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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT00374803
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00374803
Study Brief: Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mycophenolic Acid Loading Group Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter None None 4 22 17 22 View
Mycophenolic Acid No Load Group Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day) None None 14 23 15 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Acute Tubular Necrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Acute Kidney Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hemorrhoidal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Worsening Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Gout NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Dehiscence with evisceration NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Coronary Artery Bypass NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Altered Mental Status NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Post-transplant lymphoproliferative disorder (PTLD) NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
CMV Viremia NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View