TriangleNCT01207440 · OUTCOME
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR
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
- Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
What was measured
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Analysis population: Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.
Groups in this outcome
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
| Group | Source count |
|---|---|
| Cohort C: AP-CML R-I | 65 |
| Cohort D: AP-CML With T315I Mutation | 18 |
| Cohort E: BP-CML/Ph+ ALL R-I | 48 |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort C: AP-CML R-I | 18.5 | Not reported | 9.9 | 30.0 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 33.3 | Not reported | 13.3 | 59.0 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 18.8 | Not reported | 8.9 | 32.6 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 4.3 | Not reported | 0.5 | 14.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.9
- upper Limit
- 30.0
- value
- 18.5
- group Id
- OG001
- lower Limit
- 13.3
- upper Limit
- 59.0
- value
- 33.3
- group Id
- OG002
- lower Limit
- 8.9
- upper Limit
- 32.6
- value
- 18.8
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 14.8
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 46
- units
- Participants
- description
- MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
- id
- OG000
- title
- Cohort C: AP-CML R-I
- description
- AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
- id
- OG001
- title
- Cohort D: AP-CML With T315I Mutation
- description
- BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
- id
- OG002
- title
- Cohort E: BP-CML/Ph+ ALL R-I
- description
- BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
- id
- OG003
- title
- Cohort F: BP-CML or Ph+ ALL With T315I Mutation
- param Type
- NUMBER
- population Description
- Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.
- reporting Status
- POSTED
- time Frame
- Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
- title
- Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice