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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT01089569
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
Study: NCT01089569
Study Brief: Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exenatide 5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study Exenatide: refer to Arm detail None None 0 20 20 20 View
Insulin Glargine .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results Insulin Glargine: refer to Arm detail None None 0 20 10 20 View
Exenatide + Insulin Glargine Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study \+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results None None 0 20 13 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View