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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT03055195
Description: Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Frequency Threshold: 3
Time Frame: On-treatment serious Adverse events (SAEs) and nSAEs were collected from the start of study treatment Up to 20 weeks
Study: NCT03055195
Study Brief: Efficacy and Safety Study of Mepolizumab in Subjects 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
Mepolizumab 100 mg SC Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. 0 None 0 19 1 19 View
Placebo SC Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. 0 None 0 15 7 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View