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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT03656133
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
Study: NCT03656133
Study Brief: Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiotherapy Fractionation Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart) 2 None 1 55 7 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Pharyngeal mucositis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View