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 @ 1:00 AM
Ignite Modification Date: 2025-12-25 @ 11:13 PM
NCT ID: NCT04596293
Description: The safety population included all subjects who receive at least 1 dose of study drug. Subjects are categorized in the treatment group of the treatment they actually receive.
Frequency Threshold: 5
Time Frame: From ICF consent up to 16 weeks for those who had completed the study or discontinued early
Study: NCT04596293
Study Brief: Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo/Induction Phase Participants who received placebo in induction phase for 8 weeks 0 None 0 13 1 13 View
BBT-401-1S 800mg/Induction Phase Participants who received BBT-401-1S 800mg in induction phase for 8 weeks 0 None 1 12 3 12 View
BBT-401-1S 1600mg/Induction Phase Participants who received BBT-401-1S 1600mg in induction phase for 8 weeks 0 None 0 13 1 13 View
Placebo/Extension Phase Participants who received placebo in extension phase for 8 weeks 0 None 0 6 1 6 View
BBT-401-1S 800mg/ Extension Phase Participants who received BBT-401-1S 800mg in extension phase for 8 weeks 0 None 0 8 2 8 View
BBT-401-1S 1600mg/ Extension Phase Participants who received BBT-401-1S 1600mg in extension phase for 8 weeks 0 None 0 17 4 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bartholin's cyst removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Abscess drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Coagulation factor decreased SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Peritonsillar abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View