NCT00103506 · 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
- Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)
What was measured
The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Groups in this outcome
Velcade (Bortezomib) Monotherapy
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib)
Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
| Group | Source count |
|---|---|
| Velcade (Bortezomib) Monotherapy | 322 |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 324 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade (Bortezomib) Monotherapy | 30.8 | Not reported | 25.2 | 36.5 | Not reported |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 33.0 | Not reported | 28.9 | 37.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.2
- upper Limit
- 36.5
- value
- 30.8
- group Id
- OG001
- lower Limit
- 28.9
- upper Limit
- 37.1
- value
- 33.0
- denoms
- counts
- group Id
- OG000
- value
- 322
- group Id
- OG001
- value
- 324
- units
- Participants
- description
- The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
- id
- OG000
- title
- Velcade (Bortezomib) Monotherapy
- description
- Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
- id
- OG001
- title
- Doxil/Caelyx Plus Velcade (Bortezomib)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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