Trial Outcomes & Findings for A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD (NCT NCT01192191)

NCT ID: NCT01192191

Last Updated: 2017-01-11

Results Overview

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Results posted on

2017-01-11

Participant Flow

A 2-week Run-in Period was used to obtain Baseline assessment of participants. The Run-in Period was followed by a 52-week Double-blind Treatment Period and a 1-week Follow-up Period.

Participant milestones

Participant milestones
Measure	FF/VI 100/25 µg Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Overall Study STARTED	60	127
Overall Study COMPLETED	49	106
Overall Study NOT COMPLETED	11	21

Reasons for withdrawal

Reasons for withdrawal
Measure	FF/VI 100/25 µg Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Overall Study Adverse Event	7	12
Overall Study Participants Reached Stopping Criteria	3	2
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	6

Baseline Characteristics

A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.	Total n=187 Participants Total of all reporting groups
Age, Continuous	69.5 Years STANDARD_DEVIATION 7.66 • n=5 Participants	71.0 Years STANDARD_DEVIATION 7.39 • n=7 Participants	70.5 Years STANDARD_DEVIATION 7.49 • n=5 Participants
Gender Female	2 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants
Gender Male	58 Participants n=5 Participants	116 Participants n=7 Participants	174 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	60 Participants n=5 Participants	127 Participants n=7 Participants	187 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Population: Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period Any SAE	10 Participants	23 Participants
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period Any Non-serious AE	36 Participants	93 Participants

PRIMARY outcome

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Population: ITT Population

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period Any AE	12 Participants	30 Participants
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period Any SAE	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Population: ITT Population

Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants With Pneumonia During the Treatment Period Pneumonia recorded as an AE	6 Participants	19 Participants
Number of Participants With Pneumonia During the Treatment Period Pneumonia recorded as an SAE	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD)

Population: ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by "n=X, X".

Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, High, Week 52/WD, n=56, 122	3 Participants	4 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, Normal, Week 52/WD, n=56, 122	52 Participants	116 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, Normal, BL, n= 60, 127	58 Participants	127 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, High, Week 52/WD, n=56, 122	1 Participants	1 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, High, BL, n=60, 127	5 Participants	15 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, Normal, Week 52/WD, n=56, 122	51 Participants	111 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, High, BL, n=60, 127	1 Participants	1 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, Low, BL, n=60, 127	1 Participants	5 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, High, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, Normal, Week 52/WD, n=56, 122	51 Participants	108 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, Low, Week 52/WD, n=56, 122	5 Participants	14 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, Normal, BL, n=60, 127	58 Participants	119 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, Low, BL, n=60, 127	11 Participants	13 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, Low, BL, n=60, 127	6 Participants	4 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, High, Week 52/WD, n=56, 122	1 Participants	8 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, Normal, Week 52/WD, n=56, 122	50 Participants	106 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, Low, Week 52/WD, n=56, 122	5 Participants	8 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, Normal, BL, n=60, 127	57 Participants	124 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, Low, BL, n=60, 127	2 Participants	3 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, High, Week 52/WD, n=56, 122	2 Participants	4 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, Normal, Week 52/WD, n=56, 122	51 Participants	116 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, Low, Week 52/WD, n=56, 122	3 Participants	2 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, Normal, BL, n=60, 127	53 Participants	111 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, Low, Week 52/WD, n=56, 122	9 Participants	13 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, Low, BL, n=60, 127	1 Participants	2 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, High, BL, n=60, 127	4 Participants	13 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hmcrt, Normal, BL, n=60, 127	50 Participants	110 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) PT, High, BL, n=60, 127	1 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, High, BL, n=60, 127	0 Participants	4 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, Low, BL, n=60, 127	7 Participants	12 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, High, Week 52/WD, n=56, 122	0 Participants	2 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) RBC Count, Normal, Week 52/WD, n=56, 122	47 Participants	107 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, High, BL, n=60, 127	2 Participants	6 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, Normal, BL, n=60, 127	57 Participants	119 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) WBC Count, Low, Week 52/WD, n=56, 122	1 Participants	2 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, High, BL, n=60, 127	2 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, Low, BL, n= 60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, Normal, Week 52/WD, n=56, 122	55 Participants	121 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Baso, Low, Week 52/WD n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, Normal, BL, n=60, 127	55 Participants	112 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, High, Week 52/WD, n=56, 122	5 Participants	11 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Eosin, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Lymph, Normal, BL, n=60, 127	58 Participants	121 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, High, BL, n=60, 127	9 Participants	8 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, Normal, BL, n=60, 127	51 Participants	119 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, High, Week 52/WD, n=56, 122	7 Participants	14 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, Normal, Week 52/WD, n=56, 122	49 Participants	108 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Mono, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, High, BL, n=60, 127	0 Participants	5 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, Low, BL, n=60, 127	2 Participants	3 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, High, Week 52/WD, n=56, 122	4 Participants	11 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, Normal, Week 52/WD, n=56, 122	52 Participants	111 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TN, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, High, BL, n=60, 127	1 Participants	2 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, Normal, BL, n=60, 127	48 Participants	112 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, High, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, Normal, Week 52/WD, n=56, 122	45 Participants	108 Participants
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Hemo, Low, Week 52/WD, n=56, 122	11 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD

Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct \[BD\], Indirect \[BI\], and Total \[BT\]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, Low, BL, n=60, 127	1 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, High, BL, n=60, 127	0 Participants	2 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, Normal, BL, n=60, 127	56 Participants	112 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, Low, BL, n=60, 127	4 Participants	13 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, High, Week 52/WD, n=56, 122	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, Normal, Week 52/WD, n=56, 122	42 Participants	92 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, Normal, Week 52/WD, n=56, 122	49 Participants	99 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, Normal, BL, n=60, 127	56 Participants	117 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, High, Week 52/WD, n=56, 122	5 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, High, BL, n=60, 127	4 Participants	9 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, Normal, BL, n=60, 127	56 Participants	117 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, Normal, Week 52/WD, n=56, 122	53 Participants	118 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, High, BL, n=60, 127	4 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, Normal, BL, n=60, 127	56 Participants	126 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, High, Week 52/WD, n=56, 122	3 Participants	2 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, Normal, BL, n=60, 127	54 Participants	122 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, High, BL, n=60, 127	6 Participants	10 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, Normal, BL, n=60, 127	48 Participants	102 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, Normal, BL, n=60, 127	58 Participants	124 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, Low, BL, n=60, 127	1 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, Low, Week 52/WD, n=56, 122	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, High, BL, n=60, 127	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, Normal, BL, n=60, 127	57 Participants	120 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, Low, BL, n=60, 127	3 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, High, Week 52/WD, n=56, 121	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, Normal, Week 52/WD, n=56, 121	48 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CO2/BC, Low, Week 52/WD, n=56, 121	8 Participants	4 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, Low, BL, n=60, 127	2 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, High, Week 52/WD, n=56, 122	6 Participants	10 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, Normal, Week 52/WD, n=56, 122	47 Participants	108 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, Normal, BL, n=60, 127	51 Participants	102 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, High, Week 52/WD, n=56, 122	10 Participants	19 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, Normal, Week 52/WD, n=56, 122	46 Participants	103 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, Low, BL, n=60, 127	1 Participants	4 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, High, Week 52/WD, n=56, 122	26 Participants	56 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, Normal, Week 52/WD, n=56, 122	30 Participants	65 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, Low, Week 52/WD, n=56, 122	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, Low, BL, n=60, 127	4 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, High, Week 52/WD, n=56, 122	1 Participants	5 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, Normal, Week 52/WD, n=56, 122	53 Participants	111 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, Normal, BL, n=60, 127	59 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, Low, BL, n=60, 127	0 Participants	2 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, High, Week 52/WD, n=56, 122	4 Participants	10 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, High, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, Low, BL, n=60, 127	2 Participants	2 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, Normal, Week 52/WD, n=56, 122	55 Participants	120 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, Low, Week 52/WD, n=56, 122	1 Participants	2 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, Normal, BL, n=60, 127	60 Participants	126 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, Normal, Week 52/WD, n=56, 122	56 Participants	122 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, High, BL, n=60, 127	2 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, Normal, BL, n=60, 127	58 Participants	126 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, High, Week 52/WD, n=56, 122	2 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, Normal, Week 52/WD, n=56, 122	54 Participants	122 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, High, BL, n=60, 127	1 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, Normal, BL, n=60, 127	55 Participants	118 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, Low, BL, n=60, 127	4 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, High, Week 52/WD, n=56, 122	1 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, Normal, Week 52/WD, n=56, 122	49 Participants	102 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) TP, Low, Week 52/WD, n=56, 122	6 Participants	17 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, High, BL, n=60, 127	5 Participants	13 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, Normal, BL, n=60, 127	54 Participants	114 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, High, Week 52/WD, n=56, 122	8 Participants	5 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, Normal, Week 52/WD, n=56, 122	48 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, Low, Week 52/WD, n=56, 122	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, High, BL, n=60, 127	13 Participants	22 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, Normal, BL, n=60, 127	46 Participants	102 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Albumin, Low, Week 52/WD, n=56, 122	7 Participants	22 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, High, BL, n=60, 127	4 Participants	10 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, Normal, Week 52/WD, n=56, 122	51 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AP, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, Low, BL, n=60, 127	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, High, Week 52/WD, n=56, 122	4 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, Normal, Week 52/WD, n=56, 122	52 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) ALT, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, High, BL, n=60, 127	5 Participants	11 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, Normal, BL, n=60, 127	55 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, High, Week 52/WD, n=56, 122	3 Participants	5 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) AST, Normal, Week 52/WD, n=56, 122	53 Participants	117 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, High, BL, n=60, 127	7 Participants	4 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, Normal, BL, n=60, 127	53 Participants	123 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BD, High, Week 52/WD, n=56, 122	3 Participants	4 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, Normal, Week 52/WD, n=56, 122	53 Participants	120 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BI, Low, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, High, BL, n=60, 127	6 Participants	5 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, High, Week 52/WD, n=56, 122	6 Participants	3 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) BT, Normal, Week 52/WD, n=56, 122	50 Participants	119 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, Low, BL, n=60, 127	6 Participants	15 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, High, Week 52/WD, n=56, 122	7 Participants	7 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, Normal, Week 52/WD, n=56, 122	44 Participants	92 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) CK, Low, Week 52/WD, n=56, 122	5 Participants	23 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, High, BL, n=60, 127	1 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, High, Week 52/WD, n=56, 122	2 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Chloride, Normal, Week 52/WD, n=56, 122	54 Participants	115 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, High, BL, n=60, 127	8 Participants	9 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, Normal, BL, n=60, 127	50 Participants	115 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Creatinine, Low, Week 52/WD, n=56, 122	3 Participants	4 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) GGT, High, BL, n=60, 127	9 Participants	25 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, High, BL, n=60, 127	16 Participants	58 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Glucose, Normal, BL, n=60, 127	43 Participants	65 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, High, BL, n=60, 127	2 Participants	5 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, Normal, BL, n=60, 127	54 Participants	116 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Potassium, Low, Week 52/WD, n=56, 122	2 Participants	6 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, High, BL, n=60, 127	1 Participants	9 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, Normal, Week 52/WD, n=56, 122	52 Participants	111 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) LDH, Low, Week 52/WD, n=56, 122	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, Normal, BL, n=60, 127	58 Participants	125 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Sodium, High, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, High, BL, n=60, 127	0 Participants	1 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urine pH, High, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) USG, Low, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) Urea/BUN, Low, BL, n=60, 127	1 Participants	0 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, High, Week 52/WD, n=56, 122	13 Participants	23 Participants
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) UA, Low, Week 52/WD, n=56, 122	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (Week -2), Week 52/Withdrawal (WD)

Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, Trace, BL, n=60, 127	4 Participants	6 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 1+, BL, n=60, 127	1 Participants	5 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 2+, BL, n=60, 127	1 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 3+, BL, n=60, 127	0 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, Neg, Week 52/WD, n=56, 122	51 Participants	103 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, Trace, Week 52/WD, n=56, 122	3 Participants	11 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 1+, Week 52/WD, n=56, 122	1 Participants	5 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 2+, Week 52/WD, n=56, 122	1 Participants	1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, 3+, Week 52/WD, n=56, 122	0 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, Neg, BL, n=60, 127	54 Participants	117 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, Trace, BL, n=60, 127	3 Participants	4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 1+, BL, n=60, 127	2 Participants	1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 2+, BL, n=60, 127	1 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, Trace, Week 52/WD, n=56, 122	2 Participants	5 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, Neg, BL, n=60, 127	60 Participants	127 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 1+, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 2+, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 3+, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, Neg, Week 52/WD, n=56, 122	56 Participants	122 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, Trace, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 1+, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 3+, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, Neg, BL, n=60, 127	48 Participants	103 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, Trace, BL, n=60, 127	10 Participants	13 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 1+, BL, n=60, 127	2 Participants	8 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 2+, BL, n=60, 127	0 Participants	3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 3+, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 1+, Week 52/WD, n=56, 122	4 Participants	8 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 2+, BL, n=60, 127	0 Participants	1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, Trace, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 1+, Week 52/WD, n=56, 122	1 Participants	11 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 2+, Week 52/WD, n=56, 122	0 Participants	3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UOB, Neg, BL, n=60, 127	54 Participants	112 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 3+, BL, n=60, 127	0 Participants	3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, Neg, Week 52/WD, n=56, 122	49 Participants	109 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 1+, Week 52/WD, n=56, 122	3 Participants	1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 2+, Week 52/WD, n=56, 122	2 Participants	5 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UG, 3+, Week 52/WD, n=56, 122	0 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, Trace, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UK, 2+, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, Neg, Week 52/WD, n=56, 122	41 Participants	92 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, Trace, Week 52/WD, n=56, 122	10 Participants	20 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 2+, Week 52/WD, n=56, 122	1 Participants	2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UP, 3+, Week 52/WD, n=56, 122	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, Neg, BL, n=60, 127	58 Participants	120 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, Trace, BL, n=60, 127	0 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 1+, BL, n=60, 127	1 Participants	6 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 3+, BL, n=60, 127	1 Participants	0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, Neg, Week 52/WD, n=56, 122	55 Participants	108 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) UWBC, 3+, Week 52/WD, n=56, 122	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)

Population: The Urine Cortisol Population: all participants in the ITT Population for whom a urine sample was obtained and whose urine sample was not considered to have confounding factors that could affect the interpretation of the results. Only those participants with post-Baseline data available at the indicated time points were analyzed.

24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=25 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=43 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD) Week 24, n=25, 43	1.0627 Nanomoles (nmol)/24 hours Geometric Coefficient of Variation 76.135	0.8160 Nanomoles (nmol)/24 hours Geometric Coefficient of Variation 55.926
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD) Week 52/WD, n=24, 41	0.8862 Nanomoles (nmol)/24 hours Geometric Coefficient of Variation 37.078	0.8593 Nanomoles (nmol)/24 hours Geometric Coefficient of Variation 52.770

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD

Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.

Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD

Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.

Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=58 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=125 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 8, n=58, 123	-0.2 Beats/Minute Standard Deviation 11.41	0.3 Beats/Minute Standard Deviation 12.06
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 12, n=57, 119	-1.6 Beats/Minute Standard Deviation 9.37	-0.1 Beats/Minute Standard Deviation 11.27
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 16, n=57, 116	0.7 Beats/Minute Standard Deviation 9.50	1.5 Beats/Minute Standard Deviation 12.58
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 24/WD, n=56, 125	-1.1 Beats/Minute Standard Deviation 11.03	-0.7 Beats/Minute Standard Deviation 11.43
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 52/WD, n=56, 123	1.8 Beats/Minute Standard Deviation 10.62	2.0 Beats/Minute Standard Deviation 12.71
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 4, n=58, 124	0.2 Beats/Minute Standard Deviation 9.84	-0.3 Beats/Minute Standard Deviation 11.04
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 24, n=53, 115	-0.7 Beats/Minute Standard Deviation 10.69	-1.1 Beats/Minute Standard Deviation 11.53
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 32, n=53, 112	-0.5 Beats/Minute Standard Deviation 9.23	0.1 Beats/Minute Standard Deviation 10.30
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 40, n=50, 107	1.7 Beats/Minute Standard Deviation 9.66	-0.3 Beats/Minute Standard Deviation 11.59
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD HR, Week 52, n=49, 106	1.9 Beats/Minute Standard Deviation 9.32	1.1 Beats/Minute Standard Deviation 12.12

SECONDARY outcome

Timeframe: Baseline (Week -2), Week 12, Week 24, and Week 52

A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.

Outcome measures

Outcome measures
Measure	FF/VI 100/25 µg n=60 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 12, NCS, n=57, 119	17 Participants	37 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 24, CS, n=54, 115	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings BL, CS, n=60, 127	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings BL, NCS, n=60, 127	19 Participants	43 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 12, CS, n=57, 119	0 Participants	1 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 24, NCS, n=54, 115	17 Participants	33 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 52, CS, n=49, 106	1 Participants	1 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Week 52, NCS, n=49, 106	14 Participants	35 Participants

Adverse Events

FF/VI 100/25 µg

Serious events: 10 serious events

Other events: 36 other events

Deaths: 0 deaths

FF/VI 200/25 µg

Serious events: 23 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FF/VI 100/25 µg n=60 participants at risk Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 participants at risk Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Infections and infestations Pneumonia	5.0% 3/60	6.3% 8/127
Infections and infestations Bacteraemia	0.00% 0/60	0.79% 1/127
Infections and infestations Bronchitis	0.00% 0/60	0.79% 1/127
Infections and infestations Bronchopneumonia	1.7% 1/60	0.00% 0/127
Infections and infestations Diverticulitis	0.00% 0/60	0.79% 1/127
Infections and infestations Osteomyelitis	0.00% 0/60	0.79% 1/127
Infections and infestations Pneumonia bacterial	0.00% 0/60	0.79% 1/127
Infections and infestations Pulmonary mycosis	0.00% 0/60	0.79% 1/127
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.3% 2/60	2.4% 3/127
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/60	0.79% 1/127
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/60	0.79% 1/127
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/60	0.79% 1/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/60	1.6% 2/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.7% 1/60	0.79% 1/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm malignant	0.00% 0/60	0.79% 1/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.7% 1/60	0.00% 0/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/60	0.79% 1/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	1.7% 1/60	0.00% 0/127
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/60	0.79% 1/127
Gastrointestinal disorders Colitis ulcerative	0.00% 0/60	0.79% 1/127
Gastrointestinal disorders Colonic polyp	0.00% 0/60	0.79% 1/127
Gastrointestinal disorders Inguinal hernia	1.7% 1/60	0.00% 0/127
Metabolism and nutrition disorders Dehydration	0.00% 0/60	1.6% 2/127
Cardiac disorders Ventricular tachycardia	1.7% 1/60	0.00% 0/127
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/60	0.79% 1/127
Eye disorders Age-related macular degeneration	1.7% 1/60	0.00% 0/127
General disorders Multi-organ failure	0.00% 0/60	0.79% 1/127
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/60	0.79% 1/127
Nervous system disorders Optic neuritis	0.00% 0/60	0.79% 1/127

Other adverse events

Other adverse events
Measure	FF/VI 100/25 µg n=60 participants at risk Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=127 participants at risk Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Infections and infestations Nasopharyngitis	30.0% 18/60	42.5% 54/127
Infections and infestations Bronchitis	8.3% 5/60	6.3% 8/127
Infections and infestations Pharyngitis	6.7% 4/60	5.5% 7/127
Infections and infestations Oral candidiasis	0.00% 0/60	7.9% 10/127
Infections and infestations Pneumonia	1.7% 1/60	6.3% 8/127
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	13.3% 8/60	9.4% 12/127
Respiratory, thoracic and mediastinal disorders Dysphonia	10.0% 6/60	6.3% 8/127
Musculoskeletal and connective tissue disorders Back pain	6.7% 4/60	10.2% 13/127
Skin and subcutaneous tissue disorders Eczema	6.7% 4/60	4.7% 6/127
Gastrointestinal disorders Constipation	5.0% 3/60	3.1% 4/127

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	FF/VI 100/25 µg n=58 Participants Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.	FF/VI 200/25 µg n=125 Participants Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 16, n=57, 116	1.2 Millimeters of Mercury (mmHg) Standard Deviation 12.94	0.9 Millimeters of Mercury (mmHg) Standard Deviation 14.18
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 24, n=53, 115	-0.3 Millimeters of Mercury (mmHg) Standard Deviation 13.20	-1.3 Millimeters of Mercury (mmHg) Standard Deviation 14.63
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 32, n=53, 112	-1.8 Millimeters of Mercury (mmHg) Standard Deviation 12.77	-5.0 Millimeters of Mercury (mmHg) Standard Deviation 14.76
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 40, n=50, 107	-3.0 Millimeters of Mercury (mmHg) Standard Deviation 13.65	-3.9 Millimeters of Mercury (mmHg) Standard Deviation 14.06
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 52, n=49, 106	3.7 Millimeters of Mercury (mmHg) Standard Deviation 15.43	0.7 Millimeters of Mercury (mmHg) Standard Deviation 15.16
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 12, n=57, 119	0.7 Millimeters of Mercury (mmHg) Standard Deviation 8.09	0.8 Millimeters of Mercury (mmHg) Standard Deviation 10.76
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 16, n=57, 116	0.4 Millimeters of Mercury (mmHg) Standard Deviation 9.69	0.7 Millimeters of Mercury (mmHg) Standard Deviation 10.76
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 24, n=53, 115	0.3 Millimeters of Mercury (mmHg) Standard Deviation 9.30	-1.1 Millimeters of Mercury (mmHg) Standard Deviation 11.71
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 52, n=49, 106	1.2 Millimeters of Mercury (mmHg) Standard Deviation 12.43	0.8 Millimeters of Mercury (mmHg) Standard Deviation 10.77
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 24/WD, n=56, 125	0.2 Millimeters of Mercury (mmHg) Standard Deviation 9.34	-1.2 Millimeters of Mercury (mmHg) Standard Deviation 11.42
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 52/WD, n=56, 123	0.8 Millimeters of Mercury (mmHg) Standard Deviation 11.97	0.7 Millimeters of Mercury (mmHg) Standard Deviation 11.29
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 4, n=58, 124	4.3 Millimeters of Mercury (mmHg) Standard Deviation 12.05	1.2 Millimeters of Mercury (mmHg) Standard Deviation 12.47
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SPB, Week 8, n=58, 123	2.5 Millimeters of Mercury (mmHg) Standard Deviation 11.97	0.4 Millimeters of Mercury (mmHg) Standard Deviation 13.33
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SPB, Week 12, n=57, 119	2.7 Millimeters of Mercury (mmHg) Standard Deviation 14.88	1.2 Millimeters of Mercury (mmHg) Standard Deviation 14.00
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 24/WD, n=56, 125	-0.9 Millimeters of Mercury (mmHg) Standard Deviation 13.73	-1.1 Millimeters of Mercury (mmHg) Standard Deviation 14.48
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD SBP, Week 52/WD, n=56, 123	2.4 Millimeters of Mercury (mmHg) Standard Deviation 15.72	1.1 Millimeters of Mercury (mmHg) Standard Deviation 15.82
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 4, n=58, 124	3.3 Millimeters of Mercury (mmHg) Standard Deviation 9.07	0.9 Millimeters of Mercury (mmHg) Standard Deviation 10.13
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 8, n=58, 123	0.1 Millimeters of Mercury (mmHg) Standard Deviation 8.48	1.0 Millimeters of Mercury (mmHg) Standard Deviation 9.55
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 32, n=53, 112	-1.6 Millimeters of Mercury (mmHg) Standard Deviation 8.50	-1.6 Millimeters of Mercury (mmHg) Standard Deviation 11.23
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD DBP, Week 40, n=50, 107	-1.6 Millimeters of Mercury (mmHg) Standard Deviation 8.89	-0.3 Millimeters of Mercury (mmHg) Standard Deviation 11.08