TriangleNCT03168438 · OUTCOME
Time to Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to 108 weeks
What was measured
Time to response is defined as the time interval (in months) from T-cell infusion to initial date of documented confirmed response (PR or better) in the subset of participants who showed a confirmed BOR of PR or better by Investigator assessment per IMWG (2016).
Analysis population: Modified ITT Population. Only those participants with a confirmed response per IMWG 2016 were analyzed.
Groups in this outcome
GSK3377794
Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
GSK3377794+Pembrolizumab
Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
| Group | Source count |
|---|---|
| GSK3377794 | 1 |
| GSK3377794+Pembrolizumab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK3377794 | 0.7 | Not reported | NA | NA | Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual time to response for this single participant. |
| GSK3377794+Pembrolizumab | 0.7 | Not reported | 0.7 | 0.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual time to response for this single participant.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.7
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 0.7
- value
- 0.7
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Time to response is defined as the time interval (in months) from T-cell infusion to initial date of documented confirmed response (PR or better) in the subset of participants who showed a confirmed BOR of PR or better by Investigator assessment per IMWG (2016).
- dispersion Type
- Full Range
- groups
- description
- Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
- id
- OG000
- title
- GSK3377794
- description
- Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
- id
- OG001
- title
- GSK3377794+Pembrolizumab
- param Type
- MEDIAN
- population Description
- Modified ITT Population. Only those participants with a confirmed response per IMWG 2016 were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 108 weeks
- title
- Time to Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice