TriangleNCT00123487 · OUTCOME
Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
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
- Day 1 up to 5 years
What was measured
MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Median duration was measured in months.
Analysis population: Participants who achieved a MaHR during the study.
Groups in this outcome
Dasatinib 140 mg QD
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
Dasatinib 70 mg BID
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
| Group | Source count |
|---|---|
| Dasatinib 140 mg QD | 156 |
| Dasatinib 70 mg BID | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 140 mg QD | 21.1 | Not reported | 14.4 | 30.7 | Not reported |
| Dasatinib 70 mg BID | 24.7 | Not reported | 19.5 | 35.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.4
- upper Limit
- 30.7
- value
- 21.1
- group Id
- OG001
- lower Limit
- 19.5
- upper Limit
- 35.6
- value
- 24.7
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Median duration was measured in months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
- id
- OG000
- title
- Dasatinib 140 mg QD
- description
- Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
- id
- OG001
- title
- Dasatinib 70 mg BID
- param Type
- MEDIAN
- population Description
- Participants who achieved a MaHR during the study.
- reporting Status
- POSTED
- time Frame
- Day 1 up to 5 years
- title
- Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice