TriangleNCT06160609 · OUTCOME
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
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 170 weeks
What was measured
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse Events of Special Interest (whether serious or non serious) were collected.
Analysis population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 8mg OX40
Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
2.5 mg/kg Belantamab Mafodotin + 8mg OX40
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
| Group | Source count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse Events of Special Interest (whether serious or non serious) were collected.
- groups
- description
- Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 8mg OX40
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
- id
- OG001
- title
- 2.5 mg/kg Belantamab Mafodotin + 8mg OX40
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population included all participants who received at least 1 dose of any component of the combination therapy.
- reporting Status
- POSTED
- time Frame
- Up to 170 weeks
- title
- DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice