Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT00589056
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00589056
Study Brief: Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Nelfinavir cisplatin etoposide nelfinavir mesylate protein expression analysis immunohistochemistry staining method laboratory biomarker analysis biopsy radiation therapy 3 None 21 55 40 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Decreased ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diffuse Muscle Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection, Anal/perianal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, Lung (pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenic Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophils NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis/thrombus/embolism NON_SYSTEMATIC_ASSESSMENT Vascular 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
Chest Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other GI NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Giddiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperpigmentation in RT Field NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased Alk Phosphates NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased Creatinine NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
LLE DVT NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Left bundle branch block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mood Alteration NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
R Thoracic Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Salivary Gland Changes NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Severe headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shoulder Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Suprapubic Pain 2d UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tunnel Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
XRT Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Full extravasation - AC fossa NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis at hangnail NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholesterol NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Confusion / Forgetfulness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cramping NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dyspnea on exertion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased ALC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased Albumin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased Magnesium NON_SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased WBC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diaphoresis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty Swallowing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysuria None Renal and urinary disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear, nose and throat examination abnormal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Epigastrum NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Esophageal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Facial Erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Feet Tingling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hand Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hand Tremors NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hearing Loss NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Heart palpitations / A-fib / Chest pains NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heavy chest NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hiccough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoantremia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased ALT NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Increased DOE NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased Triglycerides NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infected L Eye NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intermittent Decreased Magnesium NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Irregular Menses NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Jaw Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
L Arm Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Left side burning sensation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leg Cramps NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Light headedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loose Stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
decreased total protein NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophils NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Night Sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nosebleed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Mucositis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Palmar Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pancytopemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngeal hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Poor bladder function NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rad Derm NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Radiation Dermatitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radiation recall reaction (dermatologic) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal Pain 2d Herpes NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
SOB NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin Rash / Dryness (XRT Derm) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Sensation - burning NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin in rad portal NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore R Cheek in Mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach cramping NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Swelling of Ankles NON_SYSTEMATIC_ASSESSMENT General disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Systolic Blood Pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia - A-fib NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Taste Alteration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Throat pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrush NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Voice Change NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WBC Decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AST Transaminase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkalosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Altered Taste NON_SYSTEMATIC_ASSESSMENT General disorders None View