Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:35 PM
Ignite Modification Date: 2025-12-25 @ 1:07 PM
NCT ID: NCT01265459
Description: None
Frequency Threshold: 5
Time Frame: Adverse events data were collected during 26 weeks.
Study: NCT01265459
Study Brief: Different Volumes of Durolane in Knee OA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Durolane 3 mL Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) None None 0 23 8 23 View
Durolane 4.5 mL Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) None None 2 23 12 23 View
Durolane 6 mL Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) None None 1 22 14 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary thrombosis None Vascular disorders MedDRA 13.1 View
Headache and high fever None General disorders MedDRA 13.1 View
Rectal prolaps None Surgical and medical procedures MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Headache None Nervous system disorders MedDRA 13.1 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Nasopharyngitis None Infections and infestations MedDRA 13.1 View
Gastroenteritis None Infections and infestations MedDRA 13.1 View