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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT02207556
Description: Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02207556
Study Brief: Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxycycline (Localized Disease) Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use. 0 None 1 5 5 5 View
Doxycycline (Systemic Disease) Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use. 5 None 13 25 24 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphocyte production decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.03 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.03 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.03 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.03 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.03 View
Adenovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Progressive cardiac amyloidosis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Death in Hospice SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED View
Natural Death SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED View
Thrombosis of Vein of Lower Limb SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v4.03 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v4.03 View
Bacterial Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Drug-Induced Lupus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Noncardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.03 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Edema, Limb SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.03 View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.03 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.03 View
Bullous Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Cardiac Tropinin T Increased SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Hearing Impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v4.03 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Laryngeal Hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Low Vitamin D SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.03 View
Lung Crackles SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Rhinitis Infective SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Rib Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Streptococcal Test, Positive SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Sunburn (Burn) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Urine Output Decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
White Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Neutrophil Cound Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
AST Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
ALT Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.03 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.03 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.03 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.03 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Generalized Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Hyopohosphatemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Sore Throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Left Atrium Enlarged SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.03 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Blurred Vison SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Chest Pain - Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.03 View
Gait Disturbance, Unsteady SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Irregular Heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Jugular Vein Distention SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.03 View
Macroglossia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Mucocitis, Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Periorbital Edema/Puffiness SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Right Atrium Enlarged SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Chest Tightness SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Cyanosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.03 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Edema, Tongue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.03 View
Erythematous Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Eye Discharge SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.03 View
Flushiing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.03 View
Hypernatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.03 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.03 View
Inguinal Hernia Repair SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Injury to Lip SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Murmur, Systolic II/IV SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Night Sweats SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4.03 View
Petichial Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.03 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.03 View
Skin Tear SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.03 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.03 View
Ulceration, Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.03 View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Urinary Tract Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.03 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v4.03 View
Watering Eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.03 View