TriangleNCT03430843 · OUTCOME
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
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
- Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
What was measured
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Analysis population: The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis
Groups in this outcome
Tislelizumab
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
Investigator Chosen Chemotherapy
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
| Group | Source count |
|---|---|
| Tislelizumab | 21 |
| Investigator Chosen Chemotherapy | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab | 7.1 | Not reported | 2.9 | 13.2 | Not reported |
| Investigator Chosen Chemotherapy | 5.7 | Not reported | 1.2 | NA | Not estimable due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- 13.2
- value
- 7.1
- comment
- Not estimable due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
- id
- OG000
- title
- Tislelizumab
- description
- Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
- id
- OG001
- title
- Investigator Chosen Chemotherapy
- param Type
- MEDIAN
- population Description
- The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis
- reporting Status
- POSTED
- time Frame
- Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
- title
- Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice