Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:06 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT01177735
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01177735
Study Brief: Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk 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
Pomalidomide Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity. None None 6 71 71 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute renal failure None Renal and urinary disorders None View
Hospitalization for sinus infection None Infections and infestations None View
Hospialization for progressive disease, sepsis and pneumonia None Infections and infestations None View
Hospitalization for removal of port None Injury, poisoning and procedural complications None View
Hospitalization for fever None Infections and infestations None View
RSV Pneumonia None Infections and infestations None View
Fever neutropenia dehydration None Infections and infestations None View
Hospitalization for neutropenic fever None Infections and infestations None View
Hospitalization due to acute liver failure hepatitis B flare None Infections and infestations None View
Hospitalization for pneumonia None Infections and infestations None View
Atrial Fibrilation None Cardiac disorders None View
Pancytopenia None Blood and lymphatic system disorders None View
Hypoxia None General disorders None View
Hospitalization dyspnea due to congestive heart failure None Cardiac disorders None View
Hospitalization for shortness of breath None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Dyspnea on exertion None Cardiac disorders None View
Hospitalization for bronchitis None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Blood and lymphatic system disorders None View
Hospitalization for hypotension None Cardiac disorders None View
Respiratory failure secondary to opioid overdose None Respiratory, thoracic and mediastinal disorders None View
Hospitalization for intractable pain, low fever None Nervous system disorders None View
Hospitalization for acute respiratory distress syndrome, encephalopathy, fatigue None Nervous system disorders None View
Pneumonia None Infections and infestations None View
Intrahepatic chemotherapy None Surgical and medical procedures None View
Paraparesis, spinal cord compression None Nervous system disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Fracture of T7 with possible cord compression None Injury, poisoning and procedural complications None View
Deep vein thrombosis and cerebrovascular accident None Cardiac disorders None View
Blood transfusion None Blood and lymphatic system disorders None View
Wrong dosage dispensed None Surgical and medical procedures None View
Hospitalization with fever and low blood pressure None Cardiac disorders None View
Acute diarrhea None Gastrointestinal disorders None View
Hospitalization for Pneumonia and gastrointestinal bleeding None Gastrointestinal disorders None View
Hospitalization for diarrhea and dizziness None Gastrointestinal disorders None View
Elevated liver function test None Infections and infestations None View
Deep vein thrombosis diagnosis None Vascular disorders None View
Hospitalization for sepsis None Infections and infestations None View
Worsening renal failure None Renal and urinary disorders None View
Tachycardia None Cardiac disorders None View
Pneumonia, fever and altered mental status None Infections and infestations None View
Severe cough, shortness of breath and hypoxemia None Respiratory, thoracic and mediastinal disorders None View
Shortness of breath fever chills None Respiratory, thoracic and mediastinal disorders None View
Hospitalization for parainfluenza type 2 None Infections and infestations None View
Mental status changes and bacteremia None Psychiatric disorders None View
Recurrent multifocal pneumonia None Infections and infestations None View
Upper respiratory infection and fever None Respiratory, thoracic and mediastinal disorders None View
Acute onset diarrhea and acute renal insufficiency None Infections and infestations None View
Hospitalization due to transient ischemic attack None Vascular disorders None View
Shortness of breath with wheezing None Respiratory, thoracic and mediastinal disorders None View
Recurrent bilateral pneumonia None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood/Bone Marrow SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac General SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constitutional Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Dermatology / Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage / Bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hepatobiliary / Pancreas SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphatics SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic/Laboratory SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal / Soft Tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurology SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ocular / Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary / Upper Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal / Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View