NCT02516696 · OUTCOME
Survival Duration Without Disease Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Until disease progression or death from any cause, for a maximum of approximately 5 years
What was measured
Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen. Progression is determined by the International Myeloma Working Group Criteria.
Groups in this outcome
BiRD Treatment Regimen
Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Rd Treatment Regimen
Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
| Group | Source count |
|---|---|
| BiRD Treatment Regimen | 7 |
| Rd Treatment Regimen | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BiRD Treatment Regimen | 661 | Not reported | 586 | NA | Some participants were still alive without disease progression at the time of study completion. |
| Rd Treatment Regimen | 1694 | Not reported | 821 | NA | Some participants were still alive without disease progression at the time of study completion. |
Complete source fields
- classes
- categories
- measurements
- comment
- Some participants were still alive without disease progression at the time of study completion.
- group Id
- OG000
- lower Limit
- 586
- upper Limit
- NA
- value
- 661
- comment
- Some participants were still alive without disease progression at the time of study completion.
- group Id
- OG001
- lower Limit
- 821
- upper Limit
- NA
- value
- 1694
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen. Progression is determined by the International Myeloma Working Group Criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
- id
- OG000
- title
- BiRD Treatment Regimen
- description
- Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
- id
- OG001
- title
- Rd Treatment Regimen
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Until disease progression or death from any cause, for a maximum of approximately 5 years
- title
- Survival Duration Without Disease Progression
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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