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 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02049866
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Study: NCT02049866
Study Brief: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Denosumab Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months 0 None 0 33 26 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Redness SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness and/or tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in thighs, hips, or groin SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Energy SYSTEMATIC_ASSESSMENT General disorders None View