TriangleNCT00424047 · OUTCOME
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to unblinding data cut off of 03 August 2005; up to 24 months
What was measured
Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
Analysis population: Analysis not performed due to an insufficient number of participants with SRE
Groups in this outcome
Lenalidomide Plus Dexamethasone
Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
Placebo Plus Dexamethasone
Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
| Group | Source count |
|---|---|
| Lenalidomide Plus Dexamethasone | 176 |
| Placebo Plus Dexamethasone | 175 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Plus Dexamethasone | NA | Not reported | Not reported | Not reported | There were an insufficient number of participants with SRE events and no analysis was conducted. |
| Placebo Plus Dexamethasone | NA | Not reported | Not reported | Not reported | There were an insufficient number of participants with SRE events and no analysis was conducted. |
Complete source fields
- classes
- categories
- measurements
- comment
- There were an insufficient number of participants with SRE events and no analysis was conducted.
- group Id
- OG000
- value
- NA
- comment
- There were an insufficient number of participants with SRE events and no analysis was conducted.
- group Id
- OG001
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
- groups
- description
- Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
- id
- OG000
- title
- Lenalidomide Plus Dexamethasone
- description
- Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
- id
- OG001
- title
- Placebo Plus Dexamethasone
- param Type
- NUMBER
- population Description
- Analysis not performed due to an insufficient number of participants with SRE
- reporting Status
- POSTED
- time Frame
- Up to unblinding data cut off of 03 August 2005; up to 24 months
- title
- Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice