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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT05117060
Description: None
Frequency Threshold: 5
Time Frame: Week 0 to Week 16+3 days
Study: NCT05117060
Study Brief: Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LEO 152020 - Dosing Regimen 2 (Middle Dose) Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - middle dose. Film coated tablets, administered orally. 0 None 2 45 24 45 View
LEO 152020 - Dosing Regimen 3 (Lower Dose) Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 and LEO 152020 placebo - lower dose. Film coated tablets, administered orally. 0 None 1 49 23 49 View
LEO 152020 - Dosing Regimen 1 (Higher Dose) Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 - higher dose. Film coated tablets, administered orally. 0 None 0 61 29 61 View
LEO 152020 - Placebo Subjects administered themselves daily for 16 weeks a fixed treatment of LEO 152020 placebo. Film coated tablets, administered orally. 0 None 0 61 24 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eczema herpeticum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Malignant melanoma in situ NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View