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 |
|---|---|---|---|---|---|---|---|---|
| GSK2036874A Group 1 | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 0 | None | 1 | 78 | 75 | 78 | View |
| GSK2036874A Group 2 | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 0 | None | 3 | 78 | 74 | 78 | View |
| GSK2036874A Group 3 | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 0 | None | 2 | 78 | 76 | 78 | View |
| Zilbrix/Hib/Poliorix Group | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. | 0 | None | 1 | 78 | 77 | 78 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |