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 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT00477750
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00477750
Study Brief: Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed 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
Treatment (Lenalidomide, Melphalan, Prednisone) Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression Intervention: Drug: melphalan 5mg/m\^2 orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression None None 7 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View