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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT01246895
Description: The incidence of AEs, SAEs, and incidents have been summarized by SOC and preferred terms according to MedDRA preferred terminology for each treatment group, frequency, maximum severity, and relationship to procedure or device.
Frequency Threshold: 0
Time Frame: Adverse events collected from signature of ICF (follow-up study) to 5 year follow-up.
Study: NCT01246895
Study Brief: Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Microfracture + BST-CarGel Microfracture with BST-CarGel 0 None 0 37 2 37 View
Microfracture Alone Microfracture without BST-CarGel 0 None 1 30 3 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LEFT KNEE THROBBING PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
LEFT KNEE MEDIAL CLICKING THAT INITIATES THROBBING SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
PAIN LEFT KNEE/ ABOVE KNEE CAP SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
FEELING OF RIGHT KNEE GIVING OUT SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
RIGHT KNEE PAIN AFTER EXERCISE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
MIGRAINES SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View