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 @ 10:04 PM
Ignite Modification Date: 2025-12-25 @ 7:40 PM
NCT ID: NCT05283135
Description: AEs were collected from the time of consent at all subject visits
Frequency Threshold: 0
Time Frame: 100 weeks
Study: NCT05283135
Study Brief: High Dose Risankizumab for 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
600 mg Dose Group Received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period. 0 None 0 10 7 10 View
300 mg Dose Group Received risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period. 0 None 1 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
worsening right tibial fracture and meniscal tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Common cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczematous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Bleeding internal hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bursitis, left elbow SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening psoriatic arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Osteoarthritis, right hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening osteoarthritis, right hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis, left lower extremity SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right tibial fracture and meniscal tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left inguinal hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View