TriangleNCT02467270 · OUTCOME
Time to Response (MR2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to approximately 5 years
What was measured
Time to response was defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. Response was defined as any participants who achieved ≤1% BCR-ABL1IS (MR2) at any time during the study. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (\<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the Baseline sum diameters.
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. Overall number of participants analyzed is the number of participants with MR2.
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 | 56 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 38 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 6.00 | Not reported | 5.8 | 6.1 | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 3.11 | Not reported | 3.0 | 6.0 | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 6.18 | Not reported | 3.1 | 14.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 6.1
- value
- 6.00
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 6.0
- value
- 3.11
- group Id
- OG002
- lower Limit
- 3.1
- upper Limit
- 14.5
- value
- 6.18
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 36
- units
- Participants
- description
- Time to response was defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. Response was defined as any participants who achieved ≤1% BCR-ABL1IS (MR2) at any time during the study. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (\<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the Baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- 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. Overall number of participants analyzed is the number of participants with MR2.
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately 5 years
- title
- Time to Response (MR2)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice