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: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT02056834
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Study: NCT02056834
Study Brief: chronOS Inject in Proximal Tibial Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
chronOS Inject Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures None None 1 36 9 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-union of lateral tibial condyle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
K-wire irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Volar mass on finger (MP joint) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Articular subsidence, loss of reduction and depression of lateral condyle of the tibia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cartilage damage at the initial injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Posterior neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-union of lateral tibial condyle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View