TriangleNCT01286077 · OUTCOME
Number of Patients With Skeletal Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to end of study (approximately 4 years 7 months)
What was measured
Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period
Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Groups in this outcome
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control
no treatment, observation only
| Group | Source count |
|---|---|
| Bortezomib | 42 |
| Non-treated Control | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-treated Control | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period
- groups
- description
- bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
- id
- OG000
- title
- Bortezomib
- description
- no treatment, observation only
- id
- OG001
- title
- Non-treated Control
- param Type
- NUMBER
- population Description
- FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of study (approximately 4 years 7 months)
- title
- Number of Patients With Skeletal Events
- type
- SECONDARY
- unit Of Measure
- patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice