TriangleNCT03470922 · OUTCOME
The Number of Participants Experiencing Adverse Events (AEs)
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 adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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 | 345 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Nivolumab | 339 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 345
- group Id
- OG001
- value
- 339
- denoms
- counts
- group Id
- OG000
- value
- 355
- group Id
- OG001
- value
- 359
- units
- Participants
- description
- The number of participants experiencing adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
- 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 Adverse Events (AEs)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice