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 |
|---|---|---|---|---|---|---|---|---|
| Infanrix Hexa PF Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 0 | None | 1 | 127 | 116 | 127 | View |
| Infanrix Hexa PC Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 0 | None | 2 | 137 | 126 | 137 | View |
| Control Group | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 0 | None | 1 | 139 | 129 | 139 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Fever/(Rectal) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |