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: NCT00577395
Description: Specific safety parameters and procedures were to include vital signs, serum chemistry panel/hematology/urinalysis, and recording of AEs, including moderate-to-severe upper GI events and clinical fractures.
Frequency Threshold: 1
Time Frame: From the point of study enrolment until the subject's last observation.
Study: NCT00577395
Study Brief: Bone Microarchitecture in Osteopenic Postmenopausal Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
One 150 mg Risedronate Once a Month one 150 mg risedronate once a month, orally None None 0 7 2 7 View
Placebo Tablet Once a Month Placebo tablet once a month, orally None None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Abdominal distension View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT General disorders Pharyngitis View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Blood pressure incre View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Ear infection View