TriangleNCT07084896 · OUTCOME
CE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
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
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
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
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 9 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 9 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 3 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 0 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 0 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat | 0 | Not reported | Not reported | Not reported | Not reported |
| CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
- 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 Any Corneal Event by Maximum Grade as Per CTCAE Grade
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice