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 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT02318134
Description: None
Frequency Threshold: 0
Time Frame: 10 months
Study: NCT02318134
Study Brief: Fecal Microbiota Transplantation for Pancreatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FMT Group In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. 3 None 24 30 25 30 View
Control Group In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. 4 None 24 30 25 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infected pancreatic necrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Persistent respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Persistent renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Persistent circulatory failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
gastrointestinal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intra-abdominal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrointestinal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrointestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infected ascites NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View