TriangleNCT03011372 · 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 2513 days (120 21-day treatment cycles)
What was measured
PFS was defined as the time from the first date of taking study drug until the date of disease progression or until death due to any cause, whichever was earlier. Disease progression was defined as the combination of 2 major criteria, 1 major and 2 minor criteria, or 3 minor criteria from the following lists. Major criteria: (1) increase in blast count; (2) evidence of cytogenetic evolution (re-appearance of a previously present or appearance of a new cytogenetic abnormality, or increase in cytogenetic burden of disease); (3) new or worsening extramedullary disease (worsening splenomegaly or extramedullary disease outside of the spleen). Minor criteria: (1) transfusion dependence; (2) significant loss of maximal response on cytopenias ≥50% decrement from maximum remission/response in granulocytes or platelets; (3) reduction in Hgb by ≥1.5g/dL from best response or from baseline as noted on complete blood count; (4) evidence of clonal evolution (molecular).
Analysis population: Full Efficacy-Evaluable Population. The confidence interval was calculated using the Brookmeyer and Crowley's method. Participants who were still alive without experiencing disease progression at the time of analysis were censored at the date of the last response assessment before the cutoff date. Participants who started a new cancer therapy before disease progression were censored at the date of last response assessment before new cancer therapy start.
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 | 45 |
Reported measurements
Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemigatinib 13.5 mg | 73.89 | Not reported | 54.74 | NA | The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death. |
CRC assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemigatinib 13.5 mg | 73.89 | Not reported | 29.17 | NA | The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death.
- group Id
- OG000
- lower Limit
- 54.74
- upper Limit
- NA
- value
- 73.89
- title
- Investigator assessment
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death.
- group Id
- OG000
- lower Limit
- 29.17
- upper Limit
- NA
- value
- 73.89
- title
- CRC assessment
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- description
- PFS was defined as the time from the first date of taking study drug until the date of disease progression or until death due to any cause, whichever was earlier. Disease progression was defined as the combination of 2 major criteria, 1 major and 2 minor criteria, or 3 minor criteria from the following lists. Major criteria: (1) increase in blast count; (2) evidence of cytogenetic evolution (re-appearance of a previously present or appearance of a new cytogenetic abnormality, or increase in cytogenetic burden of disease); (3) new or worsening extramedullary disease (worsening splenomegaly or extramedullary disease outside of the spleen). Minor criteria: (1) transfusion dependence; (2) significant loss of maximal response on cytopenias ≥50% decrement from maximum remission/response in granulocytes or platelets; (3) reduction in Hgb by ≥1.5g/dL from best response or from baseline as noted on complete blood count; (4) evidence of clonal evolution (molecular).
- 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. The confidence interval was calculated using the Brookmeyer and Crowley's method. Participants who were still alive without experiencing disease progression at the time of analysis were censored at the date of the last response assessment before the cutoff date. Participants who started a new cancer therapy before disease progression were censored at the date of last response assessment before new cancer therapy start.
- reporting Status
- POSTED
- time Frame
- up to 2513 days (120 21-day treatment cycles)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice