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: 2025-12-25 @ 5:07 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT01301027
Description: Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
Frequency Threshold: 5
Time Frame: 26 Weeks
Study: NCT01301027
Study Brief: Effect of Adipokines in Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pioglitazone 15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks None None 11 48 16 48 View
Placebo 1 placebo pill a day matching the pioglitazone treatment for 26 weeks Placebo: 1 pill a day for 26 weeks None None 10 47 6 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Flu-like Syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Cardiac General - Volume Overload SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Colon Cancer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage - Lower GI NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Infection - Blood (Bacteremia) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal Pain NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chext/Thorax Pain NOS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Fistula failure SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Cardiac General - Volume Overload SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View