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 |
|---|---|---|---|---|---|---|---|---|
| CFZ533 10 mg/kg | CFZ533 intravenously over approximately one hour | 0 | None | 1 | 15 | 12 | 15 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (20.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| CARDIAC MURMUR | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| ELECTROCARDIOGRAM QT PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| OSTEOPENIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |