TriangleNCT03011372 · OUTCOME
Duration of Complete Response
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 2513 days (120 21-day treatment cycles)
What was measured
Duration of complete response was defined as the time from the first assessment of complete response to the earlier of the date of first worsening assessment after complete response or death due to any cause
Analysis population: Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method.
Groups in this outcome
Pemigatinib 13.5 mg
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
| Group | Source count |
|---|---|
| Pemigatinib 13.5 mg | 31 |
Reported measurements
Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemigatinib 13.5 mg | 53.29 | Not reported | 12.22 | NA | The upper limit of the confidence interval was not estimable because too few participants had worsening assessment after response or death. |
CRC assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemigatinib 13.5 mg | NA | Not reported | 27.86 | NA | The median and the upper limit of the confidence interval were not estimable because too few participants had worsening assessment after response or death. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had worsening assessment after response or death.
- group Id
- OG000
- lower Limit
- 12.22
- upper Limit
- NA
- value
- 53.29
- title
- Investigator assessment
- categories
- measurements
- comment
- The median and the upper limit of the confidence interval were not estimable because too few participants had worsening assessment after response or death.
- group Id
- OG000
- lower Limit
- 27.86
- upper Limit
- NA
- value
- NA
- title
- CRC assessment
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- Duration of complete response was defined as the time from the first assessment of complete response to the earlier of the date of first worsening assessment after complete response or death due to any cause
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
- id
- OG000
- title
- Pemigatinib 13.5 mg
- param Type
- MEDIAN
- population Description
- Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method.
- reporting Status
- POSTED
- time Frame
- up to 2513 days (120 21-day treatment cycles)
- title
- Duration of Complete Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice