Asthma
Conditions
Keywords
Adolescents, Adults, Asthma, Pharmacokinetics, Pharmacogenetics, GW685698X
Brief summary
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
Detailed description
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy
Interventions
DRUGGW685698X
GW685698X
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects eligible for enrolment in the study must meet all of the following criteria: * Type of Subject: Outpatient * Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only. * 3\. Gender: Male or Eligible Female * To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: * Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject * Implants of levonorgestrel * Injectable progestogen * Oral contraceptive (either combined estrogen/progestin or progestin only) * Any intrauterine device (IUD) with a documented failure rate of less than 1% per year. * Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days). * Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). * NB: For German sites, female subjects must use a method of birth control other than the double barrier method. * The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds) * Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7. * Asthma Diagnosis: Asthma as defined by the National Institutes of Health \[National Institutes of Health, 2007\]. * Severity of Disease: A best FEV1 of 40%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period. * Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution during the screening period. Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests. * Current Anti-Asthma Therapy: Subjects must have been using a inhaled corticosteroid for at least 8 weeks prior to Visit 1 and maintained on a stable dose of inhaled corticosteroids for four weeks prior to Visit 1 at one of the following doses: \[fluticasone propionate MDI CFC/HFA \>176 ≤ 440mcg exactuator or \> 200 ≤500mcg ex valve\]; \[fluticasone propionate DPI \> 200≤500mcg\]; \[beclomethasone dipropionate DPI \> 420 ≤ 840mcg exactuator or \> 500 ≤ 1000mcg ex-valve\]; \[beclomethasone dipropionate HFA Qvar \> 160 ≤ 480mcg exactuator or \> 200 ≤ 500mcg ex-valve\]; \[budesonide DPI MDI \>400 ≤1200mcg\]; \[flunisolide \> 1000 ≤ 2000mcg\]; \[triamcinolone acetonide \>1000 ≤1600mcg\]; \[mometasone furoate DPI \>200 ≤ 440mcg\]; \[ciclesonide MDI HFA \>160 mcg ≤ 320mcg ex-actuator dose / \>200mcg ≤ 400mcg ex-valve dose} * Short- Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits. * Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. * Compliance: Subjects must be able to comply with completion of the Daily Diary (includes paper medical conditions diary). * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Inclusion Criteria for Randomization At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 3: 1. Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal. 2. Any combination of the daily asthma symptom scores (day-time plus night-time) of ≥1 or albuterol/salbutamol use on at least 4 of the last 7 consecutive days of the run-in period (immediately preceding Visit 3).
Exclusion criteria
* History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. * Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and 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. * Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1. * Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). 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. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary artery disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension, hematological, hepatic, or renal disease, current malignancy, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse. * Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1. * Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1. * Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate). * Milk Protein Allergy: History of severe milk protein allergy. * Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period. * Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation. * Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco). * Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. * Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1. * Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | Baseline and Week 8 | Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | From Baseline up to Week 8 | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group. |
| Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | From Baseline up to Week 8 | Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group. |
| Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | From Baseline up to Week 8 | The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group. |
| Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | From the first dose of the study medication up to Week 8/Early Withdrawal | The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed. |
| Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | From the first dose of the study medication up to Week 8/Early Withdrawal | An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (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; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=3%) and SAEs. |
| Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | From Baseline up to Week 8/Early Withdrawal | A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed. |
| Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1). |
| Hematocrit at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Hemoglobin at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Platelet Count and White Blood Cell Count at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | From Baseline up to Week 8 | PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group. |
| Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1). |
| Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | Baseline and Week 8/Early Withdrawal | 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 Cells (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; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1). |
| Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline and Week 8/Early Withdrawal | Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. |
| Urine pH at Baseline and Week 8/Early Withdrawal | Baseline and Week 8/Early Withdrawal | Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline and Week 8 | A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | Baseline and Week 8 | Change from Baseline was calculated as the Week 8 value minus the Baseline value. |
| Change From Baseline in Heart Rate at Week 8 | Baseline and Week 8 | Change from Baseline was calculated as the Week 8 value minus the Baseline value. |
| Red Blood Cell Count at Baseline and Week 8 | Baseline and Week 8 | Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1). |
Countries
Australia, Bulgaria, Canada, Chile, Czechia, Estonia, France, Germany, Mexico, Netherlands, Peru, Poland, Russia, South Africa, Thailand, United States
Participant flow
Pre-assignment details
Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1175 par. were screened, and 627 par. were randomized, out of which 622 par. received at least one dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 103 |
| GW685698X 200 µg OD Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 99 |
| GW685698X 400 µg OD Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 101 |
| GW685698X 600 µg OD Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 107 |
| GW685698X 800 µg OD Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 102 |
| FP 500 µg BID Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 110 |
| Total | 622 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 0 | 1 | 0 | 4 |
| Overall Study | Lack of Efficacy | 34 | 11 | 6 | 11 | 12 | 8 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 3 | 1 |
Baseline characteristics
| Characteristic | GW685698X 200 µg OD | GW685698X 400 µg OD | GW685698X 600 µg OD | Placebo | GW685698X 800 µg OD | FP 500 µg BID | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.7 Years STANDARD_DEVIATION 15.02 | 47.2 Years STANDARD_DEVIATION 14.39 | 45.7 Years STANDARD_DEVIATION 14.38 | 47.2 Years STANDARD_DEVIATION 14.03 | 46.6 Years STANDARD_DEVIATION 14.09 | 46.1 Years STANDARD_DEVIATION 13.86 | 46.4 Years STANDARD_DEVIATION 14.25 |
| Race/Ethnicity, Customized African American/African Heritage (HER) | 3 participants | 3 participants | 4 participants | 2 participants | 4 participants | 4 participants | 20 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 participants | 5 participants | 8 participants | 6 participants | 5 participants | 7 participants | 38 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native & Asian & White | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native & White | 5 participants | 6 participants | 7 participants | 6 participants | 6 participants | 8 participants | 38 participants |
| Race/Ethnicity, Customized Central/South Asian HER | 3 participants | 1 participants | 4 participants | 2 participants | 1 participants | 1 participants | 12 participants |
| Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER | 6 participants | 6 participants | 7 participants | 4 participants | 6 participants | 6 participants | 35 participants |
| Race/Ethnicity, Customized Missing | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 74 participants | 80 participants | 77 participants | 83 participants | 80 participants | 83 participants | 477 participants |
| Sex: Female, Male Female | 63 Participants | 62 Participants | 67 Participants | 64 Participants | 63 Participants | 68 Participants | 387 Participants |
| Sex: Female, Male Male | 36 Participants | 39 Participants | 40 Participants | 39 Participants | 39 Participants | 42 Participants | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 103 | 18 / 99 | 21 / 101 | 21 / 107 | 26 / 102 | 21 / 110 |
| serious Total, serious adverse events | 1 / 103 | 2 / 99 | 0 / 101 | 1 / 107 | 0 / 102 | 2 / 110 |
Outcome results
Primary
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Time frame: Baseline and Week 8
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | -0.043 Liters | Standard Error 0.0338 |
| GW685698X 200 µg OD | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | 0.232 Liters | Standard Error 0.0347 |
| GW685698X 400 µg OD | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | 0.229 Liters | Standard Error 0.0342 |
| GW685698X 600 µg OD | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | 0.221 Liters | Standard Error 0.0332 |
| GW685698X 800 µg OD | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | 0.182 Liters | Standard Error 0.0342 |
| FP 500 µg BID | Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 | 0.155 Liters | Standard Error 0.0332 |
p-value: <0.00195% CI: [0.18, 0.37]ANCOVA
p-value: <0.00195% CI: [0.178, 0.367]ANCOVA
p-value: <0.00195% CI: [0.171, 0.357]ANCOVA
p-value: <0.00195% CI: [0.131, 0.32]ANCOVA
p-value: <0.00195% CI: [0.105, 0.291]ANCOVA
Secondary
24-hour Urinary Cortisol Excretion at Baseline and Week 8
A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.
Time frame: Baseline and Week 8
Population: Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 52.55 Nanomoles per 24 hours (nmol/24 hours) |
| Placebo | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 51.79 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 200 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 66.00 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 200 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 69.40 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 400 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 55.19 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 400 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 54.65 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 600 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 49.80 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 600 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 67.50 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 800 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 22.99 Nanomoles per 24 hours (nmol/24 hours) |
| GW685698X 800 µg OD | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 51.30 Nanomoles per 24 hours (nmol/24 hours) |
| FP 500 µg BID | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Baseline | 70.12 Nanomoles per 24 hours (nmol/24 hours) |
| FP 500 µg BID | 24-hour Urinary Cortisol Excretion at Baseline and Week 8 | Week 8 | 62.35 Nanomoles per 24 hours (nmol/24 hours) |
Secondary
Change From Baseline in Heart Rate at Week 8
Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate at Week 8 | 0.7 Beats per minute | Standard Deviation 8.07 |
| GW685698X 200 µg OD | Change From Baseline in Heart Rate at Week 8 | -0.8 Beats per minute | Standard Deviation 9.4 |
| GW685698X 400 µg OD | Change From Baseline in Heart Rate at Week 8 | 0.2 Beats per minute | Standard Deviation 8.89 |
| GW685698X 600 µg OD | Change From Baseline in Heart Rate at Week 8 | -0.1 Beats per minute | Standard Deviation 8.7 |
| GW685698X 800 µg OD | Change From Baseline in Heart Rate at Week 8 | -0.4 Beats per minute | Standard Deviation 8.24 |
| FP 500 µg BID | Change From Baseline in Heart Rate at Week 8 | -0.0 Beats per minute | Standard Deviation 8.6 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8
Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 11.17 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 8.28 |
| GW685698X 200 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.96 |
| GW685698X 200 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 8.36 |
| GW685698X 400 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 9.56 |
| GW685698X 400 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 8.37 |
| GW685698X 600 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 11.07 |
| GW685698X 600 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 7.74 |
| GW685698X 800 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 11.57 |
| GW685698X 800 µg OD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 8.72 |
| FP 500 µg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | SBP | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 11.32 |
| FP 500 µg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 | DBP | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 9.48 |
Secondary
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8
Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 36.4 International units per liter (IU/L) | Standard Deviation 37.07 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 24.1 International units per liter (IU/L) | Standard Deviation 20.87 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 22.4 International units per liter (IU/L) | Standard Deviation 12.52 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 33.0 International units per liter (IU/L) | Standard Deviation 26.34 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 23.7 International units per liter (IU/L) | Standard Deviation 19.99 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 75.1 International units per liter (IU/L) | Standard Deviation 21.38 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 160.4 International units per liter (IU/L) | Standard Deviation 43.44 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 74.7 International units per liter (IU/L) | Standard Deviation 21.34 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 158.2 International units per liter (IU/L) | Standard Deviation 26.1 |
| Placebo | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 21.6 International units per liter (IU/L) | Standard Deviation 6.45 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 21.0 International units per liter (IU/L) | Standard Deviation 10.02 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 162.0 International units per liter (IU/L) | Standard Deviation 27.64 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 21.6 International units per liter (IU/L) | Standard Deviation 7.11 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 21.6 International units per liter (IU/L) | Standard Deviation 8.39 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 80.2 International units per liter (IU/L) | Standard Deviation 41.24 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 159.0 International units per liter (IU/L) | Standard Deviation 27.52 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 80.4 International units per liter (IU/L) | Standard Deviation 54.47 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 20.2 International units per liter (IU/L) | Standard Deviation 11.31 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 36.8 International units per liter (IU/L) | Standard Deviation 39.79 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 32.7 International units per liter (IU/L) | Standard Deviation 22.5 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 40.4 International units per liter (IU/L) | Standard Deviation 44.86 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 21.6 International units per liter (IU/L) | Standard Deviation 14.43 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 163.5 International units per liter (IU/L) | Standard Deviation 35.16 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 163.6 International units per liter (IU/L) | Standard Deviation 37 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 90.9 International units per liter (IU/L) | Standard Deviation 54.98 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 40.6 International units per liter (IU/L) | Standard Deviation 70.55 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 23.9 International units per liter (IU/L) | Standard Deviation 15.07 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 22.0 International units per liter (IU/L) | Standard Deviation 11.41 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 86.6 International units per liter (IU/L) | Standard Deviation 42.66 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 23.7 International units per liter (IU/L) | Standard Deviation 10.46 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 74.5 International units per liter (IU/L) | Standard Deviation 26.54 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 47.4 International units per liter (IU/L) | Standard Deviation 167.46 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 23.5 International units per liter (IU/L) | Standard Deviation 18.89 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 20.4 International units per liter (IU/L) | Standard Deviation 12.33 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 77.1 International units per liter (IU/L) | Standard Deviation 38.35 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 42.3 International units per liter (IU/L) | Standard Deviation 109.34 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 158.7 International units per liter (IU/L) | Standard Deviation 30.24 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 164.6 International units per liter (IU/L) | Standard Deviation 35.8 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 23.3 International units per liter (IU/L) | Standard Deviation 20.15 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 22.1 International units per liter (IU/L) | Standard Deviation 17.12 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 161.6 International units per liter (IU/L) | Standard Deviation 31.49 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 22.0 International units per liter (IU/L) | Standard Deviation 12.14 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 73.9 International units per liter (IU/L) | Standard Deviation 31.02 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 70.6 International units per liter (IU/L) | Standard Deviation 26.33 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 22.7 International units per liter (IU/L) | Standard Deviation 8.42 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 22.0 International units per liter (IU/L) | Standard Deviation 9.25 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 31.2 International units per liter (IU/L) | Standard Deviation 22.88 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 34.1 International units per liter (IU/L) | Standard Deviation 28.31 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 23.1 International units per liter (IU/L) | Standard Deviation 14.71 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 170.6 International units per liter (IU/L) | Standard Deviation 33.92 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, W8, n=66, 78, 91, 89, 86, 96 | 77.2 International units per liter (IU/L) | Standard Deviation 28.25 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALP, BL, n=101, 97, 101, 107, 100, 109 | 76.7 International units per liter (IU/L) | Standard Deviation 32.97 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, W8, n=66, 78, 91, 89, 85, 96 | 164.0 International units per liter (IU/L) | Standard Deviation 27.59 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | LDH, BL, n=101, 97, 100, 106, 101, 108 | 160.6 International units per liter (IU/L) | Standard Deviation 24.97 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, W8, n=66, 79, 91, 90, 86, 96 | 20.7 International units per liter (IU/L) | Standard Deviation 14.56 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | ALT, BL, n=101, 97, 101, 107, 101, 109 | 20.5 International units per liter (IU/L) | Standard Deviation 13.26 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, BL, n=101, 97, 101, 107, 101, 109 | 28.2 International units per liter (IU/L) | Standard Deviation 20.5 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, W8, n=66, 78, 91, 89, 85, 96 | 21.4 International units per liter (IU/L) | Standard Deviation 8.61 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | GGT, W8, n=66, 79, 91, 90, 86, 96 | 29.2 International units per liter (IU/L) | Standard Deviation 20.01 |
| FP 500 µg BID | Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 | AST, BL, n=101, 97, 100, 106, 101, 108 | 21.9 International units per liter (IU/L) | Standard Deviation 11.34 |
Secondary
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.5 Grams per liter (g/L) | Standard Deviation 2.66 |
| Placebo | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 72.0 Grams per liter (g/L) | Standard Deviation 4.21 |
| Placebo | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 72.7 Grams per liter (g/L) | Standard Deviation 3.82 |
| Placebo | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 44.6 Grams per liter (g/L) | Standard Deviation 2.36 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 72.6 Grams per liter (g/L) | Standard Deviation 3.67 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.8 Grams per liter (g/L) | Standard Deviation 3.27 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 73.4 Grams per liter (g/L) | Standard Deviation 3.9 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 44.9 Grams per liter (g/L) | Standard Deviation 3.11 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 45.1 Grams per liter (g/L) | Standard Deviation 2.91 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.6 Grams per liter (g/L) | Standard Deviation 3.32 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 72.7 Grams per liter (g/L) | Standard Deviation 4.54 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 73.2 Grams per liter (g/L) | Standard Deviation 4.15 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.0 Grams per liter (g/L) | Standard Deviation 3.28 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 72.2 Grams per liter (g/L) | Standard Deviation 4.2 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 73.3 Grams per liter (g/L) | Standard Deviation 4.22 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 44.3 Grams per liter (g/L) | Standard Deviation 3.27 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.1 Grams per liter (g/L) | Standard Deviation 3.38 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 73.1 Grams per liter (g/L) | Standard Deviation 4.8 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 44.8 Grams per liter (g/L) | Standard Deviation 3.49 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 72.0 Grams per liter (g/L) | Standard Deviation 4.39 |
| FP 500 µg BID | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, W8, n=66, 79, 91, 90, 86, 96 | 71.9 Grams per liter (g/L) | Standard Deviation 4.34 |
| FP 500 µg BID | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, BL, n=101, 97, 101, 107, 101, 109 | 44.9 Grams per liter (g/L) | Standard Deviation 2.96 |
| FP 500 µg BID | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Albumin, W8, n=66, 79, 91, 90, 86, 96 | 44.6 Grams per liter (g/L) | Standard Deviation 3.07 |
| FP 500 µg BID | Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 | Total protein, BL, n=101, 97, 101, 107, 101, 109 | 72.5 Grams per liter (g/L) | Standard Deviation 3.85 |
Secondary
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8
Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 0.81 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.7 Millimoles per liter (mmol/L) | Standard Deviation 1.68 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 22.7 Millimoles per liter (mmol/L) | Standard Deviation 3.01 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.38 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.5 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 105.0 Millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.04 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 104.8 Millimoles per liter (mmol/L) | Standard Deviation 2.45 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.16 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.36 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.8 Millimoles per liter (mmol/L) | Standard Deviation 1.93 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.38 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 1.57 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.07 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 23.2 Millimoles per liter (mmol/L) | Standard Deviation 2.45 |
| Placebo | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.1 Millimoles per liter (mmol/L) | Standard Deviation 0.18 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 22.7 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1.81 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.17 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.1 Millimoles per liter (mmol/L) | Standard Deviation 0.18 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.11 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.5 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 22.9 Millimoles per liter (mmol/L) | Standard Deviation 2.75 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.49 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.3 Millimoles per liter (mmol/L) | Standard Deviation 2.17 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 104.4 Millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 104.4 Millimoles per liter (mmol/L) | Standard Deviation 2.46 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.4 Millimoles per liter (mmol/L) | Standard Deviation 1.92 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1.11 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.09 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.3 Millimoles per liter (mmol/L) | Standard Deviation 0.47 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.4 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.22 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.7 Millimoles per liter (mmol/L) | Standard Deviation 1.37 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1.13 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 3.24 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.41 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.27 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 23.3 Millimoles per liter (mmol/L) | Standard Deviation 2.39 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.07 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.4 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 104.1 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.3 Millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 23.5 Millimoles per liter (mmol/L) | Standard Deviation 2.71 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.4 Millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.15 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 103.9 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.8 Millimoles per liter (mmol/L) | Standard Deviation 1.72 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.51 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.11 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 22.6 Millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 22.6 Millimoles per liter (mmol/L) | Standard Deviation 2.56 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 104.3 Millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 104.3 Millimoles per liter (mmol/L) | Standard Deviation 2.46 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1.21 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.24 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.14 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.19 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.19 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.16 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.41 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.38 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.1 Millimoles per liter (mmol/L) | Standard Deviation 1.93 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.1 Millimoles per liter (mmol/L) | Standard Deviation 1.99 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.0 Millimoles per liter (mmol/L) | Standard Deviation 1.34 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.45 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 104.4 Millimoles per liter (mmol/L) | Standard Deviation 2.25 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 23.3 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.32 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.4 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.73 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 1.03 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 23.1 Millimoles per liter (mmol/L) | Standard Deviation 2.56 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 104.1 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.6 Millimoles per liter (mmol/L) | Standard Deviation 1.35 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 1.52 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.19 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.91 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.1 Millimoles per liter (mmol/L) | Standard Deviation 1.64 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.17 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.5 Millimoles per liter (mmol/L) | Standard Deviation 1.15 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, W8, n=66, 79, 91, 90, 86, 96 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 0.16 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, W8, n=66, 79, 91, 90, 86, 96 | 5.2 Millimoles per liter (mmol/L) | Standard Deviation 1.17 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, BL, n=101, 97, 100, 106, 101, 108 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.41 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Cholesterol, BL, n=101, 97, 101, 107, 101, 109 | 5.1 Millimoles per liter (mmol/L) | Standard Deviation 1.08 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, BL, n=101, 97, 100, 106, 101, 108 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Potassium, W8, n=66, 78, 91, 89, 85, 96 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 0.36 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, W8, n=66, 79, 91, 90, 86, 96 | 104.9 Millimoles per liter (mmol/L) | Standard Deviation 2.79 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Chloride, BL, n=101, 97, 101, 107, 101, 109 | 105.0 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, BL, n=101, 97, 101, 107, 101, 109 | 140.8 Millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, W8, n=66, 78, 91, 89, 85, 96 | 22.9 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, W8, n=66, 79, 91, 90, 86, 96 | 5.6 Millimoles per liter (mmol/L) | Standard Deviation 1.55 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Sodium, W8, n=66, 79, 91, 90, 86, 96 | 140.6 Millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | CO2/BI, BL, n=101, 97, 100, 106, 101, 108 | 23.2 Millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Calcium, W8, n=66, 78, 91, 89, 85, 96 | 2.3 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | PI, BL, n=101, 97, 101, 107, 101, 109 | 1.1 Millimoles per liter (mmol/L) | Standard Deviation 0.18 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, W8, n=66, 78, 91, 90, 86, 96 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 1.16 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Urea, BL, n=101, 97, 101, 107, 101, 109 | 5.4 Millimoles per liter (mmol/L) | Standard Deviation 1.63 |
| FP 500 µg BID | Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 | Glucose, BL, n=101, 97, 101, 107 | 5.3 Millimoles per liter (mmol/L) | Standard Deviation 0.91 |
Secondary
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8
Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 2.0 Micromoles per liter (µmol/L) | Standard Deviation 0.92 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 83.2 Micromoles per liter (µmol/L) | Standard Deviation 15.84 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 8.3 Micromoles per liter (µmol/L) | Standard Deviation 3.68 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 9.4 Micromoles per liter (µmol/L) | Standard Deviation 4.67 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 323.3 Micromoles per liter (µmol/L) | Standard Deviation 102.51 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 1.7 Micromoles per liter (µmol/L) | Standard Deviation 0.75 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 84.4 Micromoles per liter (µmol/L) | Standard Deviation 14.89 |
| Placebo | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 326.2 Micromoles per liter (µmol/L) | Standard Deviation 104.11 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 79.9 Micromoles per liter (µmol/L) | Standard Deviation 12.4 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 79.8 Micromoles per liter (µmol/L) | Standard Deviation 14.17 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 2.0 Micromoles per liter (µmol/L) | Standard Deviation 1.08 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 1.8 Micromoles per liter (µmol/L) | Standard Deviation 0.91 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 9.9 Micromoles per liter (µmol/L) | Standard Deviation 4.87 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 9.0 Micromoles per liter (µmol/L) | Standard Deviation 4.44 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 326.1 Micromoles per liter (µmol/L) | Standard Deviation 75.18 |
| GW685698X 200 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 318.5 Micromoles per liter (µmol/L) | Standard Deviation 75.93 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 2.1 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 9.8 Micromoles per liter (µmol/L) | Standard Deviation 5.1 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 78.6 Micromoles per liter (µmol/L) | Standard Deviation 15.25 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 319.2 Micromoles per liter (µmol/L) | Standard Deviation 89.12 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 2.1 Micromoles per liter (µmol/L) | Standard Deviation 1.19 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 79.4 Micromoles per liter (µmol/L) | Standard Deviation 15.86 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 330.4 Micromoles per liter (µmol/L) | Standard Deviation 81.69 |
| GW685698X 400 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 9.8 Micromoles per liter (µmol/L) | Standard Deviation 5.19 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 322.1 Micromoles per liter (µmol/L) | Standard Deviation 87.22 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 9.4 Micromoles per liter (µmol/L) | Standard Deviation 5.65 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 305.8 Micromoles per liter (µmol/L) | Standard Deviation 91.04 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 1.9 Micromoles per liter (µmol/L) | Standard Deviation 1.22 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 2.0 Micromoles per liter (µmol/L) | Standard Deviation 1.05 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 78.8 Micromoles per liter (µmol/L) | Standard Deviation 14.12 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 78.7 Micromoles per liter (µmol/L) | Standard Deviation 13.95 |
| GW685698X 600 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 9.7 Micromoles per liter (µmol/L) | Standard Deviation 5 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 81.7 Micromoles per liter (µmol/L) | Standard Deviation 13.87 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 1.7 Micromoles per liter (µmol/L) | Standard Deviation 0.94 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 1.7 Micromoles per liter (µmol/L) | Standard Deviation 0.82 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 8.2 Micromoles per liter (µmol/L) | Standard Deviation 3.31 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 8.6 Micromoles per liter (µmol/L) | Standard Deviation 3.33 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 316.5 Micromoles per liter (µmol/L) | Standard Deviation 92.8 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 330.8 Micromoles per liter (µmol/L) | Standard Deviation 90.07 |
| GW685698X 800 µg OD | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 81.4 Micromoles per liter (µmol/L) | Standard Deviation 13.9 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, W8, n=66, 79, 91, 90, 86, 96 | 9.6 Micromoles per liter (µmol/L) | Standard Deviation 4.76 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, BL, n=101, 97, 101, 107, 101, 109 | 310.6 Micromoles per liter (µmol/L) | Standard Deviation 83.25 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, BL, n=101, 97, 101, 107, 101, 109 | 82.0 Micromoles per liter (µmol/L) | Standard Deviation 18.12 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Creatinine, W8, n=66, 79, 91, 90, 86, 96 | 81.3 Micromoles per liter (µmol/L) | Standard Deviation 18.02 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | TBIL, BL, n=101, 97, 101, 107, 101, 109 | 10.3 Micromoles per liter (µmol/L) | Standard Deviation 5.86 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, W8, n=65, 78, 91, 90, 86, 96 | 2.0 Micromoles per liter (µmol/L) | Standard Deviation 1.2 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | DBIL, BL, n=101, 97, 101, 107, 101, 109 | 2.1 Micromoles per liter (µmol/L) | Standard Deviation 1.38 |
| FP 500 µg BID | Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 | Uric acid, W8, n=66, 79, 91, 90, 86, 96 | 322.7 Micromoles per liter (µmol/L) | Standard Deviation 88.44 |
Secondary
Hematocrit at Baseline and Week 8
Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.43 Proportion of 1 | Standard Deviation 0.04 |
| Placebo | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.43 Proportion of 1 | Standard Deviation 0.039 |
| GW685698X 200 µg OD | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.43 Proportion of 1 | Standard Deviation 0.034 |
| GW685698X 200 µg OD | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.42 Proportion of 1 | Standard Deviation 0.036 |
| GW685698X 400 µg OD | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.42 Proportion of 1 | Standard Deviation 0.035 |
| GW685698X 400 µg OD | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.42 Proportion of 1 | Standard Deviation 0.035 |
| GW685698X 600 µg OD | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.42 Proportion of 1 | Standard Deviation 0.042 |
| GW685698X 600 µg OD | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.42 Proportion of 1 | Standard Deviation 0.042 |
| GW685698X 800 µg OD | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.43 Proportion of 1 | Standard Deviation 0.038 |
| GW685698X 800 µg OD | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.43 Proportion of 1 | Standard Deviation 0.037 |
| FP 500 µg BID | Hematocrit at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 0.42 Proportion of 1 | Standard Deviation 0.043 |
| FP 500 µg BID | Hematocrit at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 0.42 Proportion of 1 | Standard Deviation 0.043 |
Secondary
Hemoglobin at Baseline and Week 8
Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 139.99 Grams per liter (G/L) | Standard Deviation 13.23 |
| Placebo | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 139.63 Grams per liter (G/L) | Standard Deviation 12.359 |
| GW685698X 200 µg OD | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 140.20 Grams per liter (G/L) | Standard Deviation 11.183 |
| GW685698X 200 µg OD | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 137.42 Grams per liter (G/L) | Standard Deviation 11.461 |
| GW685698X 400 µg OD | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 139.35 Grams per liter (G/L) | Standard Deviation 11.577 |
| GW685698X 400 µg OD | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 137.56 Grams per liter (G/L) | Standard Deviation 11.747 |
| GW685698X 600 µg OD | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 138.50 Grams per liter (G/L) | Standard Deviation 14.987 |
| GW685698X 600 µg OD | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 135.81 Grams per liter (G/L) | Standard Deviation 13.847 |
| GW685698X 800 µg OD | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 140.91 Grams per liter (G/L) | Standard Deviation 13.023 |
| GW685698X 800 µg OD | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 140.64 Grams per liter (G/L) | Standard Deviation 12.679 |
| FP 500 µg BID | Hemoglobin at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 138.53 Grams per liter (G/L) | Standard Deviation 14.77 |
| FP 500 µg BID | Hemoglobin at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 137.31 Grams per liter (G/L) | Standard Deviation 14.65 |
Secondary
Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.
Time frame: From Baseline up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | -7.3 Liters per minute | Standard Error 3.32 |
| GW685698X 200 µg OD | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | 19.6 Liters per minute | Standard Error 3.34 |
| GW685698X 400 µg OD | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | 20.9 Liters per minute | Standard Error 3.31 |
| GW685698X 600 µg OD | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | 16.7 Liters per minute | Standard Error 3.22 |
| GW685698X 800 µg OD | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | 20.7 Liters per minute | Standard Error 3.32 |
| FP 500 µg BID | Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period | 16.5 Liters per minute | Standard Error 3.19 |
Secondary
Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.
