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 |
|---|---|---|---|---|---|---|---|---|
| OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects. | None | None | 0 | 31 | 20 | 31 | View |
| Placebo | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects. | None | None | 0 | 31 | 5 | 31 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| decrease appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Irritable | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| stomachaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| prone to crying | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Bites Fingernails | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tics/Nervous movements | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |