TriangleNCT03848845 · OUTCOME
Part 2 - Changes From Baseline in Urine Specific Gravity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and until end of treatment (up to 178 weeks)
What was measured
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date
Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
Groups in this outcome
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 25 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 25 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 1.0171 | 0.00965 | Not reported | Not reported | Not reported |
End of Treatment
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | -0.0001 | 0.00813 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.00965
- value
- 1.0171
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.00813
- value
- -0.0001
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- title
- End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
- id
- OG000
- title
- Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
- param Type
- MEAN
- population Description
- All Treated Population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and until end of treatment (up to 178 weeks)
- title
- Part 2 - Changes From Baseline in Urine Specific Gravity
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice