TriangleNCT00123474 · OUTCOME
Percent of Participants With MCyR At or Prior to 24 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
- 24 months
What was measured
CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: 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. 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
Dasatinib QD
Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Dasatinib BID
Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 100 mg Total Daily Dose
Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Dasatinib 140 mg Total Daily Dose
Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
| Group | Source count |
|---|---|
| Dasatinib QD | 247 |
| Dasatinib BID | 250 |
| Dasatinib 100 mg Total Daily Dose | 248 |
| Dasatinib 140 mg Total Daily Dose | 249 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib QD | 58.3 | Not reported | 51.9 | 64.5 | Not reported |
| Dasatinib BID | 56.4 | Not reported | 50.0 | 62.6 | Not reported |
| Dasatinib 100 mg Total Daily Dose | 57.3 | Not reported | 50.8 | 63.5 | Not reported |
| Dasatinib 140 mg Total Daily Dose | 57.4 | Not reported | 51.0 | 63.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- -6.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.6
- 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
- 1.9
- tested Non Inferiority
- true
- ci Lower Limit
- -8.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.5
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- -0.2
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Lower Limit
- -6.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.6
- 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
- 1.9
- tested Non Inferiority
- true
- ci Lower Limit
- -8.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.5
- group Ids
- OG002
- OG003
- non Inferiority Comment
- Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Risk Difference (RD)
- param Value
- -0.2
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.9
- upper Limit
- 64.5
- value
- 58.3
- group Id
- OG001
- lower Limit
- 50.0
- upper Limit
- 62.6
- value
- 56.4
- group Id
- OG002
- lower Limit
- 50.8
- upper Limit
- 63.5
- value
- 57.3
- group Id
- OG003
- lower Limit
- 51.0
- upper Limit
- 63.7
- value
- 57.4
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 250
- group Id
- OG002
- value
- 248
- group Id
- OG003
- value
- 249
- units
- Participants
- description
- CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: 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. 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 QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG000
- title
- Dasatinib QD
- description
- Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG001
- title
- Dasatinib BID
- description
- Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG002
- title
- Dasatinib 100 mg Total Daily Dose
- description
- Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG003
- title
- Dasatinib 140 mg Total Daily Dose
- param Type
- NUMBER
- population Description
- All randomized imatinib-resistant participants with available data were summarized.
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of Participants
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Preserved source evidence · Not medical advice