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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT00530634
Description: "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold: 0
Time Frame: Adverse events were recorded over a period of 46 months.
Study: NCT00530634
Study Brief: Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung 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
Gemcitabine + Cisplatin Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy. None None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphangiopathy NOS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Lymphatic disorder NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Packed red blood cell transfusion NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Conduction disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Eye disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders meddra9.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
General symptom NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Oedema NOS NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Radiation oesophagitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications meddra9.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Musculoskeletal disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Myositis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Taste alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders meddra9.0 View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders meddra9.0 View
Urogenital disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders meddra9.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Hiccough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Rash desquamating NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders meddra9.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders meddra9.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View