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 @ 12:16 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT02579161
Description: The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
Frequency Threshold: 2
Time Frame: All adverse events occurring within the first 30 post-operative days were recorded for each patient.
Study: NCT02579161
Study Brief: Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Antibiotics for a 24 Hour Period Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones 0 None 1 49 9 49 View
Continued Antibiotics Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones 0 None 2 49 10 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemothorax/Pneumothorax SYSTEMATIC_ASSESSMENT Surgical and medical procedures Clavien-Dindo View
Fevers with Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders Clavien-Dindo View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fevers post operative SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Clavien-Dindo II View
Post operative urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders Clavien-Dindo I View
Post operative pain SYSTEMATIC_ASSESSMENT General disorders Clavien-Dindo I View
Post operative anemia requiring transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures Clavien-Dindo I View
Post-operative embolization SYSTEMATIC_ASSESSMENT Surgical and medical procedures Clavien-Dindo IIIa View