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 @ 9:38 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT02654132
Description: All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Frequency Threshold: 5
Time Frame: All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)
Study: NCT02654132
Study Brief: An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
E-Pd Cohort Elotuzumab + Pomalidomide + Dexamethasone 41 None 42 60 56 60 View
Pd Cohort Pomalidomide + Dexamethasone 41 None 33 55 49 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Primary amyloidosis SYSTEMATIC_ASSESSMENT Immune system disorders 24.1 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
H1N1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Progressive multifocal leukoencephalopathy SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Systemic infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Invasive breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Plasma cell leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Prostate cancer stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Haemorrhagic transformation stroke SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Bladder prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View