TriangleNCT02124772 · OUTCOME
Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the day of the first dose of trametinib up to 30 days after the last dose, up to maximum duration of 64 months
What was measured
Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.
Analysis population: All subjects who received at least one dose of trametinib in Part A and B
Groups in this outcome
Part A - TMT 0.0125 mg/kg/Day
Participants treated with trametinib 0.0125 mg/kg/day
Part A - TMT 0.025 mg/kg/Day
Participants treated with trametinib 0.025 mg/kg/day
Part A - TMT 0.032 mg/kg/Day
Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
Part A - TMT 0.04 mg/kg/Day
Participants treated with trametinib 0.04 mg/kg/day
Part B - Neuroblastoma
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
Part B - LGG Fusion
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
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
Part B - BRAF V600 Mutant Solid Tumor
Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
| Group | Source count |
|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 3 |
| Part A - TMT 0.025 mg/kg/Day | 19 |
| Part A - TMT 0.032 mg/kg/Day | 12 |
| Part A - TMT 0.04 mg/kg/Day | 16 |
| Part B - Neuroblastoma | 11 |
| Part B - LGG Fusion | 10 |
| Part B - NF-1 With PN | 10 |
| Part B - BRAF V600 Mutant Solid Tumor | 10 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 19 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 12 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 16 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 11 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 10 | Not reported | Not reported | Not reported | Not reported |
Treatment-related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 19 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 12 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 16 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 10 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 8 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 11 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 5 | Not reported | Not reported | Not reported | Not reported |
Treatment-related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 3 | Not reported | Not reported | Not reported | Not reported |
Fatal SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
AEs leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 4 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 5 | Not reported | Not reported | Not reported | Not reported |
AEs requiring dose interruptions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 12 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 8 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 8 | Not reported | Not reported | Not reported | Not reported |
AEs requiring dose reductions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 9 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 9 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 4 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 7 | Not reported | Not reported | Not reported | Not reported |
AEs requiring dose reductions or interruptions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 13 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 8 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 10
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 10
- title
- Treatment-related AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 5
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- title
- Treatment-related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Fatal SAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- title
- AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 8
- title
- AEs requiring dose interruptions
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 7
- title
- AEs requiring dose reductions
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 9
- title
- AEs requiring dose reductions or interruptions
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.
- groups
- description
- Participants treated with trametinib 0.0125 mg/kg/day
- id
- OG000
- title
- Part A - TMT 0.0125 mg/kg/Day
- description
- Participants treated with trametinib 0.025 mg/kg/day
- id
- OG001
- title
- Part A - TMT 0.025 mg/kg/Day
- description
- Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
- id
- OG002
- title
- Part A - TMT 0.032 mg/kg/Day
- description
- Participants treated with trametinib 0.04 mg/kg/day
- id
- OG003
- title
- Part A - TMT 0.04 mg/kg/Day
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG004
- title
- Part B - Neuroblastoma
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG005
- title
- Part B - LGG Fusion
- description
- Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
- id
- OG006
- title
- Part B - NF-1 With PN
- description
- Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
- id
- OG007
- title
- Part B - BRAF V600 Mutant Solid Tumor
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects who received at least one dose of trametinib in Part A and B
- reporting Status
- POSTED
- time Frame
- From the day of the first dose of trametinib up to 30 days after the last dose, up to maximum duration of 64 months
- title
- Incidence of Treatment Emergent Adverse Events in Subjects Treated With Trametinib Monotherapy
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice