NCT03575351 · OUTCOME
Hospital Resource Utilization (HRU) Results
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
- Up to 36 months
What was measured
Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)
Analysis population: All participants treated in any study medication
Groups in this outcome
Standard of Care Arm
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Liso-cel Arm
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
| Group | Source count |
|---|---|
| Standard of Care Arm | 91 |
| Liso-cel Arm | 92 |
Reported measurements
Hospitalized
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 74 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 87 | Not reported | Not reported | Not reported | Not reported |
Hospitalized due to Adverse Event (AE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 42 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 44 | Not reported | Not reported | Not reported | Not reported |
Hospitalized due to Progression of Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 2 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 6 | Not reported | Not reported | Not reported | Not reported |
Hospitalized per protocol
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 11 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 22 | Not reported | Not reported | Not reported | Not reported |
Hospitalized due to other reasons
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 56 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 71 | Not reported | Not reported | Not reported | Not reported |
Admitted to Intensive Care Unit (ICU)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 4 | Not reported | Not reported | Not reported | Not reported |
| Liso-cel Arm | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 87
- title
- Hospitalized
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 44
- title
- Hospitalized due to Adverse Event (AE)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- Hospitalized due to Progression of Disease
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 22
- title
- Hospitalized per protocol
- categories
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 71
- title
- Hospitalized due to other reasons
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- title
- Admitted to Intensive Care Unit (ICU)
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)
- groups
- description
- 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
- id
- OG000
- title
- Standard of Care Arm
- description
- \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
- id
- OG001
- title
- Liso-cel Arm
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants treated in any study medication
- reporting Status
- POSTED
- time Frame
- Up to 36 months
- title
- Hospital Resource Utilization (HRU) Results
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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