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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT03956550
Description: None
Frequency Threshold: 5
Time Frame: Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
Study: NCT03956550
Study Brief: A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to 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
Placebo Participants received matching placebo intravenously every 4 weeks (Q4W) 0 None 3 88 48 88 View
REGN5069 100 mg IV Q4W Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W) 0 None 3 85 33 85 View
REGN5069 1000 mg IV Q4W Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W) 0 None 0 84 36 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.1) View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.1) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View