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NCT03973918 · ADVERSE EVENTS

Adverse events

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG · Source last updated 2024-10-31

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
Up to 3 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Patients Treated With Encorafenib or Binimetinib in All Cohorts

Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both. Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors

2 / 55 / 55 / 5

Group identifiers: EG000: Patients Treated With Encorafenib or Binimetinib in All Cohorts

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CPK Increase
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    RIGHT CILIORETINAL ARTERY OCCLUSION
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    eye disorder other

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    DYSPHASIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    ALANINE AMINOTRANSFERASE INCREASED
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    ANEMIA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    ASPARTATE AMINOTRANSFERASE INCREASED
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    BLURRED VISION
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CK SERUM
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    CPK INCREASED
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    DYSURIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    FATIGUE
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    FLOATERS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    INSOMNIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    MUSCULOSKELETAL CONNECTIVE TISSUE DISORDER
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both. Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Patients Treated With Encorafenib or Binimetinib in All Cohorts
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    DYSPHASIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    ALANINE AMINOTRANSFERASE INCREASED
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    ANEMIA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    ASPARTATE AMINOTRANSFERASE INCREASED
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    BLURRED VISION
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CK SERUM
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    term
    CPK INCREASED
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    DYSURIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    FATIGUE
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    FLOATERS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    INSOMNIA
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    MUSCULOSKELETAL CONNECTIVE TISSUE DISORDER
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CPK Increase
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    RIGHT CILIORETINAL ARTERY OCCLUSION
    organ System
    Eye disorders
    source Vocabulary
    CTC AE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    eye disorder other
time Frame
Up to 3 years

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Preserved source evidence · Not medical advice