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NCT02467270 · OUTCOME

Percentage of Participants With Molecular Response 4 (MR4) and Molecular Response 4.5 (MR4.5)

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses · Source last updated 2026-03-17

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 approximately 9.5 years

What was measured

MR4 was defined as \<=0.01% BCR-ABL1IS. MR 4.5was defined as \<=0.0032% BCR-ALB1IS. MR4 and MR4.5 by each time point means the best outcome up to each time point after randomization.

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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment Period: Cohort A: Ponatinib 45 mg93
Treatment Period: Cohort B: Ponatinib 30 mg93
Treatment Period: Cohort C: Ponatinib 15 mg91

Reported measurements

MR4: 3 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg1.1Not reported0.05.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg1.1Not reported0.05.8Not reported
Treatment Period: Cohort C: Ponatinib 15 mg0Not reported0.04.0Not reported
MR4: 6 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg3.2Not reported0.79.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg2.2Not reported0.37.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg3.3Not reported0.79.3Not reported
MR4: 9 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg5.4Not reported1.812.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg8.6Not reported3.816.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg5.5Not reported1.812.4Not reported
MR4: 12 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg6.5Not reported2.413.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg9.7Not reported4.517.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg7.7Not reported3.115.2Not reported
MR4: 15 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg6.5Not reported2.413.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg9.7Not reported4.517.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg8.8Not reported3.916.6Not reported
MR4: 18 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg7.5Not reported3.114.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg9.7Not reported4.517.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg12.1Not reported6.220.6Not reported
MR4: 21 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg7.5Not reported3.114.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg12.1Not reported6.220.6Not reported
MR4: 24 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg10.8Not reported5.318.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort C: Ponatinib 15 mg12.1Not reported6.220.6Not reported
MR4: 27 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg13.2Not reported7.021.9Not reported
MR4: 30 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg13.2Not reported7.021.9Not reported
MR4: 33 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg16.1Not reported9.325.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg13.2Not reported7.021.9Not reported
MR4: 36 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg18.3Not reported11.027.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg14.3Not reported7.823.2Not reported
MR4: 39 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4: 42 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4: 45 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg16.1Not reported9.325.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 48 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg20.4Not reported12.830.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg16.1Not reported9.325.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 51 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg21.5Not reported13.731.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg17.2Not reported10.226.4Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 54 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg21.5Not reported13.731.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg17.2Not reported10.226.4Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 57 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg21.5Not reported13.731.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg18.3Not reported11.027.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 60 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg23.7Not reported15.533.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg18.3Not reported11.027.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 63 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg23.7Not reported15.533.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg18.3Not reported11.027.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 66 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg24.7Not reported16.434.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 69 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg24.7Not reported16.434.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 72 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg24.7Not reported16.434.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg18.7Not reported11.328.2Not reported
MR4: 75 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg24.7Not reported16.434.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 78 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 81 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 84 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 87 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 90 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 93 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 96 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 99 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 102 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 105 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 108 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 111 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4: 114 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg25.8Not reported17.335.9Not reported
Treatment Period: Cohort B: Ponatinib 30 mg19.4Not reported11.928.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reported12.229.4Not reported
MR4.5: 3 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg1.1Not reported0.05.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg0Not reported0.03.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg0Not reported0.04.0Not reported
MR4.5: 6 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg1.1Not reported0.05.8Not reported
Treatment Period: Cohort B: Ponatinib 30 mg1.1Not reported0.05.8Not reported
Treatment Period: Cohort C: Ponatinib 15 mg0Not reported0.04.0Not reported
MR4.5: 9 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg2.2Not reported0.37.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg3.2Not reported0.79.1Not reported
Treatment Period: Cohort C: Ponatinib 15 mg2.2Not reported0.37.7Not reported
MR4.5: 12 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg4.3Not reported1.210.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg6.5Not reported2.413.5Not reported
Treatment Period: Cohort C: Ponatinib 15 mg2.2Not reported0.37.7Not reported
MR4.5: 15 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg4.3Not reported1.210.6Not reported
Treatment Period: Cohort B: Ponatinib 30 mg7.5Not reported3.114.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg3.3Not reported0.79.3Not reported
MR4.5: 18 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg5.4Not reported1.812.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg7.5Not reported3.114.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg4.4Not reported1.210.9Not reported
MR4.5: 21 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg5.4Not reported1.812.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg7.5Not reported3.114.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg6.6Not reported2.513.8Not reported
MR4.5: 24 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg5.4Not reported1.812.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg8.6Not reported3.816.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg8.8Not reported3.916.6Not reported
