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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT02148705
Description: An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Frequency Threshold: 3
Time Frame: Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study.
Study: NCT02148705
Study Brief: A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NexoBrid Gel NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid 2 None 9 77 49 77 View
Gel Vehicle Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle 0 None 3 24 16 24 View
Standard of Care (SOC) Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC) 0 None 9 68 39 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Septal Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Congenital Tricuspid Valve Incompetence SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Laryngomalacia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Patent Ductus Arteriosus SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Persistent Fetal Circulation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Trisomy 21 SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Ventricular Septal Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Glioblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous Cell Carcinoma of the Oral Cavity SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral Ventricle Dilatation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Failure to Thrive SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neonatal Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Transient Tachypnoea of the Newborn SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eventration Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bifascicular Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Appendicitis Noninfective SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Infusion Site Thrombosis SYSTEMATIC_ASSESSMENT General disorders None View
Wound Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium Difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thermal Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Graft Loss SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diabetic Metabolic Decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Internal Fixation of Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Therapeutic Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Phlebitis Superficial SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Graft Loss SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint Range of Motion Decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Wound Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View