TriangleNCT02719574 · OUTCOME
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
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
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
What was measured
Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.
Analysis population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Groups in this outcome
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
| Group | Source count |
|---|---|
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 1 |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 0 | Not reported | 0.0 | 97.5 | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 13 | Not reported | 0.3 | 52.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 97.5
- value
- 0
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 52.7
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG000
- title
- Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG001
- title
- Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
- param Type
- NUMBER
- population Description
- FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
- title
- Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice