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 @ 5:26 PM
Ignite Modification Date: 2025-12-25 @ 3:00 PM
NCT ID: NCT06176768
Description: All randomized participants who received at least 1 dose of the study drug.
Frequency Threshold: 0
Time Frame: From baseline to the end of follow-up (up to Week 24)
Study: NCT06176768
Study Brief: A Study of LY3972406 in Adult Participants With Moderate-to-Severe 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
LY3972406 Participants received an oral dose of LY3972406 for 12 weeks. 0 None 0 16 9 16 View
Placebo Participants received an oral dose of placebo for 12 weeks. 0 None 1 17 6 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 28.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 28.0 View
Eczema eyelids SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 28.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 28.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Psoriatic arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Metastatic renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 28.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 28.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 28.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Nail ridging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 28.0 View