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: 2025-12-25 @ 4:47 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT02452918
Description: Safety analysis population included all participants who were dosed with IV oritavancin.
Frequency Threshold: 5
Time Frame: Up to 2 weeks after first administration of oritavancin
Study: NCT02452918
Study Brief: A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oritavancin 1200 mg Without Concomitant Warfarin Therapy Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy 0 None 0 15 2 15 View
Oritavancin 1200 mg With Concomitant Warfarin Therapy Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion site phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Subcutaneous hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View