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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT04225260
Description: None
Frequency Threshold: 1
Time Frame: 12 months
Study: NCT04225260
Study Brief: Long-term Treatment of Moderate to Severe Glabellar Lines and 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
QM1114-DP in the LCL and the GL Areas The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. botulinum toxin neuromodulator: A dose of QM1114-DP will be injected in the GL area and in the LCL area. 1 None 23 902 243 902 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adnocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cubital tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post procedural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pelvic Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View