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 @ 4:13 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT02276066
Description: We report all adverse events for all individuals enrolled in this trial.
Frequency Threshold: 0
Time Frame: Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
Study: NCT02276066
Study Brief: Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Inhospital Group at Day 14 This group of sepsis participants will remain hospitalized at day 14. GFR assessment at inpatient day 14 and again at 1 year follow up 6 None 24 41 0 41 View
Discharged From Hospital Prior to Day 14 The group discharged before 14 days hospitalizaton. GFR assessment at discharge and again at 1 year follow-up 1 None 15 32 0 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
colostomy reversal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Readmission for wound care SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Readmission for pacemaker implant SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Readmission for planned angiogram SYSTEMATIC_ASSESSMENT Vascular disorders None View
Esophagael surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT General disorders None View
Altered Mental Status SYSTEMATIC_ASSESSMENT General disorders None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
cholecystectomy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pancreatic Surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
C. Diff infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood Transfusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):