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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT01095250
Description: One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
Frequency Threshold: 0.0
Time Frame: None
Study: NCT01095250
Study Brief: Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AIN457 300mg Every 2 Weeks AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks None None 1 8 6 8 View
AIN457 300mg Every 4 Weeks AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks. None None 1 10 4 10 View
AIN457 150mg Every 4 Weeks AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks None None 0 8 6 8 View
Placebo Every 2 Weeks Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks None None 0 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cataract traumatic (Fellow eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye injury (Fellow eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased (Fellow eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dementia Alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Intentional self-injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Blepharitis (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blepharitis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract nuclear (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract nuclear (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular sarcoidosis (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular sarcoidosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View