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 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:58 PM
NCT ID: NCT00093756
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00093756
Study Brief: Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for 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
PhaseI PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV. None None 9 21 21 21 View
PhaseII PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV. None None 12 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophageal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Paranasal sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Laryngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngeal examination abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View