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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT05855967
Description: All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
Frequency Threshold: 0
Time Frame: Week 0 up to 36 Weeks
Study: NCT05855967
Study Brief: A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Q2W/Q4W Ixekizumab Dosing Regimen Participants from PsO with no active PsA arm and active PsA arm with moderate to severe plaque psoriasis (PsO) received Q2W/Q4W Ixekizumab dosing regimen. 0 None 1 209 66 209 View
Q4W Ixekizumab Dosing Regimen Participants from Active PsA arm without moderate to severe PsO who received Q4W Ixekizumab dosing regimen. 0 None 0 41 9 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Hyperchlorhydria SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tinea cruris SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Typhoid fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View