TriangleNCT01682083 · OUTCOME
Percentage of Participants With Freedom From Relapse (FFR) 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
- Approximately 4 years
What was measured
The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death.
Analysis population: Intent-to-Treat (ITT) Population
Groups in this outcome
Dabrafenib and Trametinib Combination Therapy
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
Dabrafenib and Trametinib Placebos
Subjects received matching placebos orally for 12 months
| Group | Source count |
|---|---|
| Dabrafenib and Trametinib Combination Therapy | 438 |
| Dabrafenib and Trametinib Placebos | 432 |
Reported measurements
Source class 1
Relapsed (event)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy | 163 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib and Trametinib Placebos | 247 | Not reported | Not reported | Not reported | Not reported |
Died (event)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib and Trametinib Placebos | 0 | Not reported | Not reported | Not reported | Not reported |
Censored, follow-up ended at the time of Primary Completion Date
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy | 44 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib and Trametinib Placebos | 36 | Not reported | Not reported | Not reported | Not reported |
Censored, follow-up ongoing at the time of Primary Completion Date
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy | 229 | Not reported | Not reported | Not reported | Not reported |
| Dabrafenib and Trametinib Placebos | 149 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 247
- title
- Relapsed (event)
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Died (event)
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 36
- title
- Censored, follow-up ended at the time of Primary Completion Date
- measurements
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 149
- title
- Censored, follow-up ongoing at the time of Primary Completion Date
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 432
- units
- Participants
- description
- The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death.
- groups
- description
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- id
- OG000
- title
- Dabrafenib and Trametinib Combination Therapy
- description
- Subjects received matching placebos orally for 12 months
- id
- OG001
- title
- Dabrafenib and Trametinib Placebos
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat (ITT) Population
- reporting Status
- POSTED
- time Frame
- Approximately 4 years
- title
- Percentage of Participants With Freedom From Relapse (FFR) Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice