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NCT02039947 · ADVERSE EVENTS

Adverse events

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain · Source last updated 2019-05-21

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
every 12 weeks until death up to 4 years
Other-event reporting threshold
5%

AE additional description

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A

Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.

26 / 7674 / 7654 / 76
Cohort B

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

5 / 1616 / 1610 / 16
Cohort C

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

4 / 1616 / 1615 / 16
Cohort D

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

9 / 1717 / 1713 / 17
Total

Total

44 / 125123 / 12592 / 125

Group identifiers: EG000: Cohort A · EG001: Cohort B · EG002: Cohort C · EG003: Cohort D · EG004: Total

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
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardio-respiratory arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardiomyopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Myocardial ischaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Myocarditis
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Pericardial effusion
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Tachyarrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Detachment of retinal pigment epithelium
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Macular detachment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Abdominal pain

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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      125
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      125
    term
    Lymphopenia
  3. 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
      76
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      125
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      125
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cyanosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Ear pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      125
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Asthenopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Conjunctival irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      125
    term
    Diplopia
Complete source fields
description
AE additional description
event Groups
  1. deaths Num Affected
    54
    deaths Num At Risk
    76
    description
    Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
    id
    EG000
    other Num Affected
    74
    other Num At Risk
    76
    serious Num Affected
    26
    serious Num At Risk
    76
    title
    Cohort A
  2. deaths Num Affected
    10
    deaths Num At Risk
    16
    description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    5
    serious Num At Risk
    16
    title
    Cohort B
  3. deaths Num Affected
    15
    deaths Num At Risk
    16
    description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    4
    serious Num At Risk
    16
    title
    Cohort C
  4. deaths Num Affected
    13
    deaths Num At Risk
    17
    description
    Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
    id
    EG003
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    Cohort D
  5. deaths Num Affected
    92
    deaths Num At Risk
    125
    description
    Total
    id
    EG004
    other Num Affected
    123
    other Num At Risk
    125
    serious Num Affected
    44
    serious Num At Risk
    125
    title
    Total
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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      125
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      125
    term
    Lymphopenia
  3. 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
      76
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      125
    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
      4
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      125
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cyanosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Ear pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      125
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Asthenopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Conjunctival irritation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      125
    term
    Diplopia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      125
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardio-respiratory arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Cardiomyopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Myocardial ischaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Myocarditis
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Pericardial effusion
  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
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Tachyarrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Detachment of retinal pigment epithelium
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Macular detachment
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      76
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      125
    term
    Abdominal pain
time Frame
every 12 weeks until death up to 4 years

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

Preserved source evidence · Not medical advice