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 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT04179032
Description: The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
Frequency Threshold: 2
Time Frame: Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
Study: NCT04179032
Study Brief: Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belimumab 200 mg Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks. 0 None 1 25 19 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View
Urine protein/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.1 View