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 @ 5:48 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT04814368
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 52 weeks.
Study: NCT04814368
Study Brief: A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (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
ACZ885 600 mg ACZ885 600 mg single dose intra-articular. 0 None 0 8 4 8 View
Total Total 0 None 0 23 8 23 View
Placebo to ACZ885+LNA043 40 mg Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times. 0 None 0 3 1 3 View
Placebo to ACZ885 Placebo to ACZ885 single dose intra-articular. 0 None 0 9 2 9 View
ACZ885 600 mg + LNA043 40 mg ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times. 0 None 0 3 1 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (27.1) View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (27.1) View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (27.1) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (27.1) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.1) View