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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT01344356
Description: Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT01344356
Study Brief: Stereotactic Body Radiotherapy for Head and Neck Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Benign Tumors Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction) 0 None 0 1 1 1 View
Malignant Tumors Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction) 8 None 0 8 5 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hoarseness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Musculoskeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Cranial Nerve Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View