NCT00819832 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- 15 months
- Other-event reporting threshold
- 5%
No patients were enrolled in other groups or Phase II.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Phase 1 Group 1 Vertebroplasty | 0 / 3 | 0 / 3 | Not reported / Not reported |
| Phase 1 Group 2 Kyphoplasty | 0 / 0 | 0 / 0 | Not reported / Not reported |
| Phase 2 Group 1 Vertebroplasty | 0 / 0 | 0 / 0 | Not reported / Not reported |
| Phase 2 Group 2 Vertebroplasty +Cavity SpineWand | 0 / 0 | 0 / 0 | Not reported / Not reported |
| Phase 2 Group 3 Kyphoplasty | 0 / 0 | 0 / 0 | Not reported / Not reported |
| Phase 2 Group 4 Kyphoplasty + Cavity SpineWand | 0 / 0 | 0 / 0 | Not reported / Not reported |
Serious adverse events
Other reported adverse events
Complete source fields
- description
- No patients were enrolled in other groups or Phase II.
- event Groups
- description
- Vertebroplasty
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Phase 1 Group 1 Vertebroplasty
- description
- Kyphoplasty
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Phase 1 Group 2 Kyphoplasty
- description
- Vertebroplasty
- id
- EG002
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Phase 2 Group 1 Vertebroplasty
- description
- Vertebroplasty with Cavity SpineWand
- id
- EG003
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Phase 2 Group 2 Vertebroplasty +Cavity SpineWand
- description
- Kyphoplasty
- id
- EG004
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Phase 2 Group 3 Kyphoplasty
- description
- Kyphoplasty with Cavity SpineWand
- id
- EG005
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Phase 2 Group 4 Kyphoplasty + Cavity SpineWand
- frequency Threshold
- 5
- time Frame
- 15 months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle