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 |
|---|---|---|---|---|---|---|---|---|
| PedvaxHIB Arm | Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children. | 0 | None | 12 | 166 | 0 | 0 | View |
| Vaxelis | Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children. | 0 | None | 9 | 167 | 0 | 0 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Serizure, or seizure-like activity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Viral illness with hypoxia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Broken Femur | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |