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NCT01885195 · ADVERSE EVENTS

Adverse events

MEK162 for Patients With RAS/RAF/MEK Activated Tumors · Source last updated 2021-02-21

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
From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
Other-event reporting threshold
5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Binimetinib (MEK162)

Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.

50 / 110110 / 110Not reported / Not reported

Group identifiers: EG000: Binimetinib (MEK162)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Coagulopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Dilatation ventricular
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal artery occlusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal detachment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal tear
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Vitreous haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      110
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      110
    term
    Small intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      110
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Ascites

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      110
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      110
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      110
    term
    Vision blurred
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      110
    term
    Chorioretinopathy
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      110
    term
    Periorbital oedema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      110
    term
    Visual impairment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      110
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      110
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      110
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      110
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    term
    Dry mouth
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    term
    Dyspepsia
Complete source fields
description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.
event Groups
  1. description
    Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
    id
    EG000
    other Num Affected
    110
    other Num At Risk
    110
    serious Num Affected
    50
    serious Num At Risk
    110
    title
    Binimetinib (MEK162)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      110
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      110
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      110
    term
    Vision blurred
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      110
    term
    Chorioretinopathy
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      110
    term
    Periorbital oedema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      110
    term
    Visual impairment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      110
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      110
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      110
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      110
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    term
    Dry mouth
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      110
    term
    Dyspepsia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Coagulopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Dilatation ventricular
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal artery occlusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal detachment
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Retinal tear
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Vitreous haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      110
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      110
    term
    Small intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      110
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      110
    term
    Ascites
time Frame
From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)

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