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 @ 12:30 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT01487161
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from post injection on Day 1 through Day 85
Study: NCT01487161
Study Brief: Study of FX006 in Patients With Osteoarthritis 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
FX006 10 mg FX006: Single 3 mL IA injection 0 None 0 58 13 58 View
FX006 40 mg FX006: Single 3 mL IA injection 0 None 2 59 16 59 View
FX006 60 mg FX006: Single 3 mL IA injection 0 None 1 60 22 60 View
TCA IR (40 mg) TCA IR: Single 1 mL IA injection 0 None 0 51 22 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngits SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White Blood Cell Count Inreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View