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NCT01336634 · ADVERSE EVENTS

Adverse events

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer. · Source last updated 2022-04-04

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 reported from first dose of study treatment until end of study treatment plus 30 days, up to approximately 81 months (study treatment with dabrafenib and trametinib ranged from 0.3 to 80.0 months).
Other-event reporting threshold
5%

Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID

Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.

37 / 8482 / 8415 / 84
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD

Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.

38 / 5754 / 5712 / 57
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD

Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.

24 / 3636 / 365 / 36
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD

Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.

9 / 2020 / 204 / 20

Group identifiers: EG000: Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID · EG001: Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD · EG002: Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD · EG003: Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD

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 (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Splenic thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Sinus bradycardia

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 (23.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Atrioventricular block
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Cataract
Complete source fields
description
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    84
    description
    Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
    id
    EG000
    other Num Affected
    82
    other Num At Risk
    84
    serious Num Affected
    37
    serious Num At Risk
    84
    title
    Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
  2. deaths Num Affected
    12
    deaths Num At Risk
    57
    description
    Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
    id
    EG001
    other Num Affected
    54
    other Num At Risk
    57
    serious Num Affected
    38
    serious Num At Risk
    57
    title
    Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  3. deaths Num Affected
    5
    deaths Num At Risk
    36
    description
    Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
    id
    EG002
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    24
    serious Num At Risk
    36
    title
    Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  4. deaths Num Affected
    4
    deaths Num At Risk
    20
    description
    Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    9
    serious Num At Risk
    20
    title
    Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Atrioventricular block
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
    term
    Cataract
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Splenic thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      84
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
    term
    Sinus bradycardia
time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to approximately 81 months (study treatment with dabrafenib and trametinib ranged from 0.3 to 80.0 months).

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

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