TriangleNCT01602224 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to Death From Any Cause (assessed up to 19 months)
What was measured
Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact.
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 | NA | Not reported | 19.1 | NA | Medians were not reached for timeframe |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | NA | Not reported | NA | NA | Medians were not reached for timeframe |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | NA | Not reported | 18.6 | NA | Medians were not reached for timeframe |
Complete source fields
- classes
- categories
- measurements
- comment
- Medians were not reached for timeframe
- group Id
- OG000
- lower Limit
- 19.1
- upper Limit
- NA
- value
- NA
- comment
- Medians were not reached for timeframe
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Medians were not reached for timeframe
- group Id
- OG002
- lower Limit
- 18.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline to Death From Any Cause (assessed up to 19 months)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice