Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02908672 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma · Source last updated 2025-07-20

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
Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
Other-event reporting threshold
5%

26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Run-in - Atezo + Cobi + Vem

Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.

21 / 232208 / 2320 / 232
Run-in - Pbo + Cobi + Vem

Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.

50 / 279262 / 27925 / 279
Triple Combination: Pbo + Cobi + Vem

After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.

81 / 279222 / 279149 / 279
Triple Combination: Atezo + Cobi + Vem

After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.

109 / 232226 / 232128 / 232

Group identifiers: EG000: Run-in - Atezo + Cobi + Vem · EG001: Run-in - Pbo + Cobi + Vem · EG002: Triple Combination: Pbo + Cobi + Vem · EG003: Triple Combination: Atezo + Cobi + Vem

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      232
      num Events
      3
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Coronary artery occlusion

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      279
      num Events
      62
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      232
      num Events
      78
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      279
      num Events
      3
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      279
      num Events
      19
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      232
      num Events
      47
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      279
      num Events
      31
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      232
      num Events
      62
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      232
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      279
      num Events
      3
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      279
      num Events
      24
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      232
      num Events
      67
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      232
      num Events
      9
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      279
      num Events
      19
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      279
      num Events
      34
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      232
      num Events
      33
    term
    Central serous chorioretinopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      279
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      279
      num Events
      2
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      232
      num Events
      15
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      279
      num Events
      14
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      232
      num Events
      18
    term
    Uveitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      279
      num Events
      9
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      279
      num Events
      17
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      232
      num Events
      15
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      232
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      279
      num Events
      39
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      232
      num Events
      44
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      232
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      279
      num Events
      29
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      232
      num Events
      23
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      232
      num Events
      10
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      279
      num Events
      21
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      279
      num Events
      24
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      232
      num Events
      36
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      232
      num Events
      90
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      279
      num Events
      131
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      279
      num Events
      186
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      232
      num Events
      196
    term
    Diarrhoea
Complete source fields
description
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    232
    description
    Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.
    id
    EG000
    other Num Affected
    208
    other Num At Risk
    232
    serious Num Affected
    21
    serious Num At Risk
    232
    title
    Run-in - Atezo + Cobi + Vem
  2. deaths Num Affected
    25
    deaths Num At Risk
    279
    description
    Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.
    id
    EG001
    other Num Affected
    262
    other Num At Risk
    279
    serious Num Affected
    50
    serious Num At Risk
    279
    title
    Run-in - Pbo + Cobi + Vem
  3. deaths Num Affected
    149
    deaths Num At Risk
    279
    description
    After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
    id
    EG002
    other Num Affected
    222
    other Num At Risk
    279
    serious Num Affected
    81
    serious Num At Risk
    279
    title
    Triple Combination: Pbo + Cobi + Vem
  4. deaths Num Affected
    128
    deaths Num At Risk
    232
    description
    After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
    id
    EG003
    other Num Affected
    226
    other Num At Risk
    232
    serious Num Affected
    109
    serious Num At Risk
    232
    title
    Triple Combination: Atezo + Cobi + Vem
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      279
      num Events
      62
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      232
      num Events
      78
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      279
      num Events
      3
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      279
      num Events
      19
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      232
      num Events
      47
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      279
      num Events
      31
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      232
      num Events
      62
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      232
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      279
      num Events
      3
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      279
      num Events
      24
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      232
      num Events
      67
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      232
      num Events
      9
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      279
      num Events
      19
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      279
      num Events
      34
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      232
      num Events
      33
    term
    Central serous chorioretinopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      279
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      279
      num Events
      2
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      232
      num Events
      15
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      279
      num Events
      14
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      232
      num Events
      18
    term
    Uveitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      232
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      279
      num Events
      9
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      279
      num Events
      17
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      232
      num Events
      15
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      232
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      279
      num Events
      39
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      232
      num Events
      44
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      232
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      279
      num Events
      11
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      279
      num Events
      29
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      232
      num Events
      23
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      232
      num Events
      10
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      279
      num Events
      21
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      279
      num Events
      24
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      232
      num Events
      36
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      232
      num Events
      90
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      279
      num Events
      131
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      279
      num Events
      186
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      232
      num Events
      196
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      232
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      232
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      279
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      279
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      232
      num Events
      3
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      232
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      279
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      279
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      232
      num Events
      1
    term
    Coronary artery occlusion
time Frame
Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months

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

Preserved source evidence · Not medical advice