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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:51 PM
NCT ID: NCT02087150
Description: AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Frequency Threshold: 0
Time Frame: Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment
Study: NCT02087150
Study Brief: Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lead-In Subjects enrolled in the Lead-in group and treated with the ETBC 0 None 2 80 30 80 View
Randomized ETBC Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM) 1 None 5 149 58 149 View
Crossover MM Subjects enrolled and randomized to treatment with Medical Management (MM) only who crossed over to have treatment with the ETBC after the 6-week follow-up visit 0 None 0 70 20 70 View
ALL ETBC All subjects in the lead-in phase, subjects randomized to the investigational arm who received treatment with the ETBC, and subjects in the control arm who crossed over to have treatment with the ETBC 1 None 7 299 108 299 View
Randomized MM Subjects enrolled and randomized to treatment with Medical Management (MM) only 0 None 1 80 18 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular accident None Nervous system disorders None View
Syncope None Nervous system disorders None View
Bipolar I disorder None Psychiatric disorders None View
Pneumothorax None Respiratory, thoracic and mediastinal disorders None View
Coronary artery occlusion None Cardiac disorders None View
Non-cardiac chest pain None General disorders None View
Pelvic fracture None Injury, poisoning and procedural complications None View
Myocardial infarction None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coronary artery disease None Cardiac disorders None View
Conductive deafness None Ear and labyrinth disorders None View
Deafness None Ear and labyrinth disorders None View
Ear discomfort None Ear and labyrinth disorders None View
Ear pain None Ear and labyrinth disorders None View
Eustachian tube disorder None Ear and labyrinth disorders None View
Eustachian tube dysfunction None Ear and labyrinth disorders None View
Eustachian tube obstruction None Ear and labyrinth disorders None View
Eustachian tube patulous None Ear and labyrinth disorders None View
Hypoacusis None Ear and labyrinth disorders None View
Middle ear effusion None Ear and labyrinth disorders None View
Otorrhea None Ear and labyrinth disorders None View
Tinnitus None Ear and labyrinth disorders None View
Tympanic membrane perforation None Ear and labyrinth disorders None View
Vertigo None Ear and labyrinth disorders None View
Tympanic membrane disorder None Ear and labyrinth disorders None View
Oesophageal spasm None Gastrointestinal disorders None View
Tooth impacted None Gastrointestinal disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Glossodynia None Gastrointestinal disorders None View
Inguinal hernia None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Adverse drug reaction None General disorders None View
Effusion None General disorders None View
Facial pain None General disorders None View
Oedema None General disorders None View
Pyrexia None General disorders None View
Sensation of foreign body None General disorders None View
Herpes zoster None Infections and infestations None View
tooth abscess None Infections and infestations None View
Viral upper respiratory tract infection None Infections and infestations None View
Acute sinusitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Cellulitis None Infections and infestations None View
Chronic sinusitis None Infections and infestations None View
Conjunctivitis infective None Infections and infestations None View
Ear infection None Infections and infestations None View
Hordeolum None Infections and infestations None View
Infection None Infections and infestations None View
Influenza None Infections and infestations None View
Myringitis bullous None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Otitis extrerna None Infections and infestations None View
Otitis media None Infections and infestations None View
Otitis media acute None Infections and infestations None View
Otitis media chronic None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Pharyngitis streptococcal None Infections and infestations None View
Pneumonia None Infections and infestations None View
Sinusitis None Infections and infestations None View
Tonsillitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Deafness traumatic None Injury, poisoning and procedural complications None View
Joint injury None Injury, poisoning and procedural complications None View
Laceration None Injury, poisoning and procedural complications None View
Ligament sprain None Injury, poisoning and procedural complications None View
Mucosal excoriation None Injury, poisoning and procedural complications None View
Tibia fracture None Injury, poisoning and procedural complications None View
Blood potassium decreased None Investigations None View
Type 2 diabetes mellitus None Metabolism and nutrition disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Pain in jaw None Musculoskeletal and connective tissue disorders None View
Periarthritis None Musculoskeletal and connective tissue disorders None View
Syncope None Nervous system disorders None View
Sinus congestion None Respiratory, thoracic and mediastinal disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Nasal polyps None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Reflux laryngitis None Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders None View
Wheezing None Respiratory, thoracic and mediastinal disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Pruritis None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Cholesteatoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Hypoaesthesia None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Sinus headache None Nervous system disorders None View