TriangleNCT03011372 · OUTCOME
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 2513 days (120 21-day treatment cycles)
What was measured
CR=all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent/equal to "mild reticulin fibrosis"; (3) WBC ≤10 x 10\^9 cells/L; Hgb ≥11 g/dL; platelets ≥100 x 10\^9/L, ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts=0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present pre-therapy, including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted. PR=all of the following improvements: (1) reduction of bone marrow blasts/blast equivalents by 50%, but remaining \>5% of cellularity (except in cases with ≤5% bone marrow blasts at baseline); (2) normalization of peripheral blood indices per CR Criterion 3; (3) extra medullary disease response of CMR/CR or PMR/PR.
Analysis population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. CMR=complete metabolic response; PMR=partial metabolic response. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemigatinib 13.5 mg | 77.8 | Not reported | 62.91 | 88.80 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.91
- upper Limit
- 88.80
- value
- 77.8
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- description
- CR=all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent/equal to "mild reticulin fibrosis"; (3) WBC ≤10 x 10\^9 cells/L; Hgb ≥11 g/dL; platelets ≥100 x 10\^9/L, ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts=0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present pre-therapy, including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted. PR=all of the following improvements: (1) reduction of bone marrow blasts/blast equivalents by 50%, but remaining \>5% of cellularity (except in cases with ≤5% bone marrow blasts at baseline); (2) normalization of peripheral blood indices per CR Criterion 3; (3) extra medullary disease response of CMR/CR or PMR/PR.
- 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
- NUMBER
- population Description
- Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. CMR=complete metabolic response; PMR=partial metabolic response. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).
- reporting Status
- POSTED
- time Frame
- up to 2513 days (120 21-day treatment cycles)
- title
- Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice