## Protocol Section
### Identification Module
**NCT ID:** NCT00909779

**Brief Title:** Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

**Official Title:** A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

#### Organization Study ID Info
**ID:** 091-080
#### Organization
**Class:** INDUSTRY
**Full Name:** Sumitomo Pharma America, Inc.
### Status Module
#### Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-11-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-11-11

**Type:** ESTIMATED

**Results First Submit Date:** 2013-06-21

**Results First Submit QC Date:** 2013-09-12

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2013-09

#### Study First Post Date
**Date:** 2009-05-28
**Type:** ESTIMATED
**Study First Submit Date:** 2009-05-26
**Study First Submit QC Date:** 2009-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sumitomo Pharma America, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

**Detailed Description:** This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist \[LABA\] COPD standard of care treatments). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

**Keywords:**

- Chronic obstructive pulmonary disease (COPD)

- respiratory

- long-acting beta agonist (LABA)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 841

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

**Intervention Names:**

- Drug: Arformoterol

**Label:** Arformoterol 15 mcg twice daily

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo twice daily

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arformoterol 15 mcg twice daily

**Description:** Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year

**Name:** Arformoterol

**Other Names:**

- Brovana

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo twice daily

**Description:** Placebo inhalation solution, twice daily (BID) for a duration of one year.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.

**Measure:** Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).

**Time Frame:** 0-12 months

#### Secondary Outcomes

**Description:** A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).

**Measure:** The Incidence of Protocol Defined COPD Exacerbations.

**Time Frame:** 0-12 months

**Description:** Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.

**Measure:** The Incidence of All Cause Mortality

**Time Frame:** 0-12 months

**Description:** TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.

The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated.

**Measure:** The Incidence of Treatment Emergent AEs

**Time Frame:** 0-12 months

**Description:** The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.

**Measure:** SGRQ: Mean Change From Baseline in Total Score

**Time Frame:** Baseline and on treatment at months 3, 6 and 12 (or early termination)

**Description:** FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.

**Measure:** FEV1: Mean Change From Baseline

**Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)

**Description:** Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1.

**Measure:** Percent Predicted FEV1: Mean Change From Baseline

**Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)

**Description:** Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.

**Measure:** Forced Vital Capacity (FVC): Mean Change From Baseline

**Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)

**Description:** IC: the total amount of air that can be drawn into the lungs after normal expiration.

IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline.

**Measure:** Inspiratory Capacity (IC): Mean Change From Baseline

**Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject must give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
* Females considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal, which is defined as a complete cessation of menstruation for at least 1 year.
* Male and female subjects must be at least 40 years old at the time of consent.
* Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD.
* Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose).
* Subjects must have a FEV1 \>0.50 L at either Visit 1 or 2 (pre-dose).
* Subject's respiratory status must be clinically stable.
* Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1 or 2 (pre-dose).
* Subjects must have had at least 1 COPD exacerbation within the last year (defined as initiation or an increase in the dose of oral steroids or antibiotics for the treatment of COPD).
* Subjects must have a ≥15 pack-year smoking history and a baseline breathlessness severity grade of ≥2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 2.
* Female subjects ≤65 years of age must have a negative serum pregnancy test conducted at Visit 1 prior to randomization. Females of childbearing potential must be using an acceptable method of birth control.
* Subjects' overall health must be sufficiently stable to complete the study requirements based on the screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis), and vital signs (heart rate, respiratory rate, and blood pressure) that have been conducted within 30 days of Visit 2 (randomization). If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator judges the deviations to be not clinically significant.
* Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulse of 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at Screening Visit 1 must meet the criteria on the first day of dosing (Day 1) in order to be eligible for the study. Subjects with a medical condition which causes low blood pressure or low heart rate, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved.
* Subjects must be willing and able to complete all study questionnaires and logs reliably.
* Subjects must be willing and able to comply with study procedures and visit schedule.
* Subjects must have sufficient understanding of English to complete all questionnaires and logs.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Subjects with a history of asthma, with the exception of asthma diagnosed in childhood.
* Subjects with a blood eosinophil count \>5% of total white blood cell count.
* Subjects with a febrile illness within 3 days before Screening.
* Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer. Subjects with a history of malignancy who have been cancer free for 5 years or more may be enrolled.
* Subjects who are currently using disallowed medications or will be unable to complete the medication washout periods. Subjects taking a prohibited concurrent medication which requires a washout of \>30 days may be rescreened when the washout of the prohibited concurrent medication has been met.
* Subjects with life threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to screening.
* Subjects who have had a change in dose or type of any medications for COPD within 2 weeks prior to the screening visit. Subjects not on a stable dose of COPD medications may be rescreened after being on a stable dose for at least 14 days
* Subjects with a chest x ray taken ≤3 months prior to screening that suggests a diagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest x ray taken ≤3 months prior to screening, or if recent results are unavailable for review, a chest x ray must be performed prior to visit 2. Subjects with a medical condition that caused the abnormal finding, but, in the opinion of the Principal Investigator or designee the medical condition could resolve, may be rescreened when the condition is resolved
* Subjects with a positive urine drug test during screening.
* Subjects with a known history of alcohol abuse may be enrolled in the study if the subject's current alcohol use does not exceed more than 3 alcoholic beverages per day.
* Subjects whose schedule or travel prevents the completion of all required visits.
* Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when the condition is resolved.
* Subjects have participated in an investigational drug study and/or any COPD interventional trial within 30 days prior to screening or who are currently participating in another investigational drug study or COPD interventional trial.
* Subjects with a history of allergic reaction to the study medication or any components of the study medications.
* Subjects who are study site staff members or relatives of study site staff members directly involved in this study.
* Subjects with clinically significant cardiac, (Functional Class III and IV; Objective Class C and D by New York Heart Association \[NYHA\] Functional Classification),hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Jefferson Clinic

**State:** Alabama

**Zip:** 25233

**Location 2:**

**City:** Birmingham

**Country:** United States

**Facility:** Alabama Clinical Therapeutic, LLC

**State:** Alabama

**Zip:** 35235

**Location 3:**

**City:** Brimingham

**Country:** United States

**Facility:** Achieve Clinical Research

**State:** Alabama

**Zip:** 35209

**Location 4:**

**City:** Jasper

**Country:** United States

**Facility:** Jasper Summit Research, LLC

**State:** Alabama

**Zip:** 35501

**Location 5:**

**City:** Anaheim

**Country:** United States

**Facility:** Chest Critical Care Consultants

**State:** California

**Zip:** 92801

**Location 6:**

**City:** Fullerton

**Country:** United States

**Facility:** California Research Medical Group

**State:** California

**Zip:** 92835

**Location 7:**

**City:** Riverside

**Country:** United States

**Facility:** Integrated Research Group

**State:** California

**Zip:** 92506

**Location 8:**

**City:** Roseville

**Country:** United States

**Facility:** Quality Control Research Inc.

**State:** California

**Zip:** 95661

**Location 9:**

**City:** Sacramento

**Country:** United States

**Facility:** Sockolov and Sockolov APC

**State:** California

**Zip:** 95825

**Location 10:**

**City:** Sacremento

**Country:** United States

**Facility:** Centers for Clinical Trials of Sacremento

**State:** California

**Zip:** 95823

**Location 11:**

**City:** San Diego

**Country:** United States

**Facility:** Institute of HealthCare Assessment, Inc.

**State:** California

**Zip:** 92120

**Location 12:**

**City:** Denver

**Country:** United States

**Facility:** National Jewish Health

**State:** Colorado

**Zip:** 80206

**Location 13:**

**City:** Chiefland

**Country:** United States

**Facility:** Southeast Clinical Research

**State:** Florida

**Zip:** 32626

**Location 14:**

**City:** Clearwater

**Country:** United States

**Facility:** Tampa Bay Medical Research Inc.

**State:** Florida

**Zip:** 33761

**Location 15:**

**City:** Clearwater

**Country:** United States

**Facility:** Clinical Research of West Florida, Inc.

**State:** Florida

**Zip:** 33765

**Location 16:**

**City:** DeLand

**Country:** United States

**Facility:** Avail Clinical Research

**State:** Florida

**Zip:** 32720

**Location 17:**

**City:** Kissimmee

**Country:** United States

**Facility:** The Lung Clinic, P.A.

**State:** Florida

**Zip:** 34741

**Location 18:**

**City:** Orlando

**Country:** United States

**Facility:** DCT

**State:** Florida

**Zip:** 32806

**Location 19:**

**City:** Tampa

**Country:** United States

**Facility:** Clinical Research of West Florida

**State:** Florida

**Zip:** 33603

**Location 20:**

**City:** Canton

**Country:** United States

**State:** Georgia

**Zip:** 30114

**Location 21:**

**City:** Columbus

**Country:** United States

**Facility:** Southeast Regional Research Group

**State:** Georgia

**Zip:** 31904

**Location 22:**

**City:** Decatur

**Country:** United States

**Facility:** Atlanta Pharmaceutical Research

**State:** Georgia

**Zip:** 30033

**Location 23:**

**City:** Marietta

**Country:** United States

**Facility:** Wellstar Marietta Pulmonary Medicine

**State:** Georgia

**Zip:** 30060

**Location 24:**

**City:** Rincon

**Country:** United States

**Facility:** Southeast Regional Research Group

**State:** Georgia

**Zip:** 31326

**Location 25:**

**City:** Evansville

**Country:** United States

**Facility:** Medisphere Medical Research Center

**State:** Indiana

**Zip:** 47714

**Location 26:**

**City:** Iowa City

**Country:** United States

**Facility:** University of Iowa Hospitals and Clinics

**State:** Iowa

**Zip:** 52242

**Location 27:**

**City:** Hazard

**Country:** United States

**Facility:** Kentucky Lung Clinic

**State:** Kentucky

**Zip:** 41701

**Location 28:**

**City:** Lafayette

**Country:** United States

**Facility:** Bendel Medical Research Center, LLC

**State:** Louisiana

**Zip:** 70503

**Location 29:**

**City:** Ann Arbor

**Country:** United States

**Facility:** ClinSite LLC

**State:** Michigan

**Zip:** 48106

**Location 30:**

**City:** Minneapolis

**Country:** United States

**Facility:** Clinical Research Institute Inc.

**State:** Minnesota

**Zip:** 55402

**Location 31:**

**City:** St. Charles

**Country:** United States

**Facility:** Midwest Chest Consultants

**State:** Missouri

**Zip:** 63301

**Location 32:**

**City:** St. Louis

**Country:** United States

**Facility:** C.A.R.E. Clinical Research

**State:** Missouri

**Zip:** 63141

**Location 33:**

**City:** Berlin

**Country:** United States

**Facility:** Comprehensive Clinical Research

**State:** New Jersey

**Zip:** 08009

**Location 34:**

**City:** Cherry Hill

**Country:** United States

**Facility:** Delaware Valley Clinical Research

**State:** New Jersey

**Zip:** 08003

**Location 35:**

**City:** New York

**Country:** United States

**Facility:** New York Pulmonary and Clinical Care Associates, PC

**State:** New York

**Zip:** 10016

**Location 36:**

**City:** Newburgh

**Country:** United States

**Facility:** ENT & Allergy Associates

**State:** New York

**Zip:** 12550

**Location 37:**

**City:** Rochester

**Country:** United States

**Facility:** Rochester Clinical Research

**State:** New York

**Zip:** 14609

**Location 38:**

**City:** Rochester

**Country:** United States

**Facility:** AAIR Research Center

**State:** New York

**Zip:** 14618

**Location 39:**

**City:** Charlotte

**Country:** United States

**Facility:** American Health Research Inc.

**State:** North Carolina

**Zip:** 28207

**Location 40:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Piedmont Medical Research

**State:** North Carolina

**Zip:** 27103

**Location 41:**

**City:** Akron

**Country:** United States

**Facility:** DayStar Clinical Research, Inc.

**State:** Ohio

**Zip:** 44313

**Location 42:**

**City:** Cincinnati

**Country:** United States

**Facility:** Bernstein Clinical Research Center

**State:** Ohio

**Zip:** 45231

**Location 43:**

**City:** Medford

**Country:** United States

**Facility:** Clinical Research Institute of Southern Oregon, PC

**State:** Oregon

**Zip:** 97504

**Location 44:**

**City:** Portland

**Country:** United States

**Facility:** Allergy Associates Research Center

**State:** Oregon

**Zip:** 97216

**Location 45:**

**City:** Philadelphia

**Country:** United States

**Facility:** Arcuri Clinical Research, LLC

**State:** Pennsylvania

**Zip:** 19142

**Location 46:**

**City:** Pawtucket

**Country:** United States

**Facility:** Biomedical Research Alliance at Hypertension and Nephrology

**State:** Rhode Island

**Zip:** 02860

**Location 47:**

**City:** Warwick

**Country:** United States

**Facility:** Omega Medical Research

**State:** Rhode Island

**Zip:** 02886

**Location 48:**

**City:** Charleston

**Country:** United States

**Facility:** Lowcountry Lung & Critical Care, PA

**State:** South Carolina

**Zip:** 29406

**Location 49:**

**City:** Columbia

**Country:** United States

**Facility:** Neem Research Group, Inc.

**State:** South Carolina

**Zip:** 29201

**Location 50:**

**City:** Gaffney

**Country:** United States

**Facility:** Gaffney Pharmaceutical Research

**State:** South Carolina

**Zip:** 29340

**Location 51:**

**City:** Greenville

**Country:** United States

**Facility:** Greenville Pharmaceutical Research

**State:** South Carolina

**Zip:** 29615

**Location 52:**

**City:** Greenville

**Country:** United States

**Facility:** Upstate Pharmaceutical Research

**State:** South Carolina

**Zip:** 29615

**Location 53:**

**City:** Greer

**Country:** United States

**Facility:** Mountain View Clinical Research, Inc.

**State:** South Carolina

**Zip:** 29651

**Location 54:**

**City:** Spartanburg

**Country:** United States

**Facility:** S. Carolina Pharmaceutical Research

**State:** South Carolina

**Zip:** 29303

**Location 55:**

**City:** Union

**Country:** United States

**Facility:** CU Pharmaceutical Research

**State:** South Carolina

**Zip:** 29379

**Location 56:**

**City:** Knoxville

**Country:** United States

**Facility:** Allergy Associates

**State:** Tennessee

**Zip:** 37909

**Location 57:**

**City:** Knoxville

**Country:** United States

**Facility:** Volunteer Research Group

**State:** Tennessee

**Zip:** 37920

**Location 58:**

**City:** Arlington

**Country:** United States

**Facility:** DCT

**State:** Texas

**Zip:** 76014

**Location 59:**

**City:** Houston

**Country:** United States

**Facility:** Baylor College of Medicine, Clinical Studies Unit, Ben Taub General Hospital

**State:** Texas

**Zip:** 77030

**Location 60:**

**City:** Houston

**Country:** United States

**Facility:** VAMC

**State:** Texas

**Zip:** 77030

**Location 61:**

**City:** Kingwood

**Country:** United States

**Facility:** Kingwood Research Institute, LLC

**State:** Texas

**Zip:** 77339

**Location 62:**

**City:** San Antonio

**Country:** United States

**Facility:** Physician PrimeCare Research

**State:** Texas

**Zip:** 78212

**Location 63:**

**City:** San Antonio

**Country:** United States

**Facility:** Diagnostics Research Group

**State:** Texas

**Zip:** 78229

**Location 64:**

**City:** Sugar Land

**Country:** United States

**Facility:** DCT

**State:** Texas

**Zip:** 77878

**Location 65:**

**City:** Webster

**Country:** United States

**Facility:** SouthEast Research Institute

**State:** Texas

**Zip:** 77598

**Location 66:**

**City:** Provo

**Country:** United States

**Facility:** National Clinical Resources, Inc.

**State:** Utah

**Zip:** 84604

**Location 67:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Utah Clinical Trials LLC

**State:** Utah

**Zip:** 84107

**Location 68:**

**City:** Charlottesville

**Country:** United States

**Facility:** Charlottesville Medical Research Inc.

**State:** Virginia

**Zip:** 22911

**Location 69:**

**City:** Manassas

**Country:** United States

**Facility:** Manassas Clinical Research Center

**State:** Virginia

**Zip:** 20110

**Location 70:**

**City:** Richmond

**Country:** United States

**Facility:** Dominion Medical Associates

**State:** Virginia

**Zip:** 23219

**Location 71:**

**City:** Richmond

**Country:** United States

**Facility:** Pulmonary Associates of Richmond Inc.

**State:** Virginia

**Zip:** 23225

**Location 72:**

**City:** Richmond

**Country:** United States

**Facility:** Pulmonary Associates of Richmond, Inc.

**State:** Virginia

**Zip:** 23229

**Location 73:**

**City:** Tacoma

**Country:** United States

**Facility:** Pulmonary Consultants, PLLC

**State:** Washington

**Zip:** 98405

### References Module

#### References

**Citation:** Donohue JF, Ganapathy V, Bollu V, Stensland MD, Nelson LM. Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year. Clin Ther. 2017 Jan;39(1):66-74. doi: 10.1016/j.clinthera.2016.11.021. Epub 2016 Dec 20.

**PMID:** 28011247

**Citation:** Donohue JF, Hanania NA, Make B, Miles MC, Mahler DA, Curry L, Tosiello R, Wheeler A, Tashkin DP. One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD. Chest. 2014 Dec;146(6):1531-1542. doi: 10.1378/chest.14-0117.

**PMID:** 25451347

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Intervention Browse Module - Ancestors

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000058666

- Term: Adrenergic beta-2 Receptor Agonists

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M3767

- Name: Albuterol

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M304

- Name: Formoterol Fumarate

- Relevance: HIGH

- As Found: Chicago

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068759

- Term: Formoterol Fumarate

### Misc Info Module

#### Removed Countries

- Country: Albania

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo Comparator: Placebo Twice Daily

**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

**ID:** EG000

**Other Num Affected:** 180

**Other Num at Risk:** 421

**Serious Number Affected:** 95

**Serious Number At Risk:** 421

**Title:** Placebo Comparator: Placebo Twice Daily

**Group ID:** EG001

**Title:** Experimental: Arformoterol 15 Mcg Twice Daily

**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

**ID:** EG001

**Other Num Affected:** 174

**Other Num at Risk:** 420

**Serious Number Affected:** 86

**Serious Number At Risk:** 420

**Title:** Experimental: Arformoterol 15 Mcg Twice Daily

**Frequency Threshold:** 5

#### Other Events

**Term:** Bronchitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Nasopharyngitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Sinusitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Upper respiratory tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Chronic obstructive pulmonary disease

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Dyspnoea

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

#### Serious Events

**Term:** Anemia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Leukocytosis

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Acute coronary syndrome

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Acute myocardial infarction

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Angina pectoris

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 3

**Term:** Angina Unstable

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Atrial fibrillation

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 3

**Term:** Atrioventricular block complete

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Bundle branch block right

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Cardiac failure congestive

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 421

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Cardio-respiratory arrest

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Cardiomyopathy

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Corpulmonale

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Coronary artery disease

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 3

**Term:** Myocardial infarction

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Myocardial ischaemia

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Vertigo

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 2

**Term:** Iridocyclitis

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Retinal artery occlusion

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Abdominal pain

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Abdominal pain upper

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Barrett's oesophagus

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Colonic polyp

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Diverticular perforation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Enteritis

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Gastric ulcer

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Gastric ulcer haemorrhage

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Gastritis erosive

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Gastrointestinal haemorrhage

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Gastrooesophageal reflux disease

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hiatus hernia

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Intestinal perforation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Pancreatitis acute

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Rectal haemorrhage

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Small intestinal obstruction

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Non-cardiac chest pain

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 3

**Term:** Oedema peripheral

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Cholecystitis

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Gallbladder perforation

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Abscess limb

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Bronchitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 421

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 4

**Term:** Bronchopneumonia

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Cellulitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Clostridial infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Clostridium difficile colitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Diverticulitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Gastritis fungal

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Gastroenteritis bacteria

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Influenza

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Osteomyelitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Osteomy

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Osteomyelitis acute

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Peridiverticular abscess

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Pneumonia

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 14

**Num At Risk:** 421

**Num Events:** 18

**Group ID:** EG001

**Num Affected:** 12

**Num At Risk:** 420

**Num Events:** 13

**Term:** Postoperative wound infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Sepsis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 420

**Num Events:** 3

**Term:** Septic shock

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Urinary tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Accidental overdose

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Alcohol poisoning

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 4

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Ankle fracture

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Cervical vertebral fracture

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Fibula fracture

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Head injury

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Incisional hernia

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Injury

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Open wound

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Thermal burn

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Tibia fracture

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Toxicity to various agents

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Blood phosphorus decreased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Dehydration

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Diabetes mellitus inadequate control

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hypocalcaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hypokalaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Arthralgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Cervical spinal stenosis

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Intervertebral disc protrusion

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Muscular weakness

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Musculoskeletal chest pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Rotator cuff syndrome

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Bladder cancer

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Brain neoplasm

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Breast cancer

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Lung neoplasm malignant

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Metastases to lymph nodes

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Oesophageal carcinoma

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Squamous cell carcinoma

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Throat cancer

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Altered state of consciousness

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Ataxia

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Carotid artery aneurysm

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Carotid artery disease

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Cerebrovascular accident

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Ischaemic stroke

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Sensory disturbance

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Syncope

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Transient ischaemic attack

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Affective disorder

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 4

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Alcohol withdrawal syndrome

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Depression

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Major depression

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Mental status changes

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Haematuria

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Nephropathy

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Renal artery stenosis

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Renal failure

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Renal failure acute

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Urethral obstruction

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Urinary retention

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Acute respiratory distress syndrome

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Acute respiratory failure

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 421

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Bronchiectasis

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Bronchospasm

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Chronic obstructive pulmonary disease

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 55

**Num At Risk:** 421

**Num Events:** 76

**Group ID:** EG001

**Num Affected:** 35

**Num At Risk:** 420

**Num Events:** 44

**Term:** Haemoptysis

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hypoxia

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Pleuritic pain

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Pneumothorax

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Pulmonary embolism

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Respiratory arrest

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Respiratory distress

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Respiratory failure

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 421

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Urticaria

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Aortic aneurysm

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Hypertension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hypertensive crisis

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Hypertensive emergency

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Term:** Hypotension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** Iliac artery stenosis

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 420

**Num Events:** 2

**Term:** Peripheral arterial occlusive disease

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 421

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 420

**Num Events:** 1

**Term:** C-reactive protein increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 421

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 420

**Time Frame:** 1 year

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 421

**Group ID:** BG001

**Value:** 420

**Group ID:** BG002

**Value:** 841

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo Comparator: Placebo Twice Daily

**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

### Group

**ID:** BG001

**Title:** Experimental: Arformoterol 15 Mcg Twice Daily

**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 222

#### Measurement

**Group ID:** BG001

**Value:** 204

#### Measurement

**Group ID:** BG002

**Value:** 426

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 199

#### Measurement

**Group ID:** BG001

**Value:** 216

#### Measurement

**Group ID:** BG002

**Value:** 415

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.5

**Value:** 63.3

#### Measurement

**Group ID:** BG001

**Spread:** 9.3

**Value:** 64.2

#### Measurement

**Group ID:** BG002

**Spread:** 9.4

**Value:** 63.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 178

#### Measurement

**Group ID:** BG001

**Value:** 183

#### Measurement

**Group ID:** BG002

**Value:** 361

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 243

#### Measurement

**Group ID:** BG001

**Value:** 236

#### Measurement

**Group ID:** BG002

**Value:** 479

**Class Title:** Male

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Undifferentiated

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 24

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 402

#### Measurement

**Group ID:** BG001

**Value:** 411

#### Measurement

**Group ID:** BG002

**Value:** 813

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 43

#### Measurement

**Group ID:** BG001

**Value:** 45

#### Measurement

**Group ID:** BG002

**Value:** 88

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 374

#### Measurement

**Group ID:** BG001

**Value:** 372

#### Measurement

**Group ID:** BG002

**Value:** 746

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 421

#### Measurement

**Group ID:** BG001

**Value:** 420

#### Measurement

**Group ID:** BG002

**Value:** 841

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.1

**Value:** 0.8

#### Measurement

**Group ID:** BG001

**Spread:** 1.4

**Value:** 1.0

#### Measurement

**Group ID:** BG002

**Spread:** 1.3

**Value:** 0.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.487

**Value:** 1.178

#### Measurement

**Group ID:** BG001

**Spread:** 0.482

**Value:** 1.176

#### Measurement

**Group ID:** BG002

**Spread:** 0.485

**Value:** 1.177

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.9

**Value:** 39.4

#### Measurement

**Group ID:** BG001

**Spread:** 13.2

**Value:** 39.7

#### Measurement

**Group ID:** BG002

**Spread:** 13.5

**Value:** 39.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 218

#### Measurement

**Group ID:** BG001

**Value:** 214

#### Measurement

**Group ID:** BG002

**Value:** 432

**Class Title:** Current

#### Measurement

**Group ID:** BG000

**Value:** 203

#### Measurement

**Group ID:** BG001

**Value:** 206

#### Measurement

**Group ID:** BG002

**Value:** 409

**Class Title:** Former

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.7

**Value:** 41

#### Measurement

**Group ID:** BG001

**Spread:** 9.5

**Value:** 40

#### Measurement

**Group ID:** BG002

**Spread:** 9.6

**Value:** 81

**Class Title:** ≥ 15 - < 25

#### Measurement

**Group ID:** BG000

**Spread:** 8.6

**Value:** 36

#### Measurement

**Group ID:** BG001

**Spread:** 6.9

**Value:** 29

#### Measurement

**Group ID:** BG002

**Spread:** 7.7

**Value:** 65

**Class Title:** ≥ 25 - < 30

#### Measurement

**Group ID:** BG000

**Spread:** 81.7

**Value:** 344

#### Measurement

**Group ID:** BG001

**Spread:** 83.6

**Value:** 351

#### Measurement

**Group ID:** BG002

**Spread:** 82.6

**Value:** 695

**Class Title:** ≥ 30

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 48.0

**Value:** 202

#### Measurement

**Group ID:** BG001

**Spread:** 48.1

**Value:** 202

#### Measurement

**Group ID:** BG002

**Spread:** 48.0

**Value:** 404

**Class Title:** No

#### Measurement

**Group ID:** BG000

**Spread:** 52.0

**Value:** 219

#### Measurement

**Group ID:** BG001

**Spread:** 51.9

**Value:** 218

#### Measurement

**Group ID:** BG002

**Spread:** 52.0

**Value:** 437

**Class Title:** Yes

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 78.4

**Value:** 330

#### Measurement

**Group ID:** BG001

**Spread:** 79.5

**Value:** 334

#### Measurement

**Group ID:** BG002

**Spread:** 79.0

**Value:** 664

**Class Title:** No

#### Measurement

**Group ID:** BG000

**Spread:** 21.6

**Value:** 91

#### Measurement

**Group ID:** BG001

**Spread:** 20.5

**Value:** 86

#### Measurement

**Group ID:** BG002

**Spread:** 21.0

**Value:** 177

**Class Title:** Yes

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 7
**Description:** The average number of COPD exacerbations during the previous year
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Number of COPD exacerbations in last year
**Unit of Measure:** Number of occurrences
### Measure 8
**Description:** FEV1: Forced expiratory volume in one second. FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at Visits 2 through 5, and at Visit 6/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** FEV1
**Unit of Measure:** Liter
### Measure 9
**Description:** Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at Visits 2 through 5, and at Visit 6/EOS, as described for FEV1.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Percent predicted FEV1 (%)
**Unit of Measure:** Percentage (%)
### Measure 10
**Description:** Smoking status was recorded at each visit. At baseline, a subject was only defined as a former smoker if they had given up smoking at least 6 calendar months prior to the Visit 1 (screening) date based on the smoking cessation date. Otherwise, they were classified as a current smoker.
**Parameter Type:** NUMBER
**Title:** Baseline smoking status
**Unit of Measure:** Current
### Measure 11
**Description:** Number of pack-years smoked was defined as the number of cigarette packs smoked per day times the number of years smoked.
**Parameter Type:** NUMBER
**Title:** Number of pack-years smoked
**Unit of Measure:** Pack-years
### Measure 12
**Description:** Oral or inhaled corticosteroid use
**Parameter Type:** NUMBER
**Title:** Baseline Oral/Inhaled Corticosteroid Use
**Unit of Measure:** participants
### Measure 13
**Description:** Oxygen therapy use at baseline
**Parameter Type:** NUMBER
**Title:** Baseline Oxygen Therapy Use
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Although LABAs other than study medication were discontinued, other medications were not controlled for. A large number of subjects discontinued after a primary event and their eventual outcomes are unknown.
### Point of Contact
**Organization:** Sunovion
**Phone:** 1-866-503-6351
**Title:** Respiratory Medical Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.425
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.864
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Hazard ratio was calculated as arformoterol vs. placebo.
**Group Description:** The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).

The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated.
**Non-Inferiority Comment:** The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).

The non-inferiority margin for the hazard ratio is 1.4.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.606
**Statistical Comment:** 
**Statistical Method:** Regression, Cox
**Tested Non-Inferiority:** True
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.425
- **Spread:** 91.2
- **Upper Limit:** 0.864
- **Value:** 155.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 98.7
- **Upper Limit:** 
- **Value:** 171.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 132
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 122
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 287
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 306
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.609
- **Upper Limit:** 
- **Value:** -1.544
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.575
- **Upper Limit:** 
- **Value:** -3.876
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.746
- **Upper Limit:** 
- **Value:** -1.855
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.679
- **Upper Limit:** 
- **Value:** -4.054
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.800
- **Upper Limit:** 
- **Value:** -2.673
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.735
- **Upper Limit:** 
- **Value:** -4.796
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.616
- **Upper Limit:** 
- **Value:** -0.587
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.613
- **Upper Limit:** 
- **Value:** -3.231
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.018
- **Upper Limit:** 
- **Value:** 0.027
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.016
- **Upper Limit:** 
- **Value:** 0.093
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.023
- **Upper Limit:** 
- **Value:** 0.036
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.021
- **Upper Limit:** 
- **Value:** 0.090
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.019
- **Upper Limit:** 
- **Value:** 0.048
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.018
- **Upper Limit:** 
- **Value:** 0.092
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.020
- **Upper Limit:** 
- **Value:** 0.020
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.018
- **Upper Limit:** 
- **Value:** 0.059
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.016
- **Upper Limit:** 
- **Value:** 0.047
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.016
- **Upper Limit:** 
- **Value:** 0.072
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.533
- **Upper Limit:** 
- **Value:** 1.410
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.498
- **Upper Limit:** 
- **Value:** 3.480
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.648
- **Upper Limit:** 
- **Value:** 1.768
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.594
- **Upper Limit:** 
- **Value:** 3.460
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.626
- **Upper Limit:** 
- **Value:** 2.606
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.576
- **Upper Limit:** 
- **Value:** 3.651
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.642
- **Upper Limit:** 
- **Value:** 1.678
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.586
- **Upper Limit:** 
- **Value:** 2.662
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.493
- **Upper Limit:** 
- **Value:** 2.156
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.486
- **Upper Limit:** 
- **Value:** 2.936
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.024
- **Upper Limit:** 
- **Value:** 0.039
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** 0.139
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.031
- **Upper Limit:** 
- **Value:** 0.056
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.028
- **Upper Limit:** 
- **Value:** 0.120
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.029
- **Upper Limit:** 
- **Value:** 0.049
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.027
- **Upper Limit:** 
- **Value:** 0.139
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.029
- **Upper Limit:** 
- **Value:** 0.040
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.027
- **Upper Limit:** 
- **Value:** 0.088
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** 0.056
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** 0.102
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.023
- **Upper Limit:** 
- **Value:** 0.030
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.021
- **Upper Limit:** 
- **Value:** 0.054
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.026
- **Upper Limit:** 
- **Value:** -0.011
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.024
- **Upper Limit:** 
- **Value:** 0.067
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.029
- **Upper Limit:** 
- **Value:** 0.046
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.027
- **Upper Limit:** 
- **Value:** 0.096
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.029
- **Upper Limit:** 
- **Value:** 0.004
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.027
- **Upper Limit:** 
- **Value:** 0.035
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** 0.031
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.021
- **Upper Limit:** 
- **Value:** 0.058
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** 0-12 months
**Title:** Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).
**Type:** PRIMARY
**Type Units Analyzed:** Subjects with Primary Event
**Unit of Measure:** Days
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG000
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
##### Group
**Description:** Placebo twice daily
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).
**Parameter Type:** NUMBER
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** 0-12 months
**Title:** The Incidence of Protocol Defined COPD Exacerbations.
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 3
**Description:** Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** 0-12 months
**Title:** The Incidence of All Cause Mortality
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 4
**Description:** TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.

The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** 0-12 months
**Title:** The Incidence of Treatment Emergent AEs
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 5
**Description:** The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline and on treatment at months 3, 6 and 12 (or early termination)
**Title:** SGRQ: Mean Change From Baseline in Total Score
**Type:** SECONDARY
**Unit of Measure:** Score
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 6
**Description:** FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)
**Title:** FEV1: Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 7
**Description:** Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)
**Title:** Percent Predicted FEV1: Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 8
**Description:** Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)
**Title:** Forced Vital Capacity (FVC): Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
#### Outcome Measure 9
**Description:** IC: the total amount of air that can be drawn into the lungs after normal expiration.

IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)
**Title:** Inspiratory Capacity (IC): Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
**ID:** OG000
**Title:** Placebo Comparator: Placebo Twice Daily
##### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** OG001
**Title:** Experimental: Arformoterol 15 Mcg Twice Daily
### Participant Flow Module
#### Group
**Description:** Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** FG000
**Title:** Placebo Twice Daily
#### Group
**Description:** Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
**ID:** FG001
**Title:** Arformoterol 15 Mcg Twice Daily
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 53
###### Reason
**Group ID:** FG001
**Number of Subjects:** 55
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 19
###### Reason
**Group ID:** FG001
**Number of Subjects:** 15
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 116
###### Reason
**Group ID:** FG001
**Number of Subjects:** 80
##### Withdraw
**Type:** Site Ceasing Operation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Medical Monitor Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Randomized in error
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 421
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 420
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 211
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 255
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 210
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 165
**Has Results:** True