TriangleNCT02371369 · OUTCOME
Duration of Response (DOR) Based on Tumor Volume Score (TVS)
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
- Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)
What was measured
Duration of response (DOR) based on TVS is defined from the date of the first recorded evidence of response to the first date of documented disease progression.
Analysis population: DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.
Groups in this outcome
Pexidartinib Part 1 and Part 2
Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
Placebo Part 1, Pexidartinib Part 2
Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 41 |
| Placebo Part 1, Pexidartinib Part 2 | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 52.70 | Not reported | 38.60 | NA | Upper limit 95% CI was not estimable due to insufficient number of events. |
| Placebo Part 1, Pexidartinib Part 2 | NA | Not reported | NA | NA | Median and 95% CIs was not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 38.60
- upper Limit
- NA
- value
- 52.70
- comment
- Median and 95% CIs was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- Duration of response (DOR) based on TVS is defined from the date of the first recorded evidence of response to the first date of documented disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
- id
- OG000
- title
- Pexidartinib Part 1 and Part 2
- description
- Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
- id
- OG001
- title
- Placebo Part 1, Pexidartinib Part 2
- param Type
- MEDIAN
- population Description
- DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.
- reporting Status
- POSTED
- time Frame
- Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)
- title
- Duration of Response (DOR) Based on Tumor Volume Score (TVS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice