TriangleNCT05405166 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Analysis population: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication.
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 | 264 |
| Isa-SC + Pd | 263 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-IV + Pd | 263 | Not reported | Not reported | Not reported | Not reported |
| Isa-SC + Pd | 258 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Isa-IV + Pd | 152 | Not reported | Not reported | Not reported | Not reported |
| Isa-SC + Pd | 160 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 263
- group Id
- OG001
- value
- 258
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 160
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 264
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
- 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
- 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.
- 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
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice