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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT02278718
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: 1
Time Frame: Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study.
Study: NCT02278718
Study Brief: A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
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 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\^2 of TBSA for four hours. NexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal. 0 None 2 69 31 69 View
Standard of Care Non surgical and Surgical Debridement Standard of Care: Surgical or Non-Surgical methods for Eschar Removal 0 None 6 70 30 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Joint Contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Systemic Inflammatory Response Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Withdrawal Syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bromhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View