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: 2025-12-25 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT00646958
Description: While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
Frequency Threshold: 4
Time Frame: Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
Study: NCT00646958
Study Brief: Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radezolid QD 450 mg by mouth (PO) once daily (QD) None None 0 49 20 49 View
Radezolid BID 450 mg by mouth (PO) twice daily (BID) None None 0 50 17 50 View
Linezolid BID 600 mg by mouth (PO) BID None None 0 47 10 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal LFT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Infections and infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Investigations NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Elevated AST NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View