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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT03800420
Description: TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03800420
Study Brief: Efficacy and Safety of BBT-401-1S in 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
BBT-401-1S BBT-401-1S, Oral capsule, QD BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks. 0 None 0 12 8 12 View
Placebo Placebo, Oral capsule, QD Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks. 0 None 0 4 1 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Onychomycosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Faecal calprotectin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Stool analysis abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal tract mucosal pigmentation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View