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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT02324335
Description: Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
Frequency Threshold: 5
Time Frame: AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Study: NCT02324335
Study Brief: Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Oral Rinse Water for Injection Placebo: Oral Rinse used 3 times daily for 7 weeks 0 None 5 30 30 30 View
Active Oral Rinse Brilacidin 3 mg/mL in Water for Injection Brilacidin: Oral Rinse used 3 times daily for 7 weeks 0 None 8 29 29 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0. View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0. View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0. View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 20.0. View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0. View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0. View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0. View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0. View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0. View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0. View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0. View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0. View
Catheter site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0. View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 20.0. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0. View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0. View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Saliva altered SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0. View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0. View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0. View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0. View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0. View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0. View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 20.0. View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0. View