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 @ 4:42 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT03602066
Description: CTCAE items collected include generalized weakness, skin reaction, weight loss, dry mouth, sore throat, dysphagia, anorexia, dysgeusia, voice alteration, and neck edema. These are common adverse events associated with radiation treatments. There were no adverse events related to the chloride dioxide mouthwash.
Frequency Threshold: 0
Time Frame: Adverse events were collected during the treatment period. Subjects were seen once per week per standard of care for on-treatment visits. Radiation treatments may be 6 or 7 weeks at the discretion of the treating physician. Vital signs and weight measurement along with grading of common head and neck side effects per common terminology criteria for adverse events (CTCAE v5.0) were performed.
Study: NCT03602066
Study Brief: Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Chlorine Dioxide Sterilization) Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment. Chlorine Dioxide Sterilization: Given via oral rinse Laboratory Biomarker Analysis: Correlative studies 0 None 0 6 6 6 View
Arm II (Placebo) Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment. Laboratory Biomarker Analysis: Correlative studies Placebo: Given via oral rinse 0 None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neck edema SYSTEMATIC_ASSESSMENT General disorders None View
Generalized weakness SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View