TriangleNCT02094573 · OUTCOME
Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
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
- 95% Confidence Interval
- Time frame
- Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered Cycle of 28-days) through 15 Cycles and every 3 Cycles thereafter until disease progression or up to end of the study (approximately up to 69 months)
What was measured
ORR assessed by the IRC, was defined as the percentage of the participants with CR or PR according to RECIST v1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. 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 norrmalization of tumor marker level. PR: at least a 30% decrease in theSLD of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 95% confidence interval was calculated.
Analysis population: ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.
Groups in this outcome
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
Brigatinib 90 mg - 180 mg
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
| Group | Source count |
|---|---|
| Brigatinib 90 mg | 112 |
| Brigatinib 90 mg - 180 mg | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brigatinib 90 mg | 51.8 | Not reported | 42.1 | 61.3 | Not reported |
| Brigatinib 90 mg - 180 mg | 56.4 | Not reported | 46.6 | 65.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.1
- upper Limit
- 61.3
- value
- 51.8
- group Id
- OG001
- lower Limit
- 46.6
- upper Limit
- 65.8
- value
- 56.4
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- ORR assessed by the IRC, was defined as the percentage of the participants with CR or PR according to RECIST v1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. 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 norrmalization of tumor marker level. PR: at least a 30% decrease in theSLD of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 95% confidence interval was calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
- id
- OG000
- title
- Brigatinib 90 mg
- description
- Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
- id
- OG001
- title
- Brigatinib 90 mg - 180 mg
- param Type
- NUMBER
- population Description
- ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.
- reporting Status
- POSTED
- time Frame
- Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered Cycle of 28-days) through 15 Cycles and every 3 Cycles thereafter until disease progression or up to end of the study (approximately up to 69 months)
- title
- Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice