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
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
NCT ID:
NCT03821402
Description:
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
Frequency Threshold:
5
Time Frame:
The adverse events were collected throughout the entire study, up to 36 weeks.
Study:
NCT03821402
Study Brief:
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DAXI 250 U | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U | 0 | None | 2 | 22 | 4 | 22 | View |
| DAXI 375 U | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U | 0 | None | 0 | 19 | 12 | 19 | View |
| DAXI 500 U | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U | 0 | None | 1 | 18 | 6 | 18 | View |
| Placebo | Placebo group | 0 | None | 2 | 24 | 4 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site hematoma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Heat stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Urine analysis abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myofascial pain syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Trigger finger | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cervical radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Blood blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tooth extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |