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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT00612534
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00612534
Study Brief: A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo NanoTab None None None 1 24 8 24 View
Sufentanil NanoTab 5 Mcg None None None 0 24 13 24 View
Sufentanil NanoTab 10 Mcg None None None 1 26 12 26 View
Sufentanil NanoTab 15 Mcg None None None 1 20 10 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
respiratory depression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
white blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
oral mucosal discoloration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations None View
lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypoventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View