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 |
|---|---|---|---|---|---|---|---|---|
| Botulinum Toxin Type A - Part A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo. Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. | 0 | None | 5 | 252 | 0 | 252 | View |
| Placebo - Part A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo. | 0 | None | 1 | 83 | 0 | 83 | View |
| Botulinum Toxin Type A - Part B | Part B was open-label, active treatment to all participants up to 1 year. The retreatment, or first treatment if randomized to placebo, injection defines for each subject the start of Part B. | 0 | None | 11 | 326 | 0 | 326 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Adjustment disorder with depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Deafness unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Urinary bladder polyp | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Benign uterine neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Cystocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Fibroadenoma of breast | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Deafness transitory | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |