TriangleNCT02467270 · OUTCOME
Percentage of Participants With Treatment Emergent AEs Leading to Treatment Discontinuation, Dose Reduction and Dose Interruption
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
- Up to approximately 9.8 years
What was measured
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
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
TEAEs Leading to Treatment Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 24.5 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 19.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 20.2 | 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 | 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 |
TEAEs Leading to Dose Reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 51.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 39.4 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 34.0 | 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 | 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 |
TEAEs Leading to Dose Interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 80.9 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 68.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 66.0 | Not reported | Not reported | Not reported | Not reported |
| Close-out Period: Cohort A: Ponatinib 45 mg | 7.4 | 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 | 5.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24.5
- group Id
- OG001
- value
- 19.1
- group Id
- OG002
- value
- 20.2
- group Id
- OG003
- value
- 3.7
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- TEAEs Leading to Treatment Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 51.1
- group Id
- OG001
- value
- 39.4
- group Id
- OG002
- value
- 34.0
- group Id
- OG003
- value
- 3.7
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- TEAEs Leading to Dose Reduction
- categories
- measurements
- group Id
- OG000
- value
- 80.9
- group Id
- OG001
- value
- 68.1
- group Id
- OG002
- value
- 66.0
- group Id
- OG003
- value
- 7.4
- group Id
- OG004
- value
- 11.8
- group Id
- OG005
- value
- 5.9
- title
- TEAEs Leading to Dose Interruption
- 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
- An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
- 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
- Up to approximately 9.8 years
- title
- Percentage of Participants With Treatment Emergent AEs Leading to Treatment Discontinuation, Dose Reduction and Dose Interruption
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice