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NCT01006980 · ADVERSE EVENTS

Adverse events

A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) · Source last updated 2016-09-28

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

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

Collection time frame
Baseline through the end of study (maximum exposure: 57.07 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vemurafenib

Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit. Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).

165 / 336333 / 336Not reported / Not reported
Dacarbazine

Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch. Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).

52 / 293247 / 293Not reported / Not reported
Vemurafenib After Crossover

Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.

44 / 8483 / 84Not reported / Not reported

Group identifiers: EG000: Vemurafenib · EG001: Dacarbazine · EG002: Vemurafenib After Crossover

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Lymphadenitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac tamponade

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Abdominal Distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      84
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      84
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      84
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      84
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      84
    term
    Asthenia
Complete source fields
event Groups
  1. description
    Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit. Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
    id
    EG000
    other Num Affected
    333
    other Num At Risk
    336
    serious Num Affected
    165
    serious Num At Risk
    336
    title
    Vemurafenib
  2. description
    Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch. Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
    id
    EG001
    other Num Affected
    247
    other Num At Risk
    293
    serious Num Affected
    52
    serious Num At Risk
    293
    title
    Dacarbazine
  3. description
    Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
    id
    EG002
    other Num Affected
    83
    other Num At Risk
    84
    serious Num Affected
    44
    serious Num At Risk
    84
    title
    Vemurafenib After Crossover
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Abdominal Distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      84
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      84
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      84
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      84
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      84
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Lymphadenitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      336
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Cardiac tamponade
time Frame
Baseline through the end of study (maximum exposure: 57.07 months)

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Preserved source evidence · Not medical advice