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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT01967433
Description: Hypoxia (defined as O 2 saturation less than 89% lasting for more than 30 seconds), hypertension (20 mm Hg increase in blood pressure from baseline, provided this is \>140 mm Hg systolic and 90 mm Hg diastolic), hypotension (20 mmHg decrease in blood pressure from baseline, provided this is \<100 mm Hg systolic or 60 mm Hg diastolic), bradycardia (a decrease in heart rate of \>20 bpm, provided this is less than 60), tachycardia (an increase in heart rate of \>20 bpm, provided this \>100 bpm)
Frequency Threshold: 0
Time Frame: Preprocedure, procedural, post procedure and 24 hr follow up
Study: NCT01967433
Study Brief: Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
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 0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives 0 None 0 58 25 58 View
Diphenhydramine Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives 0 None 0 61 17 61 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Reversal Agent SYSTEMATIC_ASSESSMENT General disorders None View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View