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NCT02928224 · ADVERSE EVENTS

Adverse events

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse Events (AE) were collected from initiation of study drug through 30 days after the last dose of study drug. For CSLI: maximum treatment exposure of 280 weeks; for Phase 3- Triplet arm: maximum treatment exposure of 277.4 weeks; for Phase 3- Doublet arm: maximum treatment exposure of 268 weeks; for Phase 3- Control arm: maximum treatment exposure of 108 weeks
Other-event reporting threshold
5%

An AE is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. For non-SAEs and SAEs: safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. For all-cause mortality: FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Combined Safety Lead-in

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

22 / 3736 / 3730 / 37
Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

118 / 222218 / 222209 / 224
Phase 3: Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

91 / 216212 / 216193 / 220
Phase 3: Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

78 / 193187 / 193198 / 221

Group identifiers: EG000: Combined Safety Lead-in · EG001: Phase 3: Triplet Arm · EG002: Phase 3: Doublet Arm · EG003: Phase 3: Control Arm

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      193
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      193
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Gastrointestinal perforation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Ileus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      193
    term
    Intestinal obstruction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      193
    term
    Large intestine perforation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Subileus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Hepatic failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Cardiac arrest
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      193
    term
    Cardio-respiratory arrest

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      150
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      193
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      193
    term
    Dermatitis acneiform
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      193
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      59
      num At Risk
      193
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      193
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      193
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      193
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      56
      num At Risk
      193
    term
    Decreased appetite
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      193
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      193
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      193
    term
    Dry Skin
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      193
    term
    Pyrexia
Complete source fields
description
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. For non-SAEs and SAEs: safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. For all-cause mortality: FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.
event Groups
  1. deaths Num Affected
    30
    deaths Num At Risk
    37
    description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    37
    serious Num Affected
    22
    serious Num At Risk
    37
    title
    Combined Safety Lead-in
  2. deaths Num Affected
    209
    deaths Num At Risk
    224
    description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    EG001
    other Num Affected
    218
    other Num At Risk
    222
    serious Num Affected
    118
    serious Num At Risk
    222
    title
    Phase 3: Triplet Arm
  3. deaths Num Affected
    193
    deaths Num At Risk
    220
    description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    EG002
    other Num Affected
    212
    other Num At Risk
    216
    serious Num Affected
    91
    serious Num At Risk
    216
    title
    Phase 3: Doublet Arm
  4. deaths Num Affected
    198
    deaths Num At Risk
    221
    description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    EG003
    other Num Affected
    187
    other Num At Risk
    193
    serious Num Affected
    78
    serious Num At Risk
    193
    title
    Phase 3: Control Arm
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      150
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      193
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      193
    term
    Dermatitis acneiform
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      193
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      59
      num At Risk
      193
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      193
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      193
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      193
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      56
      num At Risk
      193
    term
    Decreased appetite
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      193
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      193
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      193
    term
    Dry Skin
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      193
    term
    Pyrexia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      193
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      193
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Gastrointestinal perforation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Ileus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      193
    term
    Intestinal obstruction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      193
    term
    Large intestine perforation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      193
    term
    Subileus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Hepatic failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      193
    term
    Cardiac arrest
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      222
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      216
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      193
    term
    Cardio-respiratory arrest
time Frame
Adverse Events (AE) were collected from initiation of study drug through 30 days after the last dose of study drug. For CSLI: maximum treatment exposure of 280 weeks; for Phase 3- Triplet arm: maximum treatment exposure of 277.4 weeks; for Phase 3- Doublet arm: maximum treatment exposure of 268 weeks; for Phase 3- Control arm: maximum treatment exposure of 108 weeks

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice