TriangleNCT02075840 · OUTCOME
CNS DOR IRC-assessed According to RECIST v1.1 Criteria
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
- First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
What was measured
CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
Analysis population: ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.
Groups in this outcome
Alectinib
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Crizotinib
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Alectinib | 21 |
| Crizotinib | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 17.3 | Not reported | 14.8 | NA | The upper limit of the CI for CNS DOR could not be estimated at time of the data cutoff for participants in the alectinib arm. |
| Crizotinib | 5.5 | Not reported | 2.1 | 17.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the CI for CNS DOR could not be estimated at time of the data cutoff for participants in the alectinib arm.
- group Id
- OG000
- lower Limit
- 14.8
- upper Limit
- NA
- value
- 17.3
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 17.3
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Alectinib
- description
- Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG001
- title
- Crizotinib
- param Type
- MEDIAN
- population Description
- ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.
- reporting Status
- POSTED
- time Frame
- First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
- title
- CNS DOR IRC-assessed According to RECIST v1.1 Criteria
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice