TriangleNCT01336634 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events
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 study treatment start date till 30 days safety follow-up, assessed up to approximately 81 months
What was measured
The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Analysis population: All Treated Population (ATP)
Groups in this outcome
Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD
Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
| Group | Source count |
|---|---|
| Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID | 84 |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 57 |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 36 |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 20 |
Reported measurements
Treatment Emergent Adverse Events (TAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID | 82 | Not reported | Not reported | Not reported | Not reported |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 54 | Not reported | Not reported | Not reported | Not reported |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 36 | Not reported | Not reported | Not reported | Not reported |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 20 | Not reported | Not reported | Not reported | Not reported |
Treatment Emergent Serious Adverse Events (TESAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID | 37 | Not reported | Not reported | Not reported | Not reported |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 38 | Not reported | Not reported | Not reported | Not reported |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 24 | Not reported | Not reported | Not reported | Not reported |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 9 | Not reported | Not reported | Not reported | Not reported |
Deaths due to AE causally related to treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 20
- title
- Treatment Emergent Adverse Events (TAEs)
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 9
- title
- Treatment Emergent Serious Adverse Events (TESAEs)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Deaths due to AE causally related to treatment
- denoms
- counts
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 20
- units
- Participants
- description
- The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
- groups
- description
- Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
- id
- OG000
- title
- Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
- description
- Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
- id
- OG001
- title
- Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
- description
- Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
- id
- OG002
- title
- Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
- description
- Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
- id
- OG003
- title
- Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population (ATP)
- reporting Status
- POSTED
- time Frame
- From study treatment start date till 30 days safety follow-up, assessed up to approximately 81 months
- title
- Number of Participants With Treatment Emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice