TriangleNCT01207440 · OUTCOME
Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)
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
- Up to 12 months after initiation of study treatment
What was measured
MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
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 A and B only.
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).
| Group | Source count |
|---|---|
| Cohort A: CP-CML R-I | 203 |
| Cohort B: CP-CML With T315I Mutation | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | 50.7 | Not reported | 43.6 | 57.8 | Not reported |
| Cohort B: CP-CML With T315I Mutation | 70.3 | Not reported | 57.6 | 81.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.6
- upper Limit
- 57.8
- value
- 50.7
- group Id
- OG001
- lower Limit
- 57.6
- upper Limit
- 81.1
- value
- 70.3
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 64
- units
- Participants
- description
- MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
- 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
- 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 A and B only.
- reporting Status
- POSTED
- time Frame
- Up to 12 months after initiation of study treatment
- title
- Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice