TriangleNCT00123474 · OUTCOME
Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
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
- 6 months
What was measured
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
Analysis population: All randomized imatinib-resistant participants with available data were summarized.
Groups in this outcome
QD Dasatinib
Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
BID Dasatinib
Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
| Group | Source count |
|---|---|
| QD Dasatinib | 247 |
| BID Dasatinib | 251 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| QD Dasatinib | 51.8 | Not reported | 45.4 | 58.2 | Not reported |
| BID Dasatinib | 49.0 | Not reported | 42.7 | 55.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- -6.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.6
- group Description
- 6 Month Analysis
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 2.8
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Lower Limit
- -6.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.6
- group Description
- 6 Month Analysis
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 2.8
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.4
- upper Limit
- 58.2
- value
- 51.8
- group Id
- OG001
- lower Limit
- 42.7
- upper Limit
- 55.4
- value
- 49.0
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 251
- units
- Participants
- description
- Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG000
- title
- QD Dasatinib
- description
- Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG001
- title
- BID Dasatinib
- param Type
- NUMBER
- population Description
- All randomized imatinib-resistant participants with available data were summarized.
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
- type
- PRIMARY
- unit Of Measure
- percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice