold
3%

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

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

13 / 6363 / 6323 / 63
Rucaparib Cohort B

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

5 / 2019 / 2010 / 20

Group identifiers: EG000: Rucaparib Cohort A · EG001: Rucaparib Cohort B

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
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
  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
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Cardiac arrest
  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
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Abdominal distension
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Large intestinal obstruction
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Nausea
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Obstruction gastric
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Proctalgia

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      20
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
    term
    Vomiting
Complete source fields
description
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    63
    description
    Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
    id
    EG000
    other Num Affected
    63
    other Num At Risk
    63
    serious Num Affected
    13
    serious Num At Risk
    63
    title
    Rucaparib Cohort A
  2. deaths Num Affected
    10
    deaths Num At Risk
    20
    description
    Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Rucaparib Cohort B
frequency Threshold
3
other 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
      20
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      20
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
    term
    Vomiting
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
      3
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
  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
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Cardiac arrest
  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
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Abdominal distension
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Large intestinal obstruction
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Nausea
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Obstruction gastric
  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
      63
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Proctalgia
time Frame
Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.

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