TriangleNCT01584648 · OUTCOME
All Collected Deaths
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
- up to 28 days before Day 1 (Screening), up to 77.4 months (on-treatment), up to approximately 6 years (study duration)
What was measured
Pre-treatment deaths were collected from screening visit up to the first day of treatment, for a maximum duration of 28 days. Patients who died during the screening period are considered as screen failure. On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 77.4 months (treatment duration ranged from 0.1 to 76.4 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 6 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.
Analysis population: Clinical database population; all treated patients and patients who died during screening.
Groups in this outcome
Dabrafenib + Trametinib
Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Dabrafenib + Placebo
Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
Crossover Dabrafenib + Trametinib
Crossover Dabrafenib + Trametinib
| Group | Source count |
|---|---|
| Dabrafenib + Trametinib | 210 |
| Dabrafenib + Placebo | 211 |
| Crossover Dabrafenib + Trametinib | 28 |
Reported measurements
Pre-treatment deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
On-treatment deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 29 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 25 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
Post-treatment deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 106 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 121 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 5 | Not reported | Not reported | Not reported | Not reported |
All deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib + Trametinib | 136 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib + Placebo | 146 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Pre-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 0
- title
- On-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 121
- group Id
- OG002
- value
- 5
- title
- Post-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 146
- group Id
- OG002
- value
- 5
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 210
- group Id
- OG001
- value
- 211
- group Id
- OG002
- value
- 28
- units
- Participants
- description
- Pre-treatment deaths were collected from screening visit up to the first day of treatment, for a maximum duration of 28 days. Patients who died during the screening period are considered as screen failure. On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 77.4 months (treatment duration ranged from 0.1 to 76.4 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 6 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.
- groups
- description
- Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Dabrafenib + Trametinib
- description
- Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.
- id
- OG001
- title
- Dabrafenib + Placebo
- description
- Crossover Dabrafenib + Trametinib
- id
- OG002
- title
- Crossover Dabrafenib + Trametinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Clinical database population; all treated patients and patients who died during screening.
- reporting Status
- POSTED
- time Frame
- up to 28 days before Day 1 (Screening), up to 77.4 months (on-treatment), up to approximately 6 years (study duration)
- title
- All Collected Deaths
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice