TriangleNCT01207440 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 48 months after first dose
What was measured
Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.
Analysis population: Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Number analyzed is number of participants with data available for analysis at given time-point
Groups in this outcome
Cohort A: CP-CML R-I
CP-CML participants 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 B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (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 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 A: CP-CML R-I | 203 |
| Cohort B: CP-CML With T315I Mutation | 64 |
| 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
Hematologic Response
| Group | Source count |
|---|---|
| Cohort A: CP-CML R-I | 192 |
| Cohort B: CP-CML With T315I Mutation | 59 |
| Cohort C: AP-CML R-I | 37 |
| Cohort D: AP-CML With T315I Mutation | 10 |
| Cohort E: BP-CML/Ph+ ALL R-I | 17 |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | NA | Not reported | 36 | 2172 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort B: CP-CML With T315I Mutation | NA | Not reported | 33 | 2171 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort C: AP-CML R-I | 360.0 | Not reported | 35 | 2079 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 732.0 | Not reported | 42 | 1334 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 196.0 | Not reported | 54 | 1811 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 108.0 | Not reported | 54 | 1038 | Not reported |
Cytogenetic Response
| Group | Source count |
|---|---|
| Cohort A: CP-CML R-I | 103 |
| Cohort B: CP-CML With T315I Mutation | 45 |
| Cohort C: AP-CML R-I | 22 |
| Cohort D: AP-CML With T315I Mutation | 10 |
| Cohort E: BP-CML/Ph+ ALL R-I | 13 |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | NA | Not reported | 1 | 1963 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort B: CP-CML With T315I Mutation | NA | Not reported | 1 | 1903 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort C: AP-CML R-I | NA | Not reported | 1 | 1779 | Duration of response was not reached due to fewer number of participants with events. |
| Cohort D: AP-CML With T315I Mutation | 728.0 | Not reported | 28 | 1569 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | NA | Not reported | 1 | 1770 | Duration of response was not reached due to fewer number of participants with events. |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 63.0 | Not reported | 1 | 673 | Not reported |
Molecular Response
| Group | Source count |
|---|---|
| Cohort A: CP-CML R-I | 71 |
| Cohort B: CP-CML With T315I Mutation | 37 |
| Cohort C: AP-CML R-I | 12 |
| Cohort D: AP-CML With T315I Mutation | 6 |
| Cohort E: BP-CML/Ph+ ALL R-I | 9 |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | NA | Not reported | 78 | 1891 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort B: CP-CML With T315I Mutation | NA | Not reported | 1 | 1899 | Duration of response was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort C: AP-CML R-I | 560.0 | Not reported | 1 | 1666 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 222.0 | Not reported | 1 | 783 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | NA | Not reported | 1 | 1742 | Duration of response was not reached due to fewer number of participants with events. |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 98.0 | Not reported | 1 | 98 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG000
- lower Limit
- 36
- upper Limit
- 2172
- value
- NA
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG001
- lower Limit
- 33
- upper Limit
- 2171
- value
- NA
- group Id
- OG002
- lower Limit
- 35
- upper Limit
- 2079
- value
- 360.0
- group Id
- OG003
- lower Limit
- 42
- upper Limit
- 1334
- value
- 732.0
- group Id
- OG004
- lower Limit
- 54
- upper Limit
- 1811
- value
- 196.0
- group Id
- OG005
- lower Limit
- 54
- upper Limit
- 1038
- value
- 108.0
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 37
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 15
- units
- Participants
- title
- Hematologic Response
- categories
- measurements
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 1963
- value
- NA
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 1903
- value
- NA
- comment
- Duration of response was not reached due to fewer number of participants with events.
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 1779
- value
- NA
- group Id
- OG003
- lower Limit
- 28
- upper Limit
- 1569
- value
- 728.0
- comment
- Duration of response was not reached due to fewer number of participants with events.
- group Id
- OG004
- lower Limit
- 1
- upper Limit
- 1770
- value
- NA
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 673
- value
- 63.0
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 16
- units
- Participants
- title
- Cytogenetic Response
- categories
- measurements
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG000
- lower Limit
- 78
- upper Limit
- 1891
- value
- NA
- comment
- Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 1899
- value
- NA
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 1666
- value
- 560.0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 783
- value
- 222.0
- comment
- Duration of response was not reached due to fewer number of participants with events.
- group Id
- OG004
- lower Limit
- 1
- upper Limit
- 1742
- value
- NA
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 98
- value
- 98.0
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Molecular Response
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 65
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 48
- group Id
- OG005
- value
- 46
- units
- Participants
- description
- Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.
- dispersion Type
- Full Range
- groups
- description
- CP-CML participants 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 A: CP-CML R-I
- description
- CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (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 B: CP-CML With T315I Mutation
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- title
- Cohort F: BP-CML or Ph+ ALL With T315I Mutation
- param Type
- MEDIAN
- population Description
- Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Number analyzed is number of participants with data available for analysis at given time-point
- reporting Status
- POSTED
- time Frame
- Up to approximately 48 months after first dose
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice