TriangleNCT02052778 · OUTCOME
Phase 2: Duration of Response (DOR)
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
A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.
Analysis population: Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
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 | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 | 8.31 | Not reported | 2.1 | 24.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 24.8
- value
- 8.31
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- description
- A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.
- 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
- Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 37.5 months (through cut-off date 29-May-2021)
- title
- Phase 2: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice