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 |
|---|---|---|---|---|---|---|---|---|
| Autologous Fibroblasts | Patients treated with autologous fibroblasts (azficel-T). | None | None | 8 | 98 | 32 | 98 | View |
| Placebo | Patients treated with placebo solution. | None | None | 7 | 99 | 33 | 99 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Spinal Column Stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Endometriosis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Cervical Vertebral Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Nephrectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (Unspecified) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Rib Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Impaired Gastric Emptying | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Uterine Leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Subarachnoid Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (Unspecified) | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Retinal Detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Staphylococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |