TriangleNCT00306202 · OUTCOME
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
What was measured
A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR). Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs.
Analysis population: All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m\^2.
Groups in this outcome
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 9 |
Reported measurements
CHR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 55.6 | Not reported | 21.2 | 86.3 | Not reported |
MaHR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 66.7 | Not reported | 29.9 | 92.5 | Not reported |
OHR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 66.7 | Not reported | 29.9 | 92.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.2
- upper Limit
- 86.3
- value
- 55.6
- title
- CHR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.9
- upper Limit
- 92.5
- value
- 66.7
- title
- MaHR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.9
- upper Limit
- 92.5
- value
- 66.7
- title
- OHR
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR). Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs.
- dispersion Type
- 95% Confidence Interval
- groups
- 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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
- param Type
- NUMBER
- population Description
- All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m\^2.
- reporting Status
- POSTED
- time Frame
- Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
- title
- Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice