TriangleNCT03848845 · OUTCOME
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
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
- Baseline (Day 1) and up to approximately 178 weeks
What was measured
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Analysis population: All Treated Population
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 | 28 |
Reported measurements
DBP, Any Grade Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 20 | Not reported | Not reported | Not reported | Not reported |
DBP, Increase to Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 12 | Not reported | Not reported | Not reported | Not reported |
DBP, Increase to Grade 3
| 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 |
SBP, Any Grade Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 24 | Not reported | Not reported | Not reported | Not reported |
SBP, Increase to Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 16 | Not reported | Not reported | Not reported | Not reported |
SBP, Increase to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- title
- DBP, Any Grade Increase
- categories
- measurements
- group Id
- OG000
- value
- 12
- title
- DBP, Increase to Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- DBP, Increase to Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 24
- title
- SBP, Any Grade Increase
- categories
- measurements
- group Id
- OG000
- value
- 16
- title
- SBP, Increase to Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- SBP, Increase to Grade 3
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- description
- DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are 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
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 178 weeks
- title
- Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice