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 @ 4:20 AM
Ignite Modification Date: 2025-12-26 @ 3:21 AM
NCT ID: NCT01073020
Description: Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT01073020
Study Brief: Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Laparoscopic Adjustable Gastric Band Surgery Surgical Implantation of Allergan Adjustable Gastric Band (Device) 0 None 9 18 0 18 View
Intensive Medical Diabetes and Weight Management: Band Group None 1 None 6 22 0 22 View
Roux-en-Y Gastric Bypass (RYGB) Surgery None 0 None 11 19 0 19 View
Intensive Medical Diabetes and Weight Management: RYGB Group None 0 None 5 19 0 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
sudden death SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
hospitalization for diabetes management SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
coronary bypass graft or stent SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
cardiac arrest - survived SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
presyncope SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
syringomyelia repair SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
bariatric surgery revisions and complications SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
orthopedic procedures SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
congestive heart failure hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
supraventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
pulmonary embolism SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
psychiatric hospitalizations SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
panniculectomy SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Erb's palsy SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Other Events(If Any):