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 @ 4:55 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT03457818
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03457818
Study Brief: Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Placebo SC at Baseline and 6 months. Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits 0 None 1 4 1 4 View
Treatment Group Denosumab 60 mg/ml \[Prolia\] SC at baseline and 6 months. Denosumab 60 mg/ml \[Prolia\]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits 0 None 0 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vaginal yeast infection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View