TriangleNCT01072175 · OUTCOME
Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 19 months)
What was measured
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Analysis population: ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.
Groups in this outcome
Part C: Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
Part C: Dabrafenib 150 mg + Trametinib 1 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
Part C: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 54 |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 54 |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 54 |
Reported measurements
Investigator assessed
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 29 |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 27 |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 41 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: Dabrafenib 150 mg | 5.6 | Not reported | 3.9 | 7.4 | Not reported |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 11.1 | Not reported | 7.4 | 13.2 | Not reported |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 10.5 | Not reported | 7.4 | 19.2 | Not reported |
BICR assessed
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 25 |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 22 |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: Dabrafenib 150 mg | 7.6 | Not reported | 4.7 | NA | NA: Not estimable due to insufficient number of participants with events |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 9.5 | Not reported | 5.6 | NA | NA: Not estimable due to insufficient number of participants with events |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | NA | Not reported | 6.7 | NA | NA: Not estimable due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- 7.4
- value
- 5.6
- group Id
- OG001
- lower Limit
- 7.4
- upper Limit
- 13.2
- value
- 11.1
- group Id
- OG002
- lower Limit
- 7.4
- upper Limit
- 19.2
- value
- 10.5
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 41
- units
- Participants
- title
- Investigator assessed
- categories
- measurements
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- NA
- value
- 7.6
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 9.5
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 6.7
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 33
- units
- Participants
- title
- BICR assessed
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 54
- units
- Participants
- description
- Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received dabrafenib 150 mg gelatin capsules BID.
- id
- OG000
- title
- Part C: Dabrafenib 150 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
- id
- OG001
- title
- Part C: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part C: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.
- reporting Status
- POSTED
- time Frame
- First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 19 months)
- title
- Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice