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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT00570960
Description: None
Frequency Threshold: 5
Time Frame: Within 30 days of study drug administration.
Study: NCT00570960
Study Brief: Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dextran Therapy Arm antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three None None 0 4 4 4 View
Standard of Care Albumin Arm antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three None None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hepatic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Clostridium difficle colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Excess ascites recurrence SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View