TriangleNCT01602224 · OUTCOME
Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain 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
- Baseline through End of Treatment (19 months)
What was measured
BPI is assessed by 7 questions rated "0" for "no pain" and higher numbers indicated more pain.
Analysis population: All randomized participants.
Groups in this outcome
100 mg Tabalumab+Dexamethasone+Bortezomib
Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
300 mg Tabalumab+Dexamethasone+Bortezomib
Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
Placebo Comparator: Placebo + Dexamethasone + Bortezomib
Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
| Group | Source count |
|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 74 |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 74 |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 37 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 30 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 30 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- BPI is assessed by 7 questions rated "0" for "no pain" and higher numbers indicated more pain.
- groups
- description
- Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG000
- title
- 100 mg Tabalumab+Dexamethasone+Bortezomib
- description
- Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG001
- title
- 300 mg Tabalumab+Dexamethasone+Bortezomib
- description
- Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG002
- title
- Placebo Comparator: Placebo + Dexamethasone + Bortezomib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline through End of Treatment (19 months)
- title
- Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice