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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT02334358
Description: None
Frequency Threshold: 5
Time Frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Study: NCT02334358
Study Brief: Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
YVOIRE Classic s Treatment with YVOIRE Classic s YVOIRE Classic s 0 None 10 503 55 503 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Extremity injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Endometrial lesion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gastric polyps NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung cancer NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cervical intraepithelial neoplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Polyps of duodenum NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ectopic pregnancy NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View