TriangleNCT01072175 · OUTCOME
Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
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 Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
What was measured
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury.
Analysis population: ATP Population
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 15 |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 15 |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 41 |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
Reported measurements
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 15 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 15 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 41 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 38 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 11 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 29 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 30 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 38
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 30
- title
- Any SAE
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 39
- units
- Participants
- description
- An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury.
- groups
- description
- Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG000
- title
- Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG001
- title
- Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part D: Dabrafenib 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG003
- title
- Part D: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ATP Population
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
- title
- Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice