TriangleNCT07217119 · OUTCOME
CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Baseline (Day 1) and up to approximately 281 weeks.
What was measured
Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: 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.
Analysis population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.
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 | 0 |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 0 |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: 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.
- 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
- population Description
- No participants were enrolled as CE Phase was not initiated due to business strategic reason.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 281 weeks.
- title
- CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice