NCT05255601 · OUTCOME
Number of Participants With Adverse Events (AEs) - Part A
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 135 days post last dose (Up to approximately 11 months)
What was measured
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Analysis population: All treated participants in part A
Groups in this outcome
Part A - Flat Dosing (AF)
Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
Part A - Age/Weight-based Dosing (AW)
Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
| Group | Source count |
|---|---|
| Part A - Flat Dosing (AF) | 4 |
| Part A - Age/Weight-based Dosing (AW) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - Flat Dosing (AF) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A - Age/Weight-based Dosing (AW) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
- groups
- description
- Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
- id
- OG000
- title
- Part A - Flat Dosing (AF)
- description
- Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
- id
- OG001
- title
- Part A - Age/Weight-based Dosing (AW)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in part A
- reporting Status
- POSTED
- time Frame
- From first dose to 135 days post last dose (Up to approximately 11 months)
- title
- Number of Participants With Adverse Events (AEs) - Part A
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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