TriangleNCT01539083 · OUTCOME
Overall Survival (OS)
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 5 years
What was measured
OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
Analysis population: All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) 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] | 100 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | NA | Not reported | NA | NA | Median and 95% CI was not estimable due to insufficient number of events. |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | NA | Not reported | NA | NA | Median and 95% CI was not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 103
- units
- Participants
- description
- OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice