Study of Safety and Efficacy for the Eustachian Tube Ball... | NCT02087150

Name	Class
Acclarent	INDUSTRY

Label	Type	Description	Intervention Names
Medical management (MM)	No Intervention	Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube balloon catheter (ETBC) plus MM	Experimental	Eustachian tube dilation with the ETBC plus medical management	Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)

Name	Type	Description	Arm Group Labels	Other Names
Acclarent Eustachian Tube Balloon Catheter (ETBC)	Device		Eustachian tube balloon catheter (ETBC) plus MM

Measure	Description	Time Frame
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks	The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function	6 Week Follow-Up Visit

Measure	Description	Time Frame
Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks	The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.

Measure	Description	Time Frame
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks	Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Name	Affiliation	Role
Dennis Poe, MD, PhD	Boston Children's Hospital	Principal Investigator
Vijay Anand, MD	Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
California Ear Institute		East Palo Alto	California	94303	United States
George Washington Medical Faculty Associates, ENT Center

PubMed Identifier	Type	Citation	Retractions
40008607	Derived	Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

ID	Title	Description
FG000	Lead-In	Subjects enrolled in Lead-In Group
FG001	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)

ID	Title	Description
BG000	Lead-In	Subjects enrolled in Lead-In Group
BG001	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
BG002	Randomized MM	Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00081 BG001162 BG00280 BG003323

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks

The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function

Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).

Posted

Count of Participants

Participants

6 Week Follow-Up Visit

ID	Title	Description
OG000	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
OG001	Randomized MM	Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits

Units	Counts
Participants	OG000143 OG00172

Title

Denominators

Categories

Title	Measurements
	OG00073 OG00110

Secondary

Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks

The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.

Posted

Count of Participants

Participants

6 Week Follow-Up Visit

ID	Title	Description
OG000	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
OG001	Randomized MM	Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits

Other Pre-specified

Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks

Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)

Posted

Count of Participants

Participants

12, 24, 52 Week Follow-Up

ID	Title	Description
OG000	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
OG001	Randomized MM	Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits

Other Pre-specified

Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks

Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Posted

Count of Participants

Participants

12,24,52 Week Follow-Up Visit

ID	Title	Description
OG000	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
OG001	Randomized MM	Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits

Other Pre-specified

Exploratory Endpoint: WPAI at 6,12,24,52 Weeks

Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Posted

Mean

Standard Deviation

Percentage of Impairment

6,12,24,52 Week Follow-Up

ID	Title	Description
OG000	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)
OG001	Randomized MM

Other Adverse Events

Term	Organ System	Statistical Information
Coronary artery disease	Cardiac disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG0030 events0 affected299 at risk EG0041 events1 affected80 at risk
Conductive deafness	Ear and labyrinth disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Deafness	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0013 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Ear discomfort	Ear and labyrinth disorders	EG0003 events2 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Ear pain	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0014 events4 affected149 at risk EG0021 events1 affected70 at risk EG003
Eustachian tube disorder	Ear and labyrinth disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Eustachian tube dysfunction	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0014 events3 affected149 at risk EG0020 events0 affected70 at risk EG003
Eustachian tube obstruction	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Eustachian tube patulous	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Hypoacusis	Ear and labyrinth disorders	EG0001 events1 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0012 events2 affected149 at risk EG0022 events2 affected70 at risk EG003
Otorrhea	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Tinnitus	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0021 events1 affected70 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0014 events4 affected149 at risk EG0021 events1 affected70 at risk EG003
Vertigo	Ear and labyrinth disorders	EG0001 events1 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Tympanic membrane disorder	Ear and labyrinth disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0021 events1 affected70 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Tooth impacted	Gastrointestinal disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	EG0002 events2 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Glossodynia	Gastrointestinal disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Inguinal hernia	Gastrointestinal disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Toothache	Gastrointestinal disorders	EG0002 events2 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Vomiting	Gastrointestinal disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Adverse drug reaction	General disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Effusion	General disorders	EG0002 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Facial pain	General disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Oedema	General disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Pyrexia	General disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Sensation of foreign body	General disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Herpes zoster	Infections and infestations	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
tooth abscess	Infections and infestations	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Acute sinusitis	Infections and infestations	EG0003 events3 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Bronchitis	Infections and infestations	EG0001 events1 affected80 at risk EG0011 events1 affected149 at risk EG0022 events2 affected70 at risk EG003
Cellulitis	Infections and infestations	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Chronic sinusitis	Infections and infestations	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0021 events1 affected70 at risk EG003
Conjunctivitis infective	Infections and infestations	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Ear infection	Infections and infestations	EG0002 events1 affected80 at risk EG0011 events1 affected149 at risk EG0021 events1 affected70 at risk EG003
Hordeolum	Infections and infestations	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Infection	Infections and infestations	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Influenza	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Myringitis bullous	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Nasopharyngitis	Infections and infestations	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0024 events3 affected70 at risk EG003
Otitis extrerna	Infections and infestations	EG0001 events1 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Otitis media	Infections and infestations	EG0002 events1 affected80 at risk EG0014 events4 affected149 at risk EG0021 events1 affected70 at risk EG003
Otitis media acute	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Otitis media chronic	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pharyngitis	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pharyngitis streptococcal	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pneumonia	Infections and infestations	EG0002 events2 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Sinusitis	Infections and infestations	EG0004 events2 affected80 at risk EG0018 events7 affected149 at risk EG0024 events4 affected70 at risk EG003
Tonsillitis	Infections and infestations	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Upper respiratory tract infection	Infections and infestations	EG0006 events5 affected80 at risk EG00111 events10 affected149 at risk EG0026 events6 affected70 at risk EG003
Deafness traumatic	Injury, poisoning and procedural complications	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Joint injury	Injury, poisoning and procedural complications	EG0002 events2 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Laceration	Injury, poisoning and procedural complications	EG0001 events1 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Mucosal excoriation	Injury, poisoning and procedural complications	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Blood potassium decreased	Investigations	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	EG0001 events1 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Dizziness	Nervous system disorders	EG0002 events2 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Headache	Nervous system disorders	EG0000 events0 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Hypoaesthesia	Nervous system disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Paraesthesia	Nervous system disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Sinus headache	Nervous system disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Syncope	Nervous system disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0021 events1 affected70 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0013 events3 affected149 at risk EG0020 events0 affected70 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Rash	Skin and subcutaneous tissue disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lead-In	Subjects enrolled in the Lead-in group and treated with the ETBC	0	80	2	80	30	80
EG001	Randomized ETBC	Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	1	149	5	149	58	149
EG002	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	70	0	70	20	70
EG003	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	299	7	299	108	299
EG004	Randomized MM	Subjects enrolled and randomized to treatment with Medical Management (MM) only	0	80	1	80	18	80

Term	Organ System	Statistical Information
Coronary artery occlusion	Cardiac disorders	EG0000 events0 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG0030 events0 affected299 at risk EG0041 events1 affected80 at risk
Myocardial infarction	Cardiac disorders	EG0000 events0 affected80 at risk EG0012 events2 affected149 at risk EG0020 events0 affected70 at risk EG003
Non-cardiac chest pain	General disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Cerebrovascular accident	Nervous system disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Syncope	Nervous system disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003
Bipolar I disorder	Psychiatric disorders	EG0001 events1 affected80 at risk EG0010 events0 affected149 at risk EG0020 events0 affected70 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected80 at risk EG0011 events1 affected149 at risk EG0020 events0 affected70 at risk EG003