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NCT01597908 · ADVERSE EVENTS

Adverse events

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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 were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years
Other-event reporting threshold
5%

Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dabrafenib Plus Trametinib

Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.

172 / 350338 / 350216 / 350
Vemurafenib

Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.

139 / 349341 / 349238 / 349
Crossover Dabrafenib Plus Trametinib

With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.

15 / 3432 / 3411 / 34
All Patients

All randomized patients who received at least one dose of study treatment.

319 / 699679 / 699465 / 699

Group identifiers: EG000: Dabrafenib Plus Trametinib · EG001: Vemurafenib · EG002: Crossover Dabrafenib Plus Trametinib · EG003: All Patients

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 (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      699
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      699
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Arteriosclerosis coronary artery
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      699
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Left ventricular dysfunction

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 (19.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      699
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      699
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      699
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      699
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      699
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      699
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      699
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      75
      num At Risk
      699
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      78
      num At Risk
      699
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      89
      num At Risk
      699
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      131
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      268
      num At Risk
      699
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      699
    term
    Dry mouth
Complete source fields
description
Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.
event Groups
  1. deaths Num Affected
    216
    deaths Num At Risk
    350
    description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    EG000
    other Num Affected
    338
    other Num At Risk
    350
    serious Num Affected
    172
    serious Num At Risk
    350
    title
    Dabrafenib Plus Trametinib
  2. deaths Num Affected
    238
    deaths Num At Risk
    349
    description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    EG001
    other Num Affected
    341
    other Num At Risk
    349
    serious Num Affected
    139
    serious Num At Risk
    349
    title
    Vemurafenib
  3. deaths Num Affected
    11
    deaths Num At Risk
    34
    description
    With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
    id
    EG002
    other Num Affected
    32
    other Num At Risk
    34
    serious Num Affected
    15
    serious Num At Risk
    34
    title
    Crossover Dabrafenib Plus Trametinib
  4. deaths Num Affected
    465
    deaths Num At Risk
    699
    description
    All randomized patients who received at least one dose of study treatment.
    id
    EG003
    other Num Affected
    679
    other Num At Risk
    699
    serious Num Affected
    319
    serious Num At Risk
    699
    title
    All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      699
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      699
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      699
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      699
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      699
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      699
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      699
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      75
      num At Risk
      699
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      78
      num At Risk
      699
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      89
      num At Risk
      699
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      131
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      268
      num At Risk
      699
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      699
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      699
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      699
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      699
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Arteriosclerosis coronary artery
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      699
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      699
    term
    Left ventricular dysfunction
time Frame
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years

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

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