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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT05044234
Description: TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Frequency Threshold: 5
Time Frame: All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively.
Study: NCT05044234
Study Brief: A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe 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
Placebo Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. 0 None 0 39 8 39 View
75 mg Cedirogant Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. 0 None 0 39 4 39 View
375 mg Cedirogant Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. 0 None 2 39 16 39 View
150 mg Cedirogant Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. 0 None 1 39 9 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CERVICAL VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
LUMBAR SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
ELECTROCARDIOGRAM QT PROLONGED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
PSORIASIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View