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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT01205503
Description: None
Frequency Threshold: 0
Time Frame: All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
Study: NCT01205503
Study Brief: Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Saline Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization Infused over 15 minutes None None 1 32 30 32 View
Mesna Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes None None 1 32 29 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
MRSA positive infection in toe NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Bullous Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Esophageal Spasms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fibrinogen decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Flank Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lip Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle weakness upper limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tooth Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary Frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View