NCT01207440 · OUTCOME

Overall Survival (OS)

Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) · Source last updated 2021-02-02

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: From the first dose of study treatment until death (Up to 96 months post last dose)

What was measured

OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.

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

Analysis denominator · Participants

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

Values in days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort A: CP-CML R-I	NA	Not reported	NA	NA	Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
Cohort B: CP-CML With T315I Mutation	NA	Not reported	NA	NA	Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
Cohort C: AP-CML R-I	1689.0	Not reported	969.0	NA	Upper limit of 95% confidence interval was not estimable due to fewer number of participants with events.
Cohort D: AP-CML With T315I Mutation	1847.0	Not reported	281.0	2143.0	Not reported
Cohort E: BP-CML/Ph+ ALL R-I	209.0	Not reported	119.0	379.0	Not reported
Cohort F: BP-CML or Ph+ ALL With T315I Mutation	200.0	Not reported	150.0	279.0	Not reported

Complete source fields

classes

categories
measurements
comment
Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Upper limit of 95% confidence interval was not estimable due to fewer number of participants with events.
group Id
OG002
lower Limit
969.0
upper Limit
NA
value
1689.0
group Id
OG003
lower Limit
281.0
upper Limit
2143.0
value
1847.0
group Id
OG004
lower Limit
119.0
upper Limit
379.0
value
209.0
group Id
OG005
lower Limit
150.0
upper Limit
279.0
value
200.0

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

OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.

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

From the first dose of study treatment until death (Up to 96 months post last dose)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

days

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Preserved source evidence · Not medical advice