TriangleNCT02719574 · OUTCOME
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
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
- Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
What was measured
Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
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 only for cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with overall response 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) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | NA | Not reported | NA | NA | Median and 95% CI could not be calculated since there is only one participant for Cohort 4. |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 11.90 | Not reported | 2.80 | NA | Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median for Cohort 5. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI could not be calculated since there is only one participant for Cohort 4.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median for Cohort 5.
- group Id
- OG001
- lower Limit
- 2.80
- upper Limit
- NA
- value
- 11.90
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
- 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
- MEDIAN
- 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 only for cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with overall response for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
- title
- Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice