TriangleNCT00123487 · OUTCOME
Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population
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
- Randomization up to 6 Months, 2 Years
What was measured
Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.
Analysis population: Participants were analyzed based on the treatment they were randomized to receive.
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 | 306 |
| Dasatinib 70 mg BID | 305 |
Reported measurements
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 140 mg QD | 36.9 | Not reported | 31.5 | 42.6 | Not reported |
| Dasatinib 70 mg BID | 39.3 | Not reported | 33.8 | 45.1 | Not reported |
2 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 140 mg QD | 41.5 | Not reported | 35.9 | 47.2 | Not reported |
| Dasatinib 70 mg BID | 41.3 | Not reported | 35.7 | 47.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.5
- upper Limit
- 42.6
- value
- 36.9
- group Id
- OG001
- lower Limit
- 33.8
- upper Limit
- 45.1
- value
- 39.3
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.9
- upper Limit
- 47.2
- value
- 41.5
- group Id
- OG001
- lower Limit
- 35.7
- upper Limit
- 47.1
- value
- 41.3
- title
- 2 Years
- denoms
- counts
- group Id
- OG000
- value
- 306
- group Id
- OG001
- value
- 305
- units
- Participants
- description
- Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.
- 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
- NUMBER
- population Description
- Participants were analyzed based on the treatment they were randomized to receive.
- reporting Status
- POSTED
- time Frame
- Randomization up to 6 Months, 2 Years
- title
- Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice