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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT02954159
Description: None
Frequency Threshold: 0
Time Frame: 20 months, 13 days
Study: NCT02954159
Study Brief: Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Arm vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily) Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently. Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care. 0 None 1 2 2 2 View
Placebo Arm vedolizumab at standard regimen with placebo. Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care. Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm. 0 None 0 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Increase in severity of UC symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intermittent tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
clinically significant elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
clinically significant low magnesium SYSTEMATIC_ASSESSMENT Endocrine disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increased diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increase in severity of UC symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increased pain SYSTEMATIC_ASSESSMENT General disorders None View
clinically significant low phosphorus SYSTEMATIC_ASSESSMENT Endocrine disorders None View