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: 2025-12-24 @ 4:25 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT00634166
Description: There is a change in the analysis sets that were used for analyzing efficacy-FA Set and Safety data- Safety set. Out of 138 patients enrolled, one patient had 'No post-graft assessments' and hence the patient was excluded from FAS- efficacy analysis. This resulted in a reduced number(one less) of patients for FAS. There is no analytical error. Reference -Table 14.1.3.1
Frequency Threshold: 5
Time Frame: None
Study: NCT00634166
Study Brief: Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Historical Control Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago) Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. None None 9 82 74 82 View
Prospective Patients/Active Drug Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. None None 27 138 130 138 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Multi-organ Failure SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Failure - acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Procedural Hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Culture Wound Positive SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Failure-acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View