TriangleNCT05405166 · OUTCOME
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
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
- From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
What was measured
The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the 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. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm.
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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-SC + Pd | 12 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 263
- units
- Participants
- description
- The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the 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
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm.
- reporting Status
- POSTED
- time Frame
- From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
- title
- Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice