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 |
|---|---|---|---|---|---|---|---|---|
| Arthroscopic Partial Meniscectomy | Standard arthroscopic partial meniscectomy - NGD 1 Arthroscopic partial menisectomy: Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. Adverse events related to the surgical procedure; i.e. lung embolus, infection, acute heart attac. | 0 | None | 0 | 70 | 0 | 70 | View |
| Exercise Therapy | Supervised neuromuscular- and strength training Supervised neuromuscular and strength training: Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum Adverse events related to the exercise; i.e. heart- og lung disease, trauma | 0 | None | 0 | 70 | 0 | 70 | View |