TriangleNCT01539083 · OUTCOME
Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Month 12
What was measured
CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
Analysis population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
Groups in this outcome
Thalidomide + Prednisolone [TP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
| Group | Source count |
|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 96 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 81.3 | Not reported | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 92.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 81.3
- group Id
- OG001
- value
- 92.9
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
- groups
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG000
- title
- Thalidomide + Prednisolone [TP Consolidation]
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG001
- title
- Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
- param Type
- NUMBER
- population Description
- All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
- reporting Status
- POSTED
- time Frame
- Month 12
- title
- Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice