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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT01488318
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01488318
Study Brief: Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CETUXIMAB + DASATINIB Cetuximab dosed at 250 mg/m\^2/week and Dasatinib dosed at 150 mg daily 8 None 8 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury to carotid artery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngeal hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Facial pain SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint range of motion decreased cervical spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Movements involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Body odor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fibrosis deep connective tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View