TriangleNCT02924376 · OUTCOME
Progression-free Survival (PFS)
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 50.17 months
What was measured
PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Analysis population: Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
Groups in this outcome
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A: FGFR2 Rearrangements or Fusions | 108 |
| Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 20 |
| Cohort C: Negative for FGF/FGFR Alterations | 17 |
| Other | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: FGFR2 Rearrangements or Fusions | 7.03 | Not reported | 6.08 | 10.48 | Not reported |
| Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 2.10 | Not reported | 1.18 | 4.86 | Not reported |
| Cohort C: Negative for FGF/FGFR Alterations | 1.51 | Not reported | 1.38 | 1.84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.08
- upper Limit
- 10.48
- value
- 7.03
- group Id
- OG001
- lower Limit
- 1.18
- upper Limit
- 4.86
- value
- 2.10
- group Id
- OG002
- lower Limit
- 1.38
- upper Limit
- 1.84
- value
- 1.51
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG000
- title
- Cohort A: FGFR2 Rearrangements or Fusions
- description
- Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG001
- title
- Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
- description
- Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG002
- title
- Cohort C: Negative for FGF/FGFR Alterations
- description
- Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG003
- title
- Other
- param Type
- MEDIAN
- population Description
- Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
- reporting Status
- POSTED
- time Frame
- up to 50.17 months
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice