TriangleNCT01072175 · OUTCOME
Part B: 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 8 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 defined as 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 of possible drug-induced liver injury.
Analysis population: All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib
Groups in this outcome
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 23 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 27 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 94 |
Reported measurements
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 23 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 27 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 93 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 15 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 55 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 93
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 55
- title
- Any SAE
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 94
- 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 defined as 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 of possible drug-induced liver injury.
- groups
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
- id
- OG000
- title
- Part B: Dabrafenib 75 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG001
- title
- Part B: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG002
- title
- Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
- description
- Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
- id
- OG003
- title
- Part B: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
- title
- Part B: 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