TriangleNCT03848845 · OUTCOME
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
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 178 weeks
What was measured
The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.
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 | 10 |
Reported measurements
Resolved prior to end of treatment exposure
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 7 | Not reported | Not reported | Not reported | Not reported |
Resolved post end of treatment exposure
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 2 | Not reported | Not reported | Not reported | Not reported |
Not resolved
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Resolved prior to end of treatment exposure
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Resolved post end of treatment exposure
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Not resolved
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 178 weeks
- title
- Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice