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NCT03465722 · ADVERSE EVENTS

Adverse events

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST · Source last updated 2022-10-06

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
From the date of first study drug administration to 30 days after last study drug administration, approximately 6 months
Other-event reporting threshold
5%

The total number of at risk patients includes patients that were randomized to treatment and received at least one dose of treatment. Patients that were randomized by did not receive treatment were excluded from the safety analysis.

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

300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.

106 / 239218 / 23989 / 239
Regorafinib

160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).

91 / 234224 / 23487 / 234

Group identifiers: EG000: Avapritinib · EG001: Regorafinib

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 (18.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Haemolytic uraemic syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Myocarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Ventricular arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Retinal vein occlusion

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
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Periorbital oedema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Lacrimation increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Eyelid oedema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      234
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    Gastrooesophageal reflux disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      234
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      234
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      234
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      234
    term
    Mucosal inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Conjunctivitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    White blood cell count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      234
    term
    Aspartate aminotransferase increased
Complete source fields
description
The total number of at risk patients includes patients that were randomized to treatment and received at least one dose of treatment. Patients that were randomized by did not receive treatment were excluded from the safety analysis.
event Groups
  1. deaths Num Affected
    89
    deaths Num At Risk
    239
    description
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    id
    EG000
    other Num Affected
    218
    other Num At Risk
    239
    serious Num Affected
    106
    serious Num At Risk
    239
    title
    Avapritinib
  2. deaths Num Affected
    87
    deaths Num At Risk
    234
    description
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    id
    EG001
    other Num Affected
    224
    other Num At Risk
    234
    serious Num Affected
    91
    serious Num At Risk
    234
    title
    Regorafinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Periorbital oedema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Lacrimation increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Eyelid oedema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      234
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    Gastrooesophageal reflux disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      234
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      234
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      234
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      234
    term
    Mucosal inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Conjunctivitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    White blood cell count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      234
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Haemolytic uraemic syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Myocarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    Ventricular arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    Retinal vein occlusion
time Frame
From the date of first study drug administration to 30 days after last study drug administration, approximately 6 months

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