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 |
|---|---|---|---|---|---|---|---|---|
| Inactivated Polio Vaccine (IPV) | The control group received inactivated poliovirus vaccine (IPV) at the age of 6 and 12 months and 2, 6, and 9-12 years according to the national immunization protocol in Finland at that time. | 0 | None | 0 | 251 | 0 | 251 | View |
| Oral Polio Vaccine (OPV) | Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommended to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years. Oral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV). | 0 | None | 0 | 64 | 0 | 64 | View |