TriangleNCT02052778 · OUTCOME
Phase 2: Overall Survival (OS)
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
- Up to approximately 37.5 months (through cut-off date 29-May-2021)
What was measured
An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
Analysis population: Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.
Groups in this outcome
Phase 2
Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Phase 2 | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 | 20.0 | Not reported | 16.4 | 24.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.4
- upper Limit
- 24.6
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 103
- units
- Participants
- description
- An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Phase 2
- param Type
- MEDIAN
- population Description
- Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.
- reporting Status
- POSTED
- time Frame
- Up to approximately 37.5 months (through cut-off date 29-May-2021)
- title
- Phase 2: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice