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 @ 4:20 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT00363766
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00363766
Study Brief: Study of LY573636-Sodium in Patients With Metastatic 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
LY573636 Target Cmax 380 µg/mL A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. None None 9 20 17 20 View
LY573636 Target Cmax 420 µg/mL A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. None None 17 32 30 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrointestinal Toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Condition Aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Bronchitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Radiation Pneumonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Alveolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Circulatory Collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypovolaemic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Superior Vena Caval Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Tooth Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Face Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Bronchitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Mouth Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Forced Expiratory Volume SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Neutrophil Count SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Testicular Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Bronchial Obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleuritic Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Peripheral Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Blood Potassium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View