TriangleNCT03168438 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to 108 weeks
What was measured
Progression Free Survival is defined as the interval between the date of T-cell infusion and the initial assessment date of confirmed progressive disease as assessed by the investigator per IMWG (2016) or date of death. Progressive disease is defined as an increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>=0.5 grams per deciliter (g/dL); Serum M-protein increase \>=1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>=200 mg per 24 hours).
Analysis population: Modified ITT Population
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 | 3 |
| GSK3377794+Pembrolizumab | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK3377794 | 2.79 | Not reported | 1.31 | 5.16 | Not reported |
| GSK3377794+Pembrolizumab | 2.78 | Not reported | 2.76 | 2.79 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.31
- upper Limit
- 5.16
- value
- 2.79
- group Id
- OG001
- lower Limit
- 2.76
- upper Limit
- 2.79
- value
- 2.78
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Progression Free Survival is defined as the interval between the date of T-cell infusion and the initial assessment date of confirmed progressive disease as assessed by the investigator per IMWG (2016) or date of death. Progressive disease is defined as an increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>=0.5 grams per deciliter (g/dL); Serum M-protein increase \>=1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>=200 mg per 24 hours).
- dispersion Type
- Inter-Quartile 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
- reporting Status
- POSTED
- time Frame
- Up to 108 weeks
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice