TriangleNCT03828292 · OUTCOME
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
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 141 weeks
What was measured
The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Analysis population: All treated population.
Groups in this outcome
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
| Group | Source count |
|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
Reported measurements
Source class 1
0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 1 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
4-5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- 0
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- 1
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 2
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 4-5
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG000
- title
- Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
- description
- Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG001
- title
- Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated population.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 141 weeks
- title
- Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice