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NCT02864992 · ADVERSE EVENTS

Adverse events

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) · Source last updated 2026-07-14

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
Time from first treatment up to data cutoff (approximately Month 74)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 & 2: Cohort A + B + C

Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

169 / 337331 / 337200 / 337

Group identifiers: EG000: Part 1 & 2: Cohort A + B + C

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Acute coronary syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Acute myocardial infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      337
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      337
    term
    Cardiac failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiac tamponade
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Cardio-respiratory arrest
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Ischaemic cardiomyopathy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Myocardial infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Myopericarditis

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      337
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      337
    term
    Lacrimation increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      337
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      337
    term
    Abdominal pain upper
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      337
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      337
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      337
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      337
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      337
    term
    Generalised oedema
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      337
    term
    Oedema
Complete source fields
event Groups
  1. deaths Num Affected
    200
    deaths Num At Risk
    337
    description
    Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
    id
    EG000
    other Num Affected
    331
    other Num At Risk
    337
    serious Num Affected
    169
    serious Num At Risk
    337
    title
    Part 1 & 2: Cohort A + B + C
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      337
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      337
    term
    Lacrimation increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      337
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      337
    term
    Abdominal pain upper
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      337
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      337
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      337
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      337
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      337
    term
    Generalised oedema
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      337
    term
    Oedema
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Acute coronary syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Acute myocardial infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      337
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      337
    term
    Cardiac failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiac tamponade
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Cardio-respiratory arrest
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Ischaemic cardiomyopathy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Myocardial infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Myopericarditis
time Frame
Time from first treatment up to data cutoff (approximately Month 74)

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