NCT00215943 · OUTCOME
Overall Survival (OS), by Treatment Arm
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to 10 Years
What was measured
Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive. Investigators had planned to accrue 176 participants to calculate median overall survival.
Analysis population: All participants with evaluable follow-up data.
Groups in this outcome
Active Comparator: VAD Treatment
VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
Active Comparator: Thalidomide and Dexamethasone Treatment
Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
| Group | Source count |
|---|---|
| Active Comparator: VAD Treatment | 26 |
| Active Comparator: Thalidomide and Dexamethasone Treatment | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: VAD Treatment | 57 | Not reported | 0 | 114 | Not reported |
| Active Comparator: Thalidomide and Dexamethasone Treatment | 56.5 | Not reported | 2 | 115 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 114
- value
- 57
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 115
- value
- 56.5
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive. Investigators had planned to accrue 176 participants to calculate median overall survival.
- dispersion Type
- Full Range
- groups
- description
- VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
- id
- OG000
- title
- Active Comparator: VAD Treatment
- description
- Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
- id
- OG001
- title
- Active Comparator: Thalidomide and Dexamethasone Treatment
- param Type
- MEDIAN
- population Description
- All participants with evaluable follow-up data.
- reporting Status
- POSTED
- time Frame
- Up to 10 Years
- title
- Overall Survival (OS), by Treatment Arm
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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