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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT04493151
Description: Adverse event - any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug, whether or not considered drug related: MILD - present, but easily tolerated MODERATE - discomfort that interferes with usual activities SEVERE - incapacitating, inability to work or do usual activities
Frequency Threshold: 0
Time Frame: Adverse events were collected over a 48 hour window, from the first imipenem-relebactam dose (0 hour) to the end of blood sampling (6 hours), plus an 24 hour observation window after the last sample was collected, culminating with physical exam. Note: 8 subjects were enrolled and received imipenem-relebactam. Although only 7 subjects were included in results analysis due to inability to obtain blood samples in 1 subject, all 8 subjects are included in the adverse event reporting.
Study: NCT04493151
Study Brief: Imipenem/Cilastatin/Relebactam PK in ECMO
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Imipenem-Cilastatin-Relebactam Participants will receive a four to six doses of intravenous imipenem-cilastatin-relebactam as per current prescribing information based on estimated creatinine clearance. Imipenem, Cilastatin and Relebactam: After receipt of imipenem-cilastatin-relebactam, ten blood samples will be collected to determine the pharmacokinetics of imipenem and relebactam. 0 None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increasing Leukocytosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate Aminotransferase Increase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alkaline Phosphate Increase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
C. difficile Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View