TriangleNCT01871805 · OUTCOME
Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II
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
- Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
What was measured
CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.
Analysis population: Phase II safety population. 'Overall Number of Participants Analyzed' = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.
Groups in this outcome
Alectinib 600 mg (Fed): Phase II
Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
| Group | Source count |
|---|---|
| Alectinib 600 mg (Fed): Phase II | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 600 mg (Fed): Phase II | 54.5 | Not reported | 23.38 | 83.25 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.38
- upper Limit
- 83.25
- value
- 54.5
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG000
- title
- Alectinib 600 mg (Fed): Phase II
- param Type
- NUMBER
- population Description
- Phase II safety population. 'Overall Number of Participants Analyzed' = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.
- reporting Status
- POSTED
- time Frame
- Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
- title
- Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice