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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT01383759
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01383759
Study Brief: Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Amyloidosis Participants with newly diagnosed AL amyloidosis 7 None 17 19 19 19 View
Monoclonal Ig DepositionDisease (MIDD) Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD) 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CPK increased SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Musculoskeletal & conn tissue disorder Other, spec SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Periorbital edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View