MR4.5: 27 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg5.4Not reported1.812.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg8.6Not reported3.816.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg8.8Not reported3.916.6Not reported
MR4.5: 30 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg6.5Not reported2.413.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg8.6Not reported3.816.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg9.9Not reported4.617.9Not reported
MR4.5: 33 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg6.5Not reported2.413.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg8.6Not reported3.816.2Not reported
Treatment Period: Cohort C: Ponatinib 15 mg9.9Not reported4.617.9Not reported
MR4.5: 36 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg9.7Not reported4.517.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg11.0Not reported5.419.3Not reported
MR4.5: 39 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg9.7Not reported4.517.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg12.1Not reported6.220.6Not reported
MR4.5: 42 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg10.8Not reported5.318.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg13.2Not reported7.021.9Not reported
MR4.5: 45 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg10.8Not reported5.318.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 48 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg10.8Not reported5.318.9Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 51 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg11.8Not reported6.120.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 54 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 57 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 60 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 63 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 66 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg15.4Not reported8.724.5Not reported
MR4.5: 69 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg12.9Not reported6.821.5Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg16.5Not reported9.525.7Not reported
MR4.5: 72 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 75 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 78 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 81 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg14.0Not reported7.722.7Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 84 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 87 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 90 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 93 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 96 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 99 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 102 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 105 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 108 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 111 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
MR4.5: 114 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reported8.524.0Not reported
Treatment Period: Cohort C: Ponatinib 15 mg17.6Not reported10.427.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        5.8
        value
        1.1
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        5.8
        value
        1.1
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        4.0
        value
        0
    title
    MR4: 3 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        9.1
        value
        3.2
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        7.6
        value
        2.2
      3. group Id
        OG002
        lower Limit
        0.7
        upper Limit
        9.3
        value
        3.3
    title
    MR4: 6 Months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        12.1
        value
        5.4
      2. group Id
        OG001
        lower Limit
        3.8
        upper Limit
        16.2
        value
        8.6
      3. group Id
        OG002
        lower Limit
        1.8
        upper Limit
        12.4
        value
        5.5
    title
    MR4: 9 Months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        13.5
        value
        6.5
      2. group Id
        OG001
        lower Limit
        4.5
        upper Limit
        17.6
        value
        9.7
      3. group Id
        OG002
        lower Limit
        3.1
        upper Limit
        15.2
        value
        7.7
    title
    MR4: 12 Months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        13.5
        value
        6.5
      2. group Id
        OG001
        lower Limit
        4.5
        upper Limit
        17.6
        value
        9.7
      3. group Id
        OG002
        lower Limit
        3.9
        upper Limit
        16.6
        value
        8.8
    title
    MR4: 15 Months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        14.9
        value
        7.5
      2. group Id
        OG001
        lower Limit
        4.5
        upper Limit
        17.6
        value
        9.7
      3. group Id
        OG002
        lower Limit
        6.2
        upper Limit
        20.6
        value
        12.1
    title
    MR4: 18 Months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        14.9
        value
        7.5
      2. group Id
        OG001
        lower Limit
        6.1
        upper Limit
        20.2
        value
        11.8
      3. group Id
        OG002
        lower Limit
        6.2
        upper Limit
        20.6
        value
        12.1
    title
    MR4: 21 Months
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        18.9
        value
        10.8
      2. group Id
        OG001
        lower Limit
        6.8
        upper Limit
        21.5
        value
        12.9
      3. group Id
        OG002
        lower Limit
        6.2
        upper Limit
        20.6
        value
        12.1
    title
    MR4: 24 Months
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        20.2
        value
        11.8
      2. group Id
        OG001
        lower Limit
        8.5
        upper Limit
        24.0
        value
        15.1
      3. group Id
        OG002
        lower Limit
        7.0
        upper Limit
        21.9
        value
        13.2
    title
    MR4: 27 Months
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        21.5
        value
        12.9
      2. group Id
        OG001
        lower Limit
        8.5
        upper Limit
        24.0
        value
        15.1
      3. group Id
        OG002
        lower Limit
        7.0
        upper Limit
        21.9
        value
        13.2
    title
    MR4: 30 Months
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.3
        upper Limit
        25.2
        value
        16.1
      2. group Id
        OG001
        lower Limit
        8.5
        upper Limit
        24.0
        value
        15.1
      3. group Id
        OG002
        lower Limit
        7.0
        upper Limit
        21.9
        value
        13.2
    title
    MR4: 33 Months
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.0
        upper Limit
        27.6
        value
        18.3
      2. group Id
        OG001
        lower Limit
        8.5
        upper Limit
        24.0
        value
        15.1
      3. group Id
        OG002
        lower Limit
        7.8
        upper Limit
        23.2
        value
        14.3
    title
    MR4: 36 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      93
    3. group Id
      OG002
      value
      91
    units
    Participants
description
MR4 was defined as \<=0.01% BCR-ABL1IS. MR 4.5was defined as \<=0.0032% BCR-ALB1IS. MR4 and MR4.5 by each time point means the best outcome up to each time point after randomization.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
NUMBER
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.
reporting Status
POSTED
time Frame
Up to approximately 9.5 years
title
Percentage of Participants With Molecular Response 4 (MR4) and Molecular Response 4.5 (MR4.5)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice