TriangleNCT03430011 · OUTCOME
Time to Onset of Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- From JCARH125 infusion to the first onset of Grade ≥2 CRS (Up to approximately 61 months)
What was measured
Time to first onset of Grade ≥2 CRS in participants receiving prophylactic anakinra relative to onset of Grade ≥ 2 CRS in participants treated at the RP2D(s) in the Phase 1 dose escalation portion of the trial. Time to onset is calculated from the latest JCARH125 infusion prior to the first onset of Grade \>= 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
Analysis population: All participants with grade ≥2 CRS who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) at dose level 600 x 10\^6 in phase 1 and in phase 1 Anakinra
Groups in this outcome
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
| Group | Source count |
|---|---|
| Phase 1 600 x 10^6 Cells | 11 |
| Phase 1 Anakinra 600 x 10^6 Cells | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 600 x 10^6 Cells | 2.0 | Not reported | 1 | 3 | Not reported |
| Phase 1 Anakinra 600 x 10^6 Cells | 2.0 | Not reported | 2 | 3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 3
- value
- 2.0
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 3
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Time to first onset of Grade ≥2 CRS in participants receiving prophylactic anakinra relative to onset of Grade ≥ 2 CRS in participants treated at the RP2D(s) in the Phase 1 dose escalation portion of the trial. Time to onset is calculated from the latest JCARH125 infusion prior to the first onset of Grade \>= 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
- dispersion Type
- Full Range
- groups
- description
- JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG000
- title
- Phase 1 600 x 10^6 Cells
- description
- 2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG001
- title
- Phase 1 Anakinra 600 x 10^6 Cells
- param Type
- MEDIAN
- population Description
- All participants with grade ≥2 CRS who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) at dose level 600 x 10\^6 in phase 1 and in phase 1 Anakinra
- reporting Status
- POSTED
- time Frame
- From JCARH125 infusion to the first onset of Grade ≥2 CRS (Up to approximately 61 months)
- title
- Time to Onset of Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice