TriangleNCT03470922 · OUTCOME
The Number of Participants Experiencing Serious Adverse Events (SAEs)
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 to 30 days after last dose of study therapy (up to approximately 33 months)
What was measured
The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Analysis population: All treated participants
Groups in this outcome
Arm A: Relatlimab + Nivolumab
Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
Arm B: Nivolumab
Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
| Group | Source count |
|---|---|
| Arm A: Relatlimab + Nivolumab | 355 |
| Arm B: Nivolumab | 359 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Relatlimab + Nivolumab | 121 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Nivolumab | 105 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 105
- denoms
- counts
- group Id
- OG000
- value
- 355
- group Id
- OG001
- value
- 359
- units
- Participants
- description
- The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
- groups
- description
- Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
- id
- OG000
- title
- Arm A: Relatlimab + Nivolumab
- description
- Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
- id
- OG001
- title
- Arm B: Nivolumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
- title
- The Number of Participants Experiencing Serious Adverse Events (SAEs)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice