TriangleNCT02812706 · OUTCOME
Phase 1: 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 drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
What was measured
An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as 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, was a medically important event. TEAEs were defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).
Analysis population: Analysis was performed on all treated population.
Groups in this outcome
Phase 1, Cohort 1: Isatuximab 10 mg/kg
Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
Phase 1, Cohort 2: Isatuximab 20 mg/kg
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
| Group | Source count |
|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 3 |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 5 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as 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, was a medically important event. TEAEs were defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).
- groups
- description
- Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
- id
- OG000
- title
- Phase 1, Cohort 1: Isatuximab 10 mg/kg
- description
- Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
- id
- OG001
- title
- Phase 1, Cohort 2: Isatuximab 20 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Analysis was performed on all treated population.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
- title
- Phase 1: 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-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice