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 |
|---|---|---|---|---|---|---|---|---|
| Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1 | Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) | 0 | None | 0 | 2 | 0 | 2 | View |
| Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone | Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels) | 0 | None | 0 | 3 | 0 | 3 | View |