TriangleNCT00306202 · OUTCOME
Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).
What was measured
Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval. Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3. Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method.
Analysis population: All treated participants with CHR in strata 1 and 2/3.
Groups in this outcome
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 16 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 21.5 | Not reported | 16.0 | 23.0 | Not reported |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 39.5 | Not reported | 36.0 | 44.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.0
- upper Limit
- 23.0
- value
- 21.5
- group Id
- OG001
- lower Limit
- 36.0
- upper Limit
- 44.0
- value
- 39.5
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval. Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3. Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
- param Type
- MEDIAN
- population Description
- All treated participants with CHR in strata 1 and 2/3.
- reporting Status
- POSTED
- time Frame
- Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).
- title
- Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice