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 @ 2:10 PM
Ignite Modification Date: 2025-12-25 @ 12:50 PM
NCT ID: NCT00821795
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00821795
Study Brief: Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NPH/Regular 70/30 Mix transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration None None 15 50 6 50 View
Aspart Insulin Analog Biphasic Mix transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks None None 10 64 9 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiovascular disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebral vascular disease None Vascular disorders None View
Gastrointestinal None Gastrointestinal disorders None View
Genitourinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurological disease NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Adverse reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Severe Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View