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 @ 2:53 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT05069259
Description: Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).
Frequency Threshold: 0
Time Frame: Maximum up to 20 weeks
Study: NCT05069259
Study Brief: Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included. 0 None 1 18 4 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening Ulcerative Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsening Ulcerative Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE5.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE5.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE5.0 View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE5.0 View