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NCT02124772 · ADVERSE EVENTS

Adverse events

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14

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
From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months.
Other-event reporting threshold
5%

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

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A - TMT 0.0125 mg/kg/Day

Participants treated with trametinib 0.0125 mg/kg/day

1 / 33 / 30 / 3
Part A - TMT 0.025 mg/kg/Day

Participants treated with trametinib 0.025 mg/kg/day

8 / 1919 / 190 / 19
Part A - TMT 0.032 mg/kg/Day

Participants under 6 years of age treated with trametinib 0.032 mg/kg/day

3 / 1212 / 120 / 12
Part A - TMT 0.04 mg/kg/Day

Participants treated with trametinib 0.04 mg/kg/day

11 / 1616 / 160 / 16
Part B - Neuroblastoma

Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day

6 / 1111 / 110 / 11
Part B - LGG Fusion

Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day

6 / 1010 / 100 / 10
Part B - NF-1 With PN

Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day

6 / 1010 / 100 / 10
Part B - BRAF V600 Mutant Solid Tumor

Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day

5 / 1010 / 100 / 10
Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D

Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)

1 / 33 / 30 / 3
Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D

Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)

5 / 99 / 90 / 9
Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D

Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)

2 / 66 / 60 / 6
Part D - LGG

Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)

8 / 2020 / 200 / 20
Part D - LCH

Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)

6 / 1010 / 100 / 10

Group identifiers: EG000: Part A - TMT 0.0125 mg/kg/Day · EG001: Part A - TMT 0.025 mg/kg/Day · EG002: Part A - TMT 0.032 mg/kg/Day · EG003: Part A - TMT 0.04 mg/kg/Day · EG004: Part B - Neuroblastoma · EG005: Part B - LGG Fusion · EG006: Part B - NF-1 With PN · EG007: Part B - BRAF V600 Mutant Solid Tumor · EG008: Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D · EG009: Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D · EG010: Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D · EG011: Part D - LGG · EG012: Part D - LCH

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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      20
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Anal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Pancreatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Hypothermia

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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      4
      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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Bone marrow oedema
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Eosinophilia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Febrile 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Hypochromasia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Leukocytosis
  7. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Leukopenia
  8. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphadenitis
  9. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphadenopathy
  10. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphopenia
  11. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      20
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
Complete source fields
description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants treated with trametinib 0.0125 mg/kg/day
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part A - TMT 0.0125 mg/kg/Day
  2. deaths Num Affected
    0
    deaths Num At Risk
    19
    description
    Participants treated with trametinib 0.025 mg/kg/day
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    8
    serious Num At Risk
    19
    title
    Part A - TMT 0.025 mg/kg/Day
  3. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Part A - TMT 0.032 mg/kg/Day
  4. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Participants treated with trametinib 0.04 mg/kg/day
    id
    EG003
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    11
    serious Num At Risk
    16
    title
    Part A - TMT 0.04 mg/kg/Day
  5. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Part B - Neuroblastoma
  6. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Participants with recurrent or unresectable low grade glioma (LGG) with BRAF tandem duplication with fusion treated with trametinib 0.025 mg/kg/day
    id
    EG005
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Part B - LGG Fusion
  7. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Part B - NF-1 With PN
  8. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
    id
    EG007
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Part B - BRAF V600 Mutant Solid Tumor
  9. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D
  10. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    EG009
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D
  11. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
    id
    EG010
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D
  12. deaths Num Affected
    0
    deaths Num At Risk
    20
    description
    Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
    id
    EG011
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    8
    serious Num At Risk
    20
    title
    Part D - LGG
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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      4
      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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Bone marrow oedema
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Eosinophilia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Febrile 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Hypochromasia
  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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Leukocytosis
  7. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Leukopenia
  8. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphadenitis
  9. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphadenopathy
  10. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Lymphopenia
  11. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      20
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Thrombocytopenia
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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      20
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Anal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Pancreatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      20
    term
    Hypothermia
time Frame
From the day of the first dose of any study drug up to 30 days after the last dose, up to maximum duration of 64 months.

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

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