Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT04304950
Description: Participants were monitored throughout the study and an adverse events log was kept. However, there are no major risks or discomforts associated with this study. The study procedures did not involve changing the medication or the dose of the medication the participants were taking. Participants only changed the time they took their medications ( morning or evening). Questionnaires and check-in calls were used to assess for any adverse events.
Frequency Threshold: 0
Time Frame: 1 year, 1 month
Study: NCT04304950
Study Brief: Chronotherapy in Inflammatory Bowel Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Evening Group Medication Administration Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol. Participants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol. Evening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm. 0 None 0 18 0 18 View
Morning Group Medication Administration Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol. Participants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol. Morning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am. 0 None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):