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 @ 4:45 PM
Ignite Modification Date: 2025-12-24 @ 4:45 PM
NCT ID: NCT04470050
Description: The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
Frequency Threshold: 5
Time Frame: 9 days
Study: NCT04470050
Study Brief: Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
60 Micrograms Sublingual film containing 60 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 17 5 17 View
90 Micrograms Sublingual film containing 90 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 21 2 21 View
120 Micrograms Sublingual film containing 120 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 19 4 19 View
180 Micrograms Sublingual film containing 180 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 21 8 21 View
240 Micrograms Sublingual film containing 180 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 15 9 15 View
Pooled Placebo Sublingual film containing Placebo Placebo: Sublingual Placebo film 0 None 0 25 5 25 View
30 Micrograms Sublingual film containing 30 Micrograms Dexmedetomidine Dexmedetomidine (BXCL501): Sublingual Film 0 None 0 17 1 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 23.0. View
Lacrimation Increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 23.0. View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.0. View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.0. View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.0. View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.0. View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 23.0. View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 23.0. View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 23.0. View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 23.0. View
Furnucle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 23.0. View
Blood Pressure Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 23.0. View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 23.0. View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 23.0. View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 23.0. View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 23.0. View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 23.0. View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 23.0. View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 23.0. View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 23.0. View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 23.0. View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 23.0. View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 23.0. View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 23.0. View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 23.0. View