TriangleNCT01597908 · 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 81.1 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 81.1 months (treatment duration ranged from 0.1 to 80.1 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 Plus Trametinib
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Vemurafenib
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Crossover Dabrafenib + Trametinib
With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
| Group | Source count |
|---|---|
| Dabrafenib Plus Trametinib | 351 |
| Vemurafenib | 349 |
| Crossover Dabrafenib + Trametinib | 34 |
Reported measurements
Pre-treatment deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib Plus Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
| Vemurafenib | 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 Plus Trametinib | 44 | Not reported | Not reported | Not reported | Not reported |
| Vemurafenib | 47 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 2 | Not reported | Not reported | Not reported | Not reported |
Post-treatment deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib Plus Trametinib | 172 | Not reported | Not reported | Not reported | Not reported |
| Vemurafenib | 191 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 9 | Not reported | Not reported | Not reported | Not reported |
All deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib Plus Trametinib | 216 | Not reported | Not reported | Not reported | Not reported |
| Vemurafenib | 238 | Not reported | Not reported | Not reported | Not reported |
| Crossover Dabrafenib + Trametinib | 11 | 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
- 44
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 2
- title
- On-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 191
- group Id
- OG002
- value
- 9
- title
- Post-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 238
- group Id
- OG002
- value
- 11
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 351
- group Id
- OG001
- value
- 349
- group Id
- OG002
- value
- 34
- 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 81.1 months (treatment duration ranged from 0.1 to 80.1 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
- Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Dabrafenib Plus Trametinib
- description
- Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Vemurafenib
- description
- With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
- 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 81.1 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 · Independent clinical review pending · Not medical advice