TriangleNCT02467270 · OUTCOME
Percentage of Participants With Adjusted Incidence Rates for Treatment Emergent Arterial Occlusive Events (AOEs), Venous Thrombotic Events (VTEs), Adverse Events (AEs), and Serious AEs (SAEs)
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
- Not reported
- Time frame
- From first dose up to 30 days after last dose of the study drug (up to approximately 9.8 years)
What was measured
Percentage of participants with adjusted incidence rates who developed AOEs and VTEs were categorized according to arterial occlusive events and venous thrombotic events. AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with treatment. 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 congenital anomaly/birth defect/is medically important event that may not be immediately life-threatening/result in death or hospitalization, but may jeopardize participant/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.
Analysis population: Safety Population included all participants who received at least 1 dose of 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.
Close-out 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.
Close-out Period: Cohort B: Ponatinib 30 mg
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.
Close-out 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 | 94 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 94 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 94 |
| Close-out Period: Cohort A: Ponatinib 45 mg | 27 |
| Close-out Period: Cohort B: Ponatinib 30 mg | 17 |
| Close-out Period: Cohort C: Ponatinib 15 mg | 17 |
Reported measurements
AOEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 13.8 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 9.6 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 5.3 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort A: Ponatinib 45 mg | 3.7 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort B: Ponatinib 30 mg | 11.8 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort C: Ponatinib 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
VTEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 1.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 1.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 1.1 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort A: Ponatinib 45 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort B: Ponatinib 30 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort C: Ponatinib 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 97.9 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 97.9 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort A: Ponatinib 45 mg | 74.1 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort B: Ponatinib 30 mg | 94.1 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort C: Ponatinib 15 mg | 76.5 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 40.4 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 35.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 41.5 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort A: Ponatinib 45 mg | 3.7 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort B: Ponatinib 30 mg | 17.6 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort C: Ponatinib 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13.8
- group Id
- OG001
- value
- 9.6
- group Id
- OG002
- value
- 5.3
- group Id
- OG003
- value
- 3.7
- group Id
- OG004
- value
- 11.8
- group Id
- OG005
- value
- 0
- title
- AOEs
- categories
- measurements
- group Id
- OG000
- value
- 1.1
- group Id
- OG001
- value
- 1.1
- group Id
- OG002
- value
- 1.1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- VTEs
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 97.9
- group Id
- OG002
- value
- 97.9
- group Id
- OG003
- value
- 74.1
- group Id
- OG004
- value
- 94.1
- group Id
- OG005
- value
- 76.5
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 40.4
- group Id
- OG001
- value
- 35.1
- group Id
- OG002
- value
- 41.5
- group Id
- OG003
- value
- 3.7
- group Id
- OG004
- value
- 17.6
- group Id
- OG005
- value
- 0
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 94
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 17
- units
- Participants
- description
- Percentage of participants with adjusted incidence rates who developed AOEs and VTEs were categorized according to arterial occlusive events and venous thrombotic events. AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with treatment. 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 congenital anomaly/birth defect/is medically important event that may not be immediately life-threatening/result in death or hospitalization, but may jeopardize participant/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.
- 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
- 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
- OG003
- title
- Close-out Period: Cohort A: Ponatinib 45 mg
- description
- 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
- OG004
- title
- Close-out Period: Cohort B: Ponatinib 30 mg
- description
- Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
- id
- OG005
- title
- Close-out Period: Cohort C: Ponatinib 15 mg
- param Type
- NUMBER
- population Description
- Safety Population included all participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after last dose of the study drug (up to approximately 9.8 years)
- title
- Percentage of Participants With Adjusted Incidence Rates for Treatment Emergent Arterial Occlusive Events (AOEs), Venous Thrombotic Events (VTEs), Adverse Events (AEs), and Serious AEs (SAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice