A Long-term Safety Study of Fixed Dose Combination Therap... | NCT03184987

Name	Class
York Bioanalytical Solution	INDUSTRY
BI Medical.Inc.	INDUSTRY
SRL Medisearch Inc.	INDUSTRY
Parexel

Label	Type	Description	Intervention Names
FF/UMEC/VI 100/62.5/25 mcg closed triple therapy	Experimental	Subjects will receive FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA, once daily, 1 puff/time, in the morning. Subjects may receive salbutamol as a rescue medication when needed throughout the run-in and treatment period.	Drug: FF/UMEC/VI 100/62.5/25 mcg Drug: Salbutamol Other: ACQ-7
FF/UMEC/VI 200/62.5/25 mcg closed triple therapy	Experimental	Subjects will receive FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA, once daily, 1 puff/time, in the morning. Subjects may receive salbutamol as a rescue medication when needed throughout the run-in and treatment period.	Drug: FF/UMEC/VI 200/62.5/25 mcg Drug: Salbutamol Other: ACQ-7

Name	Type	Description	Arm Group Labels	Other Names
FF/UMEC/VI 100/62.5/25 mcg	Drug	Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister. ELLIPTA is a registered trademark of GSK groups of companies.

Measure	Description	Time Frame
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period.	Up to Week 52

Measure	Description	Time Frame
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.	Baseline (Day 1), Weeks 4, 12, 24, 36 and 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria at the time of informed consent (Visit 0) and at screening (Visit 1).

Age: Participant must be 18 years of age or older at the time of signing the informed consent.
Ethnicity: Japanese
Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to providing informed consent.
Current Asthma Maintenance Therapy: Outpatients are eligible if they have received ICS+LABA or ICS+LABA＋LAMA with asthma control status as Not well controlled with ICS (mid-dose) +LABA ; Not well controlled with ICS (high-dose) +LABA or Controlled with ICS (mid-dose) +LABA + LAMA; Not well controlled with ICS (mid-dose) +LABA + LAMA; Controlled with ICS (high-dose) +LABA + LAMA respectively in stable regimen and dosage for at least 4 weeks prior to screening visit (Visit 1) (with medium to high dose of ICS defined by the Japanese Guidelines [JGL]). Asthma Control Questionnaire (ACQ-6) will be used for the assessment of control status of asthma at Visit 1 (screening Visit) (i.e., less than or equal to 0.75 points shows controlled and > 0.75 shows not well controlled).
Short-Acting Beta Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects should be able to withhold salbutamol for at least 6 hours prior to clinic visit.
Sex: Male and/or female: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance from the screening visit until after the last dose of study medication and completion of the follow-up visit.
Informed Consent: capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion Criteria at the time of informed consent (Visit 0) and at screening (Visit 1).

Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1.
COPD: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2016) guidelines, including history of exposure to risk factors (i.e., especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels) (for tobacco smoke); post- salbutamol Forced Expiratory Volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of <0.70 and a post- salbutamol FEV1 of less than or equal to 70% of predicted normal values (diagnosis prior to Visit 1 acceptable);Onset of disease greater than or equal to 40 years of age.
Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
Risk Factors for Pneumonia: Immune suppression (e.g., HIV, lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's disease, myasthenia gravis). Patients at potentially high risk (e.g., very low body mass index (BMI), severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria.
Clinically significant ECG abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
- Atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute (bpm)
- Sustained or nonsustained ventricular tachycardia (VT)
- Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted)
- QT interval corrected for heart rate by Fridericia's formula (QTcF) greater than or equal to 500 milliseconds (msec) in patients with QRS <120 msec and QTcF greater than or equal to 530 msec in patients with QRS greater than or equal to 120 msec.
Unstable or life threatening cardiac disease: subjects with any of the following at screening (Visit 1) would be excluded:
- Myocardial infarction or unstable angina in the last 6 months
- Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
- New York Heart Association (NYHA) Class IV heart failure
Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment.
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
Medication prior to spirometry: Subjects who are medically unable to withhold their salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
Allergy or hypersensitivity: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta-agonist, lactose/severe milk protein or magnesium stearate.
Tobacco use: Subjects who are: Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to Visit 1 [i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco]); Former smokers with a smoking history of greater than equal to 10 pack years (e.g., greater than equal to 20 cigarettes/day for 10 years).
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Affiliation with Investigator site: Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials.

Inclusion Criteria end of the run-in period (Visit 2)

Asthma maintenance therapy: No changes in asthma maintenance therapy (excluding salbutamol inhalation aerosol provided at Visit 1) and control status during the run-in period. Asthma Control Questionnaire (ACQ-6 at screening and ACQ-7 at the end of the run-in period) will be used for the assessment of control status of asthma, i.e., 0.75 points shows controlled and >0.75 shows not well controlled.
Concurrent conditions/medical history: Liver function test at Visit1
- ALT <2 x upper limit of normal (ULN)
- ALP less than or equal to 1.5 x ULN
- Bilirubin less than or equal to 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

Exclusion Criteria end of the run-in period (Visit 2)

Respiratory Infection: Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
Severe asthma exacerbation: Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Laboratory test abnormalities: Evidence of clinically significant abnormal laboratory tests during screening or the run-in period which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
There is no restriction on diet in this study.
Use of tobacco products will not be allowed from screening until after the final follow-up visit. Caffeine and alcohol is allowed ad libitum.
There is no restriction on activity in this study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Gifu		509-6134	Japan
GSK Investigational Site

ID	Title	Description
FG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 microgram (mcg) inhalation powder via ELLIPTA, once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
FG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 17, 2018	Apr 24, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period.

ITT Population.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
OG002	FF/UMEC/VI 200/62.5/25 mcg	Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Units	Counts
Participants	OG00047 OG0019 OG00255

Title

Denominators

Categories

Non-SAEs

Title	Measurements
	OG00023 OG0017 OG00232

SAEs

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Millimeters of mercury

Baseline (Day 1), Weeks 4, 12, 24, 36 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Pulse Rate

Pulse rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Day 1), Weeks 4, 12, 24, 36 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)

Single 12-lead electrocardiograms (ECG) were obtained using an automated ECG machine that measured PR Interval and QTcF Interval. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Milliseconds

Baseline (Day 1), Weeks 4, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Picograms

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Femtoliters

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

10^12 cells per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of red blood cells in blood

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Grams per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Platelet Count

Blood samples were collected to analyze the hematology parameter: platelet count. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

10^9 cells per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Basophils/Leukocytes

Blood samples were collected to analyze the hematology parameter: Basophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of basophil in leukocytes

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes

Blood samples were collected to analyze the hematology parameter: Eosinophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of eosinophils in leukocytes

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes

Blood samples were collected to analyze the hematology parameter: Lymphocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of lymphocytes in leukocytes

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Monocytes/Leukocytes

Blood samples were collected to analyze the hematology parameter: Monocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of monocytes in leukocytes

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes

Blood samples were collected to analyze the hematology parameter: Neutrophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Percentage of neutrophils in leukocytes

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase

Blood samples were collected to analyze the chemistry parameters: alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

International units per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Chemistry Parameters: Albumin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin and protein. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Grams per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Micromoles per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and urea. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Millimoles per liter

Baseline (Day 1), Weeks 12, 24 and 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Secondary

Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as Trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

ITT Population.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to Week 52

ID	Title	Description
OG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
OG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00013 affected47 at risk EG0012 affected9 at risk EG00218 affected55 at risk
Pharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected47 at risk EG0012 affected9 at risk EG0024 affected55 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected47 at risk EG0012 affected9 at risk EG0024 affected55 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected47 at risk EG0011 affected9 at risk EG0025 affected55 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected47 at risk EG0011 affected9 at risk EG0022 affected55 at risk
Rhinitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected47 at risk EG0010 affected9 at risk EG0023 affected55 at risk
Acute sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected47 at risk EG0011 affected9 at risk EG0022 affected55 at risk
Chronic sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Helicobacter infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Hordeolum	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Vaginal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Dysgeusia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected47 at risk EG0012 affected9 at risk EG0026 affected55 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected47 at risk EG0010 affected9 at risk EG0023 affected55 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected47 at risk EG0010 affected9 at risk EG0023 affected55 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected47 at risk EG0011 affected9 at risk EG0025 affected55 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0021 affected55 at risk
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0021 affected55 at risk
Eosinophil count increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Low density lipoprotein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected47 at risk EG0011 affected9 at risk EG0021 affected55 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Eustachian tube stenosis	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk
Pterygium	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0011 affected9 at risk EG0020 affected55 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

ID	Title	Description
BG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
BG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
BG002	FF/UMEC/VI 200/62.5/25 mcg	Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FF/UMEC/VI 100/62.5/25 mcg	Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.	47	1	47	23	47
EG001	FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg	Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score >0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.	9	0	9	7	9
EG002	FF/UMEC/VI 200/62.5/25 mcg	Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.	55	2	55	32	55

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eosinophilic granulomatosis with polyangiitis	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0010 affected9 at risk EG0021 affected55 at risk
Appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected47 at risk EG0010 affected9 at risk EG0020 affected55 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected47 at risk EG0010 affected9 at risk EG0021 affected55 at risk