Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DryNites Arm | Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night. DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase. | 0 | None | 0 | 35 | 1 | 35 | View |
| No Pants Arm | Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night. | 0 | None | 1 | 70 | 4 | 70 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| subglottic laryngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| subglottic laryngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| genital candidiasis, | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| pharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |