TriangleNCT02467270 · OUTCOME
Percentage of Participants With Molecular Response 1 (MR1)
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
- 3 months after the first dose of study treatment
What was measured
MR1 was defined as percentage of participants achieving a ratio of \<=10% Breakpoint Cluster Region-Abelson (BCR-ABL1) transcripts on the international scale. MR1 is molecular response with 1-log reduction in transcript.
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 | Source count |
|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 93 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 93 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 52.7 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 44.1 | Not reported | Not reported | Not reported | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 42.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 52.7
- group Id
- OG001
- value
- 44.1
- group Id
- OG002
- value
- 42.9
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- MR1 was defined as percentage of participants achieving a ratio of \<=10% Breakpoint Cluster Region-Abelson (BCR-ABL1) transcripts on the international scale. MR1 is molecular response with 1-log reduction in transcript.
- 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
- 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
- 3 months after the first dose of study treatment
- title
- Percentage of Participants With Molecular Response 1 (MR1)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice