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: 2025-12-26 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
NCT ID: NCT01380106
Description: None
Frequency Threshold: 5
Time Frame: Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.
Study: NCT01380106
Study Brief: Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed 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
Lenalidomide 25mg Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle 1 None 12 16 0 16 View
Lenalidomide 15mg Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle. 0 None 10 17 0 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DVT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Loss of consciousness SYSTEMATIC_ASSESSMENT General disorders None View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rectal adenocarcinoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Potassium level change SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alpha strep infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercapnic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Coronary ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased urination SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low calcium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GERD (suspected) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastric Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Altered mental state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):