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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01950169
Description: Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.
Frequency Threshold: 0
Time Frame: Adverse event data were collected 1 year for every patient included.
Study: NCT01950169
Study Brief: Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
B, Bisphosphonate Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. 1 None 0 28 2 28 View
BN/N, Bisphosphonate Along With Nutritional Supplementation Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily). 0 None 0 26 0 26 View
C, Control The patients were randomized to receive calcium and vitamin D3 alone and served as controls. 0 None 0 25 3 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation/diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View