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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT03270956
Description: All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.
Frequency Threshold: 5
Time Frame: the day of biopsy through 24 months after the final injection of REACT, approximately 33 months
Study: NCT03270956
Study Brief: A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Renal Autologous Cell Therapy (REACT) Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available. Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC) 2 None 8 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal wall abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diabetic complication SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcapsular renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ESRD SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ESRD SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View