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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT01656967
Description: None
Frequency Threshold: 0
Time Frame: Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
Study: NCT01656967
Study Brief: AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AMBU Aura-I/aScope 2 First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system. AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera None None 0 29 3 29 View
LMA Fastrach The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube. LMA Fastrach Single Use None None 0 31 8 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hoarseness SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sore mouth SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sore neck SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sore Jaw SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dysphonia SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dysphagia SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Altered tongue sensation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View