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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT00003869
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00003869
Study Brief: Carboxyamidotriazole in Treating Patients With Stage III or Stage IV 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
Carboxyamidotriazole 250 mg carboxyamidotriazole administered daily None None 9 90 87 90 View
Placebo 250 mg placebo administered daily None None 6 92 84 92 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Ischemia/Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Pain-Abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fever-No ANC SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 5 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuro-Sensory SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Adult respiratory distress syndrome (ARDS) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Effusion-Pleural SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Auditory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Inner Ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Vision-Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Vision-Double SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Vision-Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Diarrhea-BMT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Diarrhea-No Colostom SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dysphagia-esophageal related to radiation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Hematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Mouth Dryness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Pain-Abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fever-No ANC SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Pain-Chest SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Rigors SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Bilirubin SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Leukopenia-Peds SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Metabolic/Lab SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Prothrombin Time SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
SGOT (AST) (serum glutamic oxaloacetic transaminase) SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
SGPT (ALT) (serum glutamic pyruvic transaminase) SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Pain-Bone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Pain-Tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 5 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
CNS hemorrhage/bleeding SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Learning Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Low Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Memory Loss SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuro-Motor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuro-Sensory SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Smell SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Taste SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pain-Pleuritic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Voice Change SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Blood/Bone Marrow SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Arrhythmia-Nodal SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View