TriangleNCT02467270 · OUTCOME
Duration of Major Molecular Response (MMR/MR3)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to approximately 8.9 years
What was measured
Duration of MMR/MR3 was defined as the interval between the first assessment at which the criteria for \<=0.1% MMR were met until the earliest date at which loss of \<=0.1% MMR occurred, or the criteria for progression were met. Progression to accelerated phase (AP) was defined as: \>= 15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter (/L) in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to blast phase (BP) was defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Analysis population: ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR3.
Groups in this outcome
Treatment Period: Cohort A: Ponatinib 45 mg
Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Treatment Period: Cohort B: Ponatinib 30 mg
Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Treatment Period: Cohort C: Ponatinib 15 mg
Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
| Group | Source count |
|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 45 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 28 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | NA | Not reported | NA | NA | Median and 95% confidence interval (CI) were not available due to censoring. |
| Treatment Period: Cohort B: Ponatinib 30 mg | NA | Not reported | 27.3 | NA | Median and upper limit of 95% CI were not available due to censoring. |
| Treatment Period: Cohort C: Ponatinib 15 mg | NA | Not reported | NA | NA | Median and 95% CI were not available due to censoring. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% confidence interval (CI) were not available due to censoring.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit of 95% CI were not available due to censoring.
- group Id
- OG001
- lower Limit
- 27.3
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI were not available due to censoring.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 24
- units
- Participants
- description
- Duration of MMR/MR3 was defined as the interval between the first assessment at which the criteria for \<=0.1% MMR were met until the earliest date at which loss of \<=0.1% MMR occurred, or the criteria for progression were met. Progression to accelerated phase (AP) was defined as: \>= 15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter (/L) in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to blast phase (BP) was defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
- id
- OG000
- title
- Treatment Period: Cohort A: Ponatinib 45 mg
- description
- Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
- id
- OG001
- title
- Treatment Period: Cohort B: Ponatinib 30 mg
- description
- Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
- id
- OG002
- title
- Treatment Period: Cohort C: Ponatinib 15 mg
- param Type
- MEDIAN
- population Description
- ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR3.
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately 8.9 years
- title
- Duration of Major Molecular Response (MMR/MR3)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice