Adverse Events Module

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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: NCT03911102
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 after LCL treatment.
Study: NCT03911102
Study Brief: Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1: DAXI 12 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) 0 None 0 15 6 15 View
Cohort 2: DAXI 24 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) 0 None 1 17 7 17 View
Cohort 3: DAXI 36 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) 0 None 0 15 7 15 View
Cohort 4: DAXI 48 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) 0 None 0 16 6 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mastitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injury associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil percentage increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site oedema SYSTEMATIC_ASSESSMENT General disorders None View