TriangleNCT05405166 · OUTCOME
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of successful injections
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
What was measured
Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
Analysis population: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. Total number of actual injections is reported as type of units.
Groups in this outcome
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-SC + Pd | 263 |
| Group | Source count |
|---|---|
| Isa-SC + Pd | 7584 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-SC + Pd | 99.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.0
- denom Units Selected
- Actual injections
- denoms
- counts
- group Id
- OG000
- value
- 263
- units
- Participants
- counts
- group Id
- OG000
- value
- 7584
- units
- Actual injections
- description
- Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
- groups
- 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
- OG000
- title
- Isa-SC + Pd
- param Type
- NUMBER
- population Description
- The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. Total number of actual injections is reported as type of units.
- reporting Status
- POSTED
- time Frame
- From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
- title
- Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
- type
- SECONDARY
- type Units Analyzed
- Actual injections
- unit Of Measure
- percentage of successful injections
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice