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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT04120402
Description: None
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) were summarized and analyzed for safety evaluations i.e, events which occurred from the time of the EP-104IAR or vehicle injection procedure until the Week 24/End-of-Study/Early Exit Visit.
Study: NCT04120402
Study Brief: Study to Evaluate the Efficacy and Safety of EP-104IAR 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
EP-104IAR 25 mg A single use intra-articular injection containing 25 mg of EP-104IAR EP-104IAR 25 mg: Single 5 mL intra-articular injection 0 None 4 163 76 163 View
Placebo (Vehicle) A single use intra-articular injection containing no active ingredients Vehicle: Single 5 mL intra-articular injection 0 None 1 155 68 155 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.0) View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (24.0) View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (24.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.0) View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View