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 |
|---|---|---|---|---|---|---|---|---|
| Age Group 1: Children (3-11 Years) | Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly. | 0 | None | 0 | 60 | 59 | 60 | View |
| Age Group 2: Adolescents (12-18 Years) | Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. | 0 | None | 0 | 60 | 56 | 60 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| vaccination site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| vaccination site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| vaccination site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| vaccination site induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| vaccination site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| helminthic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |