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 @ 12:10 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT01593761
Description: None
Frequency Threshold: 0
Time Frame: Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Study: NCT01593761
Study Brief: Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subjects Received CG400549, MITT All enrolled subjects who received any amount of study drug and was equivalent to the safety population. None None 0 20 13 20 View
Subjects Proven MRSA, mMITT The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA None None 0 11 10 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 15.0 View
lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 15.0 View
tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.0 View
cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
injection site cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
urinary track infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.0 View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.0 View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.0 View
injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.0 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.0 View
ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Road Traffic Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.0 View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.0 View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 15.0 View