NCT04472377 · 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
- 1 months
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Participants With Adverse Events | 0 / 1210 | 9 / 1210 | 0 / 1210 |
Serious adverse events
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Product Issues
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 1210
- term
- Perineal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Product Issues
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 1210
- term
- anxiety
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 1210
- description
- study device-related adverse events
- id
- EG000
- other Num Affected
- 9
- other Num At Risk
- 1210
- serious Num Affected
- 0
- serious Num At Risk
- 1210
- title
- Participants With Adverse Events
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Product Issues
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 1210
- term
- Perineal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Product Issues
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 1210
- term
- anxiety
- time Frame
- 1 months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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