TriangleNCT03548207 · OUTCOME
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 up to 45.2 months
What was measured
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Analysis population: All treated analysis set included all participants who received JNJ-68284528 infusion.
Groups in this outcome
Phase 2 (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
| Group | Source count |
|---|---|
| Phase 2 (US Population) | 68 |
| Phase 2 (Japan Population) | 9 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 (Japan Population) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 (Japan Population) | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 (Japan Population) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 58 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 (Japan Population) | 8 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (US Population) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 (Japan Population) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 8
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
- groups
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG000
- title
- Phase 2 (US Population)
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG001
- title
- Phase 2 (Japan Population)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated analysis set included all participants who received JNJ-68284528 infusion.
- reporting Status
- POSTED
- time Frame
- Day 1 up to 45.2 months
- title
- Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice