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: 2025-12-26 @ 2:41 PM
Ignite Modification Date: 2025-12-26 @ 2:41 PM
NCT ID: NCT00492206
Description: Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)
Frequency Threshold: 5
Time Frame: None
Study: NCT00492206
Study Brief: Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks. None None 11 40 38 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders None View
Supraventricular and nodal arrhythmia, Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Allergic reaction/hypersensitivity (including drug fever) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Constitutional Symptoms - Other (Specify, __) SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain, Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic reaction/hypersensitivity (including drug fever) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Supraventricular and nodal arrhythmia, Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular and nodal arrhythmia, Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constitutional Symptoms - Other (Specify, __) SYSTEMATIC_ASSESSMENT General disorders None View
Sweating (diaphoresis) SYSTEMATIC_ASSESSMENT General disorders None View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders None View
Dermatology/Skin - Other (Specify, __) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: dermatitis associated with radiation, Chemoradiation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: hand-foot skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair loss/alopecia (scalp or body) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: dermatitis associated with radiation, Radiation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal - Other (Specify, __) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Taste alteration (dysgeusia) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis/stomatitis (clinical exam), Oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia (difficulty swallowing) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage/Bleeding - Other (Specify, __) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Other (Specify, __) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS SYSTEMATIC_ASSESSMENT Infections and infestations None View
AST, SGOT(serum glutamic oxaloacetic transaminase) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Magnesium, serum-low (hypomagnesemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Calcium, serum-low (hypocalcemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Phosphate, serum-low (hypophosphatemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Albumin, serum-low (hypoalbuminemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose, serum-high (hyperglycemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal/Soft Tissue - Other (Specify, __) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mood alteration, Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurology - Other (Specify, __) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy: motor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood alteration, Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope (fainting) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders None View
Watery eye (epiphora, tearing) SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain - Other (Specify, __) SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Throat/pharynx/larynx SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Chest/thorax NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Muscle SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Bone SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Extremity-limb SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Joint SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Back SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Head/headache SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis/pulmonary infiltrates SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary/Upper Respiratory - Other (Specify, __) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View