TriangleNCT01207440 · OUTCOME
Time to 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
Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.
Analysis population: Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Median time to response was reported for responders only. Participants who did not achieve the specified response were censored at the last response assessment. Number analyzed: participants with data available 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 | 13.0 | Not reported | 1 | 417 | Not reported |
| Cohort B: CP-CML With T315I Mutation | 10.0 | Not reported | 4 | 1008 | Not reported |
| Cohort C: AP-CML R-I | 21.0 | Not reported | 12 | 112 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 20.5 | Not reported | 14 | 176 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 28.0 | Not reported | 14 | 168 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 24.0 | Not reported | 11 | 57 | 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 | 85.0 | Not reported | 56 | 343 | Not reported |
| Cohort B: CP-CML With T315I Mutation | 84.0 | Not reported | 49 | 333 | Not reported |
| Cohort C: AP-CML R-I | 113.5 | Not reported | 26 | 280 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 83.0 | Not reported | 25 | 295 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 28.0 | Not reported | 28 | 168 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 56.0 | Not reported | 27 | 112 | 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 | 173.0 | Not reported | 55 | 1686 | Not reported |
| Cohort B: CP-CML With T315I Mutation | 167.0 | Not reported | 81 | 756 | Not reported |
| Cohort C: AP-CML R-I | 340.5 | Not reported | 55 | 1364 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 335.5 | Not reported | 107 | 925 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 56.0 | Not reported | 54 | 113 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 63.0 | Not reported | 59 | 67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 417
- value
- 13.0
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 1008
- value
- 10.0
- group Id
- OG002
- lower Limit
- 12
- upper Limit
- 112
- value
- 21.0
- group Id
- OG003
- lower Limit
- 14
- upper Limit
- 176
- value
- 20.5
- group Id
- OG004
- lower Limit
- 14
- upper Limit
- 168
- value
- 28.0
- group Id
- OG005
- lower Limit
- 11
- upper Limit
- 57
- value
- 24.0
- 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
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 343
- value
- 85.0
- group Id
- OG001
- lower Limit
- 49
- upper Limit
- 333
- value
- 84.0
- group Id
- OG002
- lower Limit
- 26
- upper Limit
- 280
- value
- 113.5
- group Id
- OG003
- lower Limit
- 25
- upper Limit
- 295
- value
- 83.0
- group Id
- OG004
- lower Limit
- 28
- upper Limit
- 168
- value
- 28.0
- group Id
- OG005
- lower Limit
- 27
- upper Limit
- 112
- value
- 56.0
- 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
- group Id
- OG000
- lower Limit
- 55
- upper Limit
- 1686
- value
- 173.0
- group Id
- OG001
- lower Limit
- 81
- upper Limit
- 756
- value
- 167.0
- group Id
- OG002
- lower Limit
- 55
- upper Limit
- 1364
- value
- 340.5
- group Id
- OG003
- lower Limit
- 107
- upper Limit
- 925
- value
- 335.5
- group Id
- OG004
- lower Limit
- 54
- upper Limit
- 113
- value
- 56.0
- group Id
- OG005
- lower Limit
- 59
- upper Limit
- 67
- value
- 63.0
- 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
- Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.
- 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. Median time to response was reported for responders only. Participants who did not achieve the specified response were censored at the last response assessment. Number analyzed: participants with data available at given time-point.
- reporting Status
- POSTED
- time Frame
- Up to approximately 48 months after first dose
- title
- Time to Response
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice