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 @ 6:55 PM
Ignite Modification Date: 2025-12-25 @ 4:28 PM
NCT ID: NCT02304757
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected at 1year.
Study: NCT02304757
Study Brief: 99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
99Tc-MDP 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m. 99Tc-MDP: 99Tc-MDP, H20000218 0 None 0 70 0 70 View
Fosamax 70mg po every week for 12 months. Alendronate Sodium: H20080172 0 None 0 72 6 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper gastrointestinal (GI) adverse events SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View