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 |
|---|---|---|---|---|---|---|---|---|
| Study Group | Received 4th dose of the Pentacel® series before 2nd birthday | None | None | 93 | 3213 | 0 | 3123 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 6.0 | View |
| Injury, poisoning and procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 6.0 | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 6.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 6.0 | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 6.0 | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 6.0 | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 6.0 | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 6.0 | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 6.0 | View |