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NCT01909453 · ADVERSE EVENTS

Adverse events

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

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
Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
Other-event reporting threshold
5%

Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300)

Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

98 / 257252 / 257171 / 257
Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)

Participants received 450 mg of LGX818 orally QD along with 45 mg of MEK162 BID for each 28 day treatment cycle until progressive disease (PD) as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

84 / 192189 / 192136 / 192
Part 1: LGX818 300 mg

Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

71 / 192190 / 192125 / 192
Part 2: LGX818 300 mg

Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

31 / 8482 / 8460 / 84
Part 1: Vemurafenib 960 mg BID

Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

78 / 186185 / 186145 / 186

Group identifiers: EG000: Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300) · EG001: Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) · EG002: Part 1: LGX818 300 mg · EG003: Part 2: LGX818 300 mg · EG004: Part 1: Vemurafenib 960 mg BID

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 v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Lymph node pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Acute coronary syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Acute myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Atrioventricular block first degree
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Bundle branch block left
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Cardiac failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Cardiac hypertrophy

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 v25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      186
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      186
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      186
    term
    Blepharitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      186
    term
    Cataract
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      186
    term
    Dry eye
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Lacrimation increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Macular oedema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Retinal detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Subretinal fluid
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      186
    term
    Vision blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      186
    term
    Visual field defect
Complete source fields
description
Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
event Groups
  1. deaths Num Affected
    171
    deaths Num At Risk
    257
    description
    Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    EG000
    other Num Affected
    252
    other Num At Risk
    257
    serious Num Affected
    98
    serious Num At Risk
    257
    title
    Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300)
  2. deaths Num Affected
    136
    deaths Num At Risk
    192
    description
    Participants received 450 mg of LGX818 orally QD along with 45 mg of MEK162 BID for each 28 day treatment cycle until progressive disease (PD) as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    EG001
    other Num Affected
    189
    other Num At Risk
    192
    serious Num Affected
    84
    serious Num At Risk
    192
    title
    Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
  3. deaths Num Affected
    125
    deaths Num At Risk
    192
    description
    Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    EG002
    other Num Affected
    190
    other Num At Risk
    192
    serious Num Affected
    71
    serious Num At Risk
    192
    title
    Part 1: LGX818 300 mg
  4. deaths Num Affected
    60
    deaths Num At Risk
    84
    description
    Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    EG003
    other Num Affected
    82
    other Num At Risk
    84
    serious Num Affected
    31
    serious Num At Risk
    84
    title
    Part 2: LGX818 300 mg
  5. deaths Num Affected
    145
    deaths Num At Risk
    186
    description
    Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    EG004
    other Num Affected
    185
    other Num At Risk
    186
    serious Num Affected
    78
    serious Num At Risk
    186
    title
    Part 1: Vemurafenib 960 mg BID
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      186
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      186
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      186
    term
    Blepharitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      186
    term
    Cataract
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      186
    term
    Dry eye
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Lacrimation increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Macular oedema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Retinal detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Subretinal fluid
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      186
    term
    Vision blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      186
    term
    Visual field defect
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Lymph node pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Acute coronary syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      186
    term
    Acute myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Atrioventricular block first degree
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Bundle branch block left
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      186
    term
    Cardiac failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      257
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      192
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      192
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      84
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      186
    term
    Cardiac hypertrophy
time Frame
Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)

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Preserved source evidence · Not medical advice