TriangleNCT00123474 · OUTCOME
Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose
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, 24 months
What was measured
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; 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 CCyR or PCyR.
Analysis population: All randomized imatinib-intolerant participants with available data were summarized.
Groups in this outcome
QD Dasatinib
Participants received either 100 mg or 140 mg once a day (QD) 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) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Total Daily Dose 100 mg
Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Total Daily Dose 140 mg
Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
| Group | Source count |
|---|---|
| QD Dasatinib | 87 |
| BID Dasatinib | 85 |
| Total Daily Dose 100 mg | 87 |
| Total Daily Dose 140 mg | 86 |
Reported measurements
6 Month
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| QD Dasatinib | 72.4 | Not reported | 61.8 | 81.5 | Not reported |
| BID Dasatinib | 70.6 | Not reported | 59.7 | 80.0 | Not reported |
| Total Daily Dose 100 mg | 73.6 | Not reported | 63.0 | 82.4 | Not reported |
| Total Daily Dose 140 mg | 69.4 | Not reported | 58.5 | 79.0 | Not reported |
24 Month
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| QD Dasatinib | 77.0 | Not reported | 66.8 | 85.4 | Not reported |
| BID Dasatinib | 75.6 | Not reported | 65.1 | 84.2 | Not reported |
| Total Daily Dose 100 mg | 77.0 | Not reported | 66.8 | 85.4 | Not reported |
| Total Daily Dose 140 mg | 75.6 | Not reported | 65.1 | 84.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- -11.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.3
- 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% 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
- 1.8
- tested Non Inferiority
- true
- ci Lower Limit
- -9.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.6
- group Description
- 6 Month Analysis
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 4.2
- tested Non Inferiority
- true
- ci Lower Limit
- -11.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.1
- group Description
- 24 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% 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
- 1.4
- tested Non Inferiority
- true
- ci Lower Limit
- -11.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.1
- group Description
- 24 Month Analysis
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 1.4
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Lower Limit
- -11.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.3
- 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% 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
- 1.8
- tested Non Inferiority
- true
- ci Lower Limit
- -9.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.6
- group Description
- 6 Month Analysis
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 4.2
- tested Non Inferiority
- true
- ci Lower Limit
- -11.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.1
- group Description
- 24 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% 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
- 1.4
- tested Non Inferiority
- true
- ci Lower Limit
- -11.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.1
- group Description
- 24 Month Analysis
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- 1.4
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.8
- upper Limit
- 81.5
- value
- 72.4
- group Id
- OG001
- lower Limit
- 59.7
- upper Limit
- 80.0
- value
- 70.6
- group Id
- OG002
- lower Limit
- 63.0
- upper Limit
- 82.4
- value
- 73.6
- group Id
- OG003
- lower Limit
- 58.5
- upper Limit
- 79.0
- value
- 69.4
- title
- 6 Month
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.8
- upper Limit
- 85.4
- value
- 77.0
- group Id
- OG001
- lower Limit
- 65.1
- upper Limit
- 84.2
- value
- 75.6
- group Id
- OG002
- lower Limit
- 66.8
- upper Limit
- 85.4
- value
- 77.0
- group Id
- OG003
- lower Limit
- 65.1
- upper Limit
- 84.2
- value
- 75.6
- title
- 24 Month
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 87
- group Id
- OG003
- value
- 86
- units
- Participants
- description
- 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; 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 CCyR or PCyR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received either 100 mg or 140 mg once a day (QD) 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) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG001
- title
- BID Dasatinib
- description
- Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG002
- title
- Total Daily Dose 100 mg
- description
- Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG003
- title
- Total Daily Dose 140 mg
- param Type
- NUMBER
- population Description
- All randomized imatinib-intolerant participants with available data were summarized.
- reporting Status
- POSTED
- time Frame
- 6 months, 24 months
- title
- Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice