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 @ 4:42 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT05640466
Description: None
Frequency Threshold: 0
Time Frame: 4 months postoperative
Study: NCT05640466
Study Brief: Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adult Patient With Displaced Metatarsal Head Fractures A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier. Subsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire. Reduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique 0 None 1 20 0 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
stifness foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 20 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bone infection SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 20 View