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NCT03673501 · ADVERSE EVENTS

Adverse events

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib · Source last updated 2026-02-05

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
Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
Other-event reporting threshold
5%

The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.

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

Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles

64 / 223221 / 22390 / 223
Sunitinib

Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.

61 / 221219 / 22195 / 221

Group identifiers: EG000: Ripretinib · EG001: Sunitinib

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
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      221
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
    term
    Small intestinal obstruction

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
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      221
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      221
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      221
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      221
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      221
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      221
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      221
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      221
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      221
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      221
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      221
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      221
    term
    Abdominal pain upper
Complete source fields
description
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
event Groups
  1. deaths Num Affected
    90
    deaths Num At Risk
    223
    description
    Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
    id
    EG000
    other Num Affected
    221
    other Num At Risk
    223
    serious Num Affected
    64
    serious Num At Risk
    223
    title
    Ripretinib
  2. deaths Num Affected
    95
    deaths Num At Risk
    221
    description
    Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
    id
    EG001
    other Num Affected
    219
    other Num At Risk
    221
    serious Num Affected
    61
    serious Num At Risk
    221
    title
    Sunitinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      221
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      221
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      221
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      221
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      221
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      221
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      221
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      221
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      221
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      221
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      221
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      221
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      221
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      223
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
    term
    Small intestinal obstruction
time Frame
Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)

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