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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT03093402
Description: National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Frequency Threshold: 5
Time Frame: AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
Study: NCT03093402
Study Brief: JBT-101 in 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
High: JBT-101 20mg/20mg Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84. 0 None 1 25 10 25 View
Medium: JBT-101 20mg/Placebo Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84. 0 None 3 27 11 27 View
Low: JBT-101 5mg/5mg Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84. 0 None 0 24 16 24 View
Placebo Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84. 0 None 2 25 17 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Enterocolitis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 23.0 View
Serositis SYSTEMATIC_ASSESSMENT General disorders 23.0 View
Herpes simplex meningitis SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 23.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Systemic lupus erythematosus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 23.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 23.0 View