Time frame: From Baseline up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | -5.1 Liters per minute | Standard Error 3.32 |
| GW685698X 200 µg OD | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | 11.9 Liters per minute | Standard Error 3.32 |
| GW685698X 400 µg OD | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | 14.5 Liters per minute | Standard Error 3.29 |
| GW685698X 600 µg OD | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | 11.7 Liters per minute | Standard Error 3.2 |
| GW685698X 800 µg OD | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | 16.3 Liters per minute | Standard Error 3.3 |
| FP 500 µg BID | Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period | 11.1 Liters per minute | Standard Error 3.17 |
Secondary
Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Time frame: From Baseline up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 3.6 Percentage of rescue-free 24-hr periods | Standard Error 2.75 |
| GW685698X 200 µg OD | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 17.9 Percentage of rescue-free 24-hr periods | Standard Error 2.78 |
| GW685698X 400 µg OD | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 21.1 Percentage of rescue-free 24-hr periods | Standard Error 2.75 |
| GW685698X 600 µg OD | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 17.4 Percentage of rescue-free 24-hr periods | Standard Error 2.67 |
| GW685698X 800 µg OD | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 22.3 Percentage of rescue-free 24-hr periods | Standard Error 2.75 |
| FP 500 µg BID | Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period | 16.7 Percentage of rescue-free 24-hr periods | Standard Error 2.63 |
Secondary
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period
Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Time frame: From Baseline up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 6.4 Percentage of symptom-free 24-hr periods | Standard Error 2.71 |
| GW685698X 200 µg OD | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 20.1 Percentage of symptom-free 24-hr periods | Standard Error 2.74 |
| GW685698X 400 µg OD | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 19.6 Percentage of symptom-free 24-hr periods | Standard Error 2.71 |
| GW685698X 600 µg OD | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 15.1 Percentage of symptom-free 24-hr periods | Standard Error 2.63 |
| GW685698X 800 µg OD | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 18.5 Percentage of symptom-free 24-hr periods | Standard Error 2.71 |
| FP 500 µg BID | Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period | 15.4 Percentage of symptom-free 24-hr periods | Standard Error 2.61 |
Secondary
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (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; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=3%) and SAEs.
Time frame: From the first dose of the study medication up to Week 8/Early Withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 1 participants |
| Placebo | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 23 participants |
| GW685698X 200 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 2 participants |
| GW685698X 200 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 31 participants |
| GW685698X 400 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 34 participants |
| GW685698X 400 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 0 participants |
| GW685698X 600 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 37 participants |
| GW685698X 600 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 1 participants |
| GW685698X 800 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 36 participants |
| GW685698X 800 µg OD | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 0 participants |
| FP 500 µg BID | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any SAE | 2 participants |
| FP 500 µg BID | Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period | Any AE | 39 participants |
Secondary
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis
A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.
Time frame: From Baseline up to Week 8/Early Withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| Placebo | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 103 participants |
| GW685698X 200 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| GW685698X 200 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 99 participants |
| GW685698X 400 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| GW685698X 400 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 101 participants |
| GW685698X 600 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 107 participants |
| GW685698X 600 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| GW685698X 800 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| GW685698X 800 µg OD | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 102 participants |
| FP 500 µg BID | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | Clinical evidence | 0 participants |
| FP 500 µg BID | Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis | No clinical evidence | 110 participants |
Secondary
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal
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 Cells (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; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 63 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 97 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 87 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 58 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 6 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 2 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 6 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 56 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 6 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 90 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 7 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 7 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 3 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 63 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 57 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 88 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 6 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 93 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 7 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| Placebo | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 78 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 77 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 11 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 84 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 95 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 78 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 97 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 87 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 71 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 5 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 9 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 9 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 69 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 0 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 200 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 69 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 81 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 83 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 75 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 5 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 75 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 93 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 83 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 93 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 86 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 5 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 80 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 8 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 77 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 6 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 400 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 6 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 101 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 6 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 71 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 8 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 86 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 7 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 3 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 88 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 5 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 6 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 77 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 6 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 72 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 9 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 93 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 85 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 99 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 0 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 88 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 600 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 5 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 85 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 7 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 78 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 7 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 83 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 94 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 71 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 5 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 4 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 5 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 5 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 65 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 6 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 91 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 72 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 83 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 78 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 4 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| GW685698X 800 µg OD | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 5 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, EW, n=7, 0, 1, 4, 80, 92 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103 | 81 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, EW, n=7, 0, 1