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NCT02684058 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13

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
On-treatment AEs: from first dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment deaths: from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG).Crossover on-treatment: AEs from first dose to 30 days after last dose of crossover treatment, up to 4.2 years.
Other-event reporting threshold
4.9999%

Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HGG Cohort: Dabrafenib and Trametinib (On-treatment)

AEs collected during on-treatment period with dabrafenib and trametinib in the HGG cohort (up to 30 days post- treatment)

28 / 4141 / 416 / 41
HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)

Deaths collected in the post- treatment follow-up period for participants in the HGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period

0 / 00 / 011 / 13
LGG Cohort: Dabrafenib and Trametinib (On-treatment)

AEs collected during on-treatment period with dabrafenib and trametinib in the LGG cohort (up to 30 days post- treatment)

34 / 7373 / 730 / 73
LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)

Deaths collected in the post- treatment follow-up period for participants in the LGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period

0 / 00 / 00 / 11
LGG Cohort: Carboplatin and Vincristine (On-treatment)

AEs collected during on-treatment period with carboplatin and vincristine in the LGG cohort (up to 30 days post- treatment or start date of crossover treatment, whichever was earlier)

14 / 3333 / 330 / 33
LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up)

Deaths collected in the post- treatment follow-up period (starting from day 31 post- treatment) for participants in the LGG cohort treated with carboplatin and vincristine. No AEs were collected during this period

0 / 00 / 00 / 16
LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment)

AEs collected during crossover on-treatment period with dabrafenib and trametinib for participants in the LGG cohort randomized to carboplatin and vincristine who crossedover to dabrafenib and trametinib after disease progression (up to 30 days post- crossover treatment)

4 / 1211 / 121 / 12
LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up)

Deaths collected in the crossover post- treatment follow-up period (starting from day 31 post- crossover treatment) for participants in the LGG cohort treated with carboplatin and vincristine who crossed over to dabrafenib and trametinib. No AEs were collected during this period

0 / 00 / 00 / 0

Group identifiers: EG000: HGG Cohort: Dabrafenib and Trametinib (On-treatment) · EG001: HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) · EG002: LGG Cohort: Dabrafenib and Trametinib (On-treatment) · EG003: LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) · EG004: LGG Cohort: Carboplatin and Vincristine (On-treatment) · EG005: LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up) · EG006: LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment) · EG007: LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up)

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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    8. group Id
      EG007
      num At Risk
      0
    term
    Ventricular enlargement
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Detachment of retinal pigment epithelium
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Gastrooesophageal reflux disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Pancreatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Upper gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    8. group Id
      EG007
      num At Risk
      0
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Influenza like illness

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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Aortic valve incompetence
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Eyelid ptosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Aphthous ulcer
Complete source fields
description
Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    41
    description
    AEs collected during on-treatment period with dabrafenib and trametinib in the HGG cohort (up to 30 days post- treatment)
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    28
    serious Num At Risk
    41
    title
    HGG Cohort: Dabrafenib and Trametinib (On-treatment)
  2. deaths Num Affected
    11
    deaths Num At Risk
    13
    description
    Deaths collected in the post- treatment follow-up period for participants in the HGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)
  3. deaths Num Affected
    0
    deaths Num At Risk
    73
    description
    AEs collected during on-treatment period with dabrafenib and trametinib in the LGG cohort (up to 30 days post- treatment)
    id
    EG002
    other Num Affected
    73
    other Num At Risk
    73
    serious Num Affected
    34
    serious Num At Risk
    73
    title
    LGG Cohort: Dabrafenib and Trametinib (On-treatment)
  4. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Deaths collected in the post- treatment follow-up period for participants in the LGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)
  5. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    AEs collected during on-treatment period with carboplatin and vincristine in the LGG cohort (up to 30 days post- treatment or start date of crossover treatment, whichever was earlier)
    id
    EG004
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    14
    serious Num At Risk
    33
    title
    LGG Cohort: Carboplatin and Vincristine (On-treatment)
  6. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Deaths collected in the post- treatment follow-up period (starting from day 31 post- treatment) for participants in the LGG cohort treated with carboplatin and vincristine. No AEs were collected during this period
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up)
  7. deaths Num Affected
    1
    deaths Num At Risk
    12
    description
    AEs collected during crossover on-treatment period with dabrafenib and trametinib for participants in the LGG cohort randomized to carboplatin and vincristine who crossedover to dabrafenib and trametinib after disease progression (up to 30 days post- crossover treatment)
    id
    EG006
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment)
  8. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Deaths collected in the crossover post- treatment follow-up period (starting from day 31 post- crossover treatment) for participants in the LGG cohort treated with carboplatin and vincristine who crossed over to dabrafenib and trametinib. No AEs were collected during this period
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up)
frequency Threshold
4.9999
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Aortic valve incompetence
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Eyelid ptosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Angular cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Aphthous ulcer
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    8. group Id
      EG007
      num At Risk
      0
    term
    Ventricular enlargement
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Detachment of retinal pigment epithelium
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Gastrooesophageal reflux disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Pancreatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Upper gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    8. group Id
      EG007
      num At Risk
      0
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      73
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      33
    6. group Id
      EG005
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
    8. group Id
      EG007
      num At Risk
      0
    term
    Influenza like illness
time Frame
On-treatment AEs: from first dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment deaths: from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG).Crossover on-treatment: AEs from first dose to 30 days after last dose of crossover treatment, up to 4.2 years.

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Preserved source evidence · Not medical advice