Adverse Events Module

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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT02119468
Description: None
Frequency Threshold: 0
Time Frame: From the date of the first dose up to 2 years
Study: NCT02119468
Study Brief: Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Level #1 (3mg MLN9708) Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally 4 None 4 7 7 7 View
Dose Level #2 (4mg MLN9708) Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally 6 None 11 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Buttock pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Reproductive system and breast disorders - Other, specify SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Paroxysmal atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Tricuspid valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View