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NCT03353753 · ADVERSE EVENTS

Adverse events

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies · Source last updated 2022-11-21

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
After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Other-event reporting threshold
5%

Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ripretinib

Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

26 / 8584 / 8526 / 85
Placebo

Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

19 / 4342 / 4326 / 43

Group identifiers: EG000: Ripretinib · 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    term
    Abdominal Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      43
    term
    Death
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Cardiac Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Pericardial Effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Duodenal Ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Fecaloma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Gastrointestinal Fistula

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 version 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      43
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      43
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      43
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      43
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    term
    Abdominal Pain (Upper)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    term
    Peripheral Edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Asthenia
Complete source fields
description
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    85
    description
    Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    EG000
    other Num Affected
    84
    other Num At Risk
    85
    serious Num Affected
    26
    serious Num At Risk
    85
    title
    Ripretinib
  2. deaths Num Affected
    26
    deaths Num At Risk
    43
    description
    Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    43
    serious Num Affected
    19
    serious Num At Risk
    43
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      43
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      43
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      43
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      43
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    term
    Abdominal Pain (Upper)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      43
    term
    Peripheral Edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      43
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      43
    term
    Abdominal Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      43
    term
    Death
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Cardiac Failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Pericardial Effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Duodenal Ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      43
    term
    Fecaloma
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      85
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      43
    term
    Gastrointestinal Fistula
time Frame
After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.

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