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 @ 3:22 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT02682992
Description: Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Frequency Threshold: 0
Time Frame: Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Study: NCT02682992
Study Brief: Low-Level Laser Therapy for Prevention of Oral Mucositis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Level Laser Therapy Patients that received prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices. Low Level Laser Therapy: LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J. 7 None 18 47 47 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Oral Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
dermatitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oral Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
dermatitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View