NCT07217119 · OUTCOME
DE Phase: Number of Participants With 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
- Up to approximately 281 weeks
What was measured
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Analysis population: Safety population included all participants who received at least one dose of any component of the combination therapy.
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
| Group | Source count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 9 |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 10 |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 9 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 9 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG001
- title
- 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG002
- title
- 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least one dose of any component of the combination therapy.
- reporting Status
- POSTED
- time Frame
- Up to approximately 281 weeks
- title
- DE Phase: Number of Participants With Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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