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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT02159703
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT02159703
Study Brief: A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal 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
Single Arm Phase 2 TORS Adjuvant Radiation Therapy 0 None 18 60 43 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dermatitits radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Ear and labyrinth disorders NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema face NON_SYSTEMATIC_ASSESSMENT General disorders None View
Esophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Laryngeal edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lip pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mucosal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Musculoskeletal and connective tissue disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Salivary duct inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Superficial soft tissue fibrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trismus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Voice alteration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View