TriangleNCT05405166 · OUTCOME
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- minutes
- Interval / dispersion
- Full Range
- Time frame
- From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
What was measured
Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
Analysis population: The ITT population included all randomized population.
Groups in this outcome
Isa-IV + Pd
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
| Group | Source count |
|---|---|
| Isa-IV + Pd | 268 |
| Isa-SC + Pd | 263 |
Reported measurements
Duration of hospital visit
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-IV + Pd | 240.00 | Not reported | 1.0 | 500.0 | Not reported |
| Isa-SC + Pd | 180.00 | Not reported | 1.0 | 600.0 | Not reported |
Duration of post-treatment monitoring
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-IV + Pd | 30.00 | Not reported | 1.0 | 500.0 | Not reported |
| Isa-SC + Pd | 30.00 | Not reported | 1.0 | 500.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 500.0
- value
- 240.00
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 600.0
- value
- 180.00
- title
- Duration of hospital visit
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 500.0
- value
- 30.00
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 500.0
- value
- 30.00
- title
- Duration of post-treatment monitoring
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
- dispersion Type
- Full Range
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG000
- title
- Isa-IV + Pd
- description
- Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG001
- title
- Isa-SC + Pd
- param Type
- MEDIAN
- population Description
- The ITT population included all randomized population.
- reporting Status
- POSTED
- time Frame
- From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
- title
- Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
- type
- SECONDARY
- unit Of Measure
- minutes
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Preserved source evidence · Not medical advice