TriangleNCT01207440 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)
What was measured
PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to \>20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.
Analysis population: Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | NA | Not reported | 1285.0 | NA | PFS was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort B: CP-CML With T315I Mutation | 1809.0 | Not reported | 1028.0 | NA | PFS was not reached for Cohorts A and B due to fewer number of participants with events. |
| Cohort C: AP-CML R-I | 432.0 | Not reported | 335.0 | 714.0 | Not reported |
| Cohort D: AP-CML With T315I Mutation | 959.0 | Not reported | 186.0 | 1847.0 | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 111.0 | Not reported | 55.0 | 169.0 | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 83.0 | Not reported | 55.0 | 150.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- PFS was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG000
- lower Limit
- 1285.0
- upper Limit
- NA
- value
- NA
- comment
- PFS was not reached for Cohorts A and B due to fewer number of participants with events.
- group Id
- OG001
- lower Limit
- 1028.0
- upper Limit
- NA
- value
- 1809.0
- group Id
- OG002
- lower Limit
- 335.0
- upper Limit
- 714.0
- value
- 432.0
- group Id
- OG003
- lower Limit
- 186.0
- upper Limit
- 1847.0
- value
- 959.0
- group Id
- OG004
- lower Limit
- 55.0
- upper Limit
- 169.0
- value
- 111.0
- group Id
- OG005
- lower Limit
- 55.0
- upper Limit
- 150.0
- value
- 83.0
- 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
- PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to \>20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.
- dispersion Type
- 95% Confidence Interval
- 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.
- reporting Status
- POSTED
- time Frame
- Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice