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NCT04607421 · ADVERSE EVENTS

Adverse events

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

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
AEs: From first dose of study treatment (Day 1) up to 28 days post last dose of study treatment (maximum treatment exposure: SIL = 33.9 months, Phase 3 = 37.25 months and cohort 3 =14.1 months; maximum follow-up: SIL = 34.9 months, Phase 3 = 38.25 and, Cohort 3 =15.1 months); All-cause mortality: From randomization through end of the study at PCD cut-off (maximum of 38.25 months)
Other-event reporting threshold
5%

Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. AEs were evaluated on safety analysis set. MedDRA versions used: 26.1 for SLI, and 27.1 for Phase 3, and Cohort 3. All-cause mortality is reported for full analysis set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SLI: Cohort 1 [EC + FOLFIRI]

Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.

14 / 3029 / 3018 / 30
SLI: Cohort 2 [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

12 / 2727 / 2717 / 27
Phase 3: Arm A [EC]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

46 / 153144 / 15392 / 158
Phase 3: Arm B [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

107 / 232232 / 23294 / 236
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.

89 / 229221 / 229148 / 243
Cohort 3: Arm D [EC + FOLFIRI]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.

28 / 7170 / 7111 / 73
Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]

Participants received fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.

25 / 6867 / 6820 / 74

Group identifiers: EG000: SLI: Cohort 1 [EC + FOLFIRI] · EG001: SLI: Cohort 2 [EC + mFOLFOX6] · EG002: Phase 3: Arm A [EC] · EG003: Phase 3: Arm B [EC + mFOLFOX6] · EG004: Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] · EG005: Cohort 3: Arm D [EC + FOLFIRI] · EG006: Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Immune thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Splenic infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Thrombotic microangiopathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Acute coronary syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Angina unstable
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Arteriospasm coronary
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Atrial fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Atrial flutter

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      106
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      57
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      29
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      57
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      17
      num At Risk
      68
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Dry eye
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      68
    term
    Vision blurred
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Visual impairment
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Abdominal discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      68
    term
    Abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      46
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      68
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain lower
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      68
    term
    Abdominal pain upper
Complete source fields
description
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. AEs were evaluated on safety analysis set. MedDRA versions used: 26.1 for SLI, and 27.1 for Phase 3, and Cohort 3. All-cause mortality is reported for full analysis set.
event Groups
  1. deaths Num Affected
    18
    deaths Num At Risk
    30
    description
    Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    EG000
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    14
    serious Num At Risk
    30
    title
    SLI: Cohort 1 [EC + FOLFIRI]
  2. deaths Num Affected
    17
    deaths Num At Risk
    27
    description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    12
    serious Num At Risk
    27
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
  3. deaths Num Affected
    92
    deaths Num At Risk
    158
    description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    EG002
    other Num Affected
    144
    other Num At Risk
    153
    serious Num Affected
    46
    serious Num At Risk
    153
    title
    Phase 3: Arm A [EC]
  4. deaths Num Affected
    94
    deaths Num At Risk
    236
    description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    EG003
    other Num Affected
    232
    other Num At Risk
    232
    serious Num Affected
    107
    serious Num At Risk
    232
    title
    Phase 3: Arm B [EC + mFOLFOX6]
  5. deaths Num Affected
    148
    deaths Num At Risk
    243
    description
    Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
    id
    EG004
    other Num Affected
    221
    other Num At Risk
    229
    serious Num Affected
    89
    serious Num At Risk
    229
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
  6. deaths Num Affected
    11
    deaths Num At Risk
    73
    description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    EG005
    other Num Affected
    70
    other Num At Risk
    71
    serious Num Affected
    28
    serious Num At Risk
    71
    title
    Cohort 3: Arm D [EC + FOLFIRI]
  7. deaths Num Affected
    20
    deaths Num At Risk
    74
    description
    Participants received fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
    id
    EG006
    other Num Affected
    67
    other Num At Risk
    68
    serious Num Affected
    25
    serious Num At Risk
    68
    title
    Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      106
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      57
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      29
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      57
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      17
      num At Risk
      68
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Dry eye
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      68
    term
    Vision blurred
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Visual impairment
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Abdominal discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      68
    term
    Abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      46
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      68
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain lower
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      68
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Immune thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Splenic infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Thrombotic microangiopathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Acute coronary syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Angina unstable
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Arteriospasm coronary
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      68
    term
    Atrial fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      71
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      68
    term
    Atrial flutter
time Frame
AEs: From first dose of study treatment (Day 1) up to 28 days post last dose of study treatment (maximum treatment exposure: SIL = 33.9 months, Phase 3 = 37.25 months and cohort 3 =14.1 months; maximum follow-up: SIL = 34.9 months, Phase 3 = 38.25 and, Cohort 3 =15.1 months); All-cause mortality: From randomization through end of the study at PCD cut-off (maximum of 38.25 months)

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Preserved source evidence · Not medical advice