TriangleNCT07084896 · OUTCOME
CE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
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 253 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. Adverse Events of Special Interest (whether serious or non serious) were collected.
Analysis population: Safety Population
Groups in this outcome
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, 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 until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
| Group | Source count |
|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 34 |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 28 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 31 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 37
- 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. Adverse Events of Special Interest (whether serious or non serious) were collected.
- groups
- description
- In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
- id
- OG000
- title
- CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
- description
- In CE Phase, 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 until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
- id
- OG001
- title
- CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 253 weeks
- title
- CE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice