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 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
NCT ID: NCT02489227
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02489227
Study Brief: Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Period 1: CHS-1420 CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15 0 None 4 274 41 274 View
Treatment Period 1: Humira (Adalimumab) Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15. 0 None 6 271 38 271 View
Treatment Period 2: CHS-1420/CHS-1420 At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 0 None 4 255 0 255 View
Treatment Period 2: Humira/CHS-1420 At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 0 None 3 126 0 126 View
Teatment Period 2: Humira/Humira At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 0 None 1 130 0 130 View
Treatment Period 3: Open Label CHS-1420 Extension At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end 1 None 4 474 0 474 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction None Cardiac disorders None View
Diarrhea None Gastrointestinal disorders None View
Gastroenteritis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Sinusitis None Infections and infestations None View
Foot Fracture None Injury, poisoning and procedural complications None View
Dehydration None Metabolism and nutrition disorders None View
Diabetic Ketoacidosis None Metabolism and nutrition disorders None View
Psoriatic arthropathy None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Chronic and obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Psoriasis None Skin and subcutaneous tissue disorders None View
Anal fistula None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Inguinal Hernia None Gastrointestinal disorders None View
Bronchitis None Infections and infestations None View
Lobar pneumonia None Infections and infestations None View
Tuberculosis None Infections and infestations None View
Limb injury None Injury, poisoning and procedural complications None View
Obesity None Metabolism and nutrition disorders None View
Congenital Cystic kidney disease None Congenital, familial and genetic disorders None View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Glioblastoma multiforme SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View