TriangleNCT01207440 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)
What was measured
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
Analysis population: The safety population included all participants 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).
Unassigned to Cohorts A-F
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, 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 |
| Unassigned to Cohorts A-F | 5 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | 203 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: CP-CML With T315I Mutation | 64 | Not reported | Not reported | Not reported | Not reported |
| Cohort C: AP-CML R-I | 65 | Not reported | Not reported | Not reported | Not reported |
| Cohort D: AP-CML With T315I Mutation | 18 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 48 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 46 | Not reported | Not reported | Not reported | Not reported |
| Unassigned to Cohorts A-F | 5 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: CP-CML R-I | 132 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: CP-CML With T315I Mutation | 39 | Not reported | Not reported | Not reported | Not reported |
| Cohort C: AP-CML R-I | 44 | Not reported | Not reported | Not reported | Not reported |
| Cohort D: AP-CML With T315I Mutation | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort E: BP-CML/Ph+ ALL R-I | 41 | Not reported | Not reported | Not reported | Not reported |
| Cohort F: BP-CML or Ph+ ALL With T315I Mutation | 37 | Not reported | Not reported | Not reported | Not reported |
| Unassigned to Cohorts A-F | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- group Id
- OG006
- value
- 5
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 41
- group Id
- OG005
- value
- 37
- group Id
- OG006
- value
- 3
- title
- SAE
- 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
- group Id
- OG006
- value
- 5
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
- 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
- description
- Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, 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
- OG006
- title
- Unassigned to Cohorts A-F
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all participants who received at least 1 dose of ponatinib.
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)
- title
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice