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 @ 3:10 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT00400205
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00400205
Study Brief: Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy. 3 None 6 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoxemia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PEG tube infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty speaking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders xerostomia View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Facial pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vision disturbance NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mouth sores NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mouth pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View