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NCT01584648 · ADVERSE EVENTS

Adverse events

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma · Source last updated 2021-02-17

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 77.4 months (treatment duration ranged from 0.1 to 76.4 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 + Trametinib

Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.

100 / 209194 / 209135 / 209
Dabrafenib + Placebo

Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

80 / 211200 / 211146 / 211
Crossover Dabrafenib + Trametinib

Crossover Dabrafenib + Trametinib

8 / 2823 / 285 / 28
All Patients

All Patients

183 / 420394 / 420286 / 420

Group identifiers: EG000: Dabrafenib + Trametinib · EG001: Dabrafenib + Placebo · EG002: Crossover Dabrafenib + 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
      5
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      420
    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
      0
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      420
    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
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Haemolytic uraemic syndrome
  4. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Hypochromic anaemia
  5. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Neutropenia
  6. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Pancytopenia
  7. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      420
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      420
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      420
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Cardiovascular insufficiency
  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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Myocardial infarction

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
      16
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      420
    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
      7
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      420
    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
      20
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      420
    term
    Neutropenia
  4. 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
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      420
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      420
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      420
    term
    Tachycardia
  7. 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
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      420
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      420
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      420
    term
    Blepharitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      420
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      420
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      420
    term
    Vision blurred
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
    135
    deaths Num At Risk
    209
    description
    Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    EG000
    other Num Affected
    194
    other Num At Risk
    209
    serious Num Affected
    100
    serious Num At Risk
    209
    title
    Dabrafenib + Trametinib
  2. deaths Num Affected
    146
    deaths Num At Risk
    211
    description
    Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
    id
    EG001
    other Num Affected
    200
    other Num At Risk
    211
    serious Num Affected
    80
    serious Num At Risk
    211
    title
    Dabrafenib + Placebo
  3. deaths Num Affected
    5
    deaths Num At Risk
    28
    description
    Crossover Dabrafenib + Trametinib
    id
    EG002
    other Num Affected
    23
    other Num At Risk
    28
    serious Num Affected
    8
    serious Num At Risk
    28
    title
    Crossover Dabrafenib + Trametinib
  4. deaths Num Affected
    286
    deaths Num At Risk
    420
    description
    All Patients
    id
    EG003
    other Num Affected
    394
    other Num At Risk
    420
    serious Num Affected
    183
    serious Num At Risk
    420
    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
      16
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      420
    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
      7
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      420
    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
      20
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      420
    term
    Neutropenia
  4. 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
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      420
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      420
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      420
    term
    Tachycardia
  7. 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
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      420
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      420
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      420
    term
    Blepharitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      420
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      420
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      420
    term
    Vision blurred
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
      5
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      420
    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
      0
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      420
    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
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Haemolytic uraemic syndrome
  4. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Hypochromic anaemia
  5. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Neutropenia
  6. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Pancytopenia
  7. 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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      420
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      420
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      420
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Cardiovascular insufficiency
  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
      209
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      420
    term
    Myocardial infarction
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 77.4 months (treatment duration ranged from 0.1 to 76.4 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years

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Preserved source evidence · Not medical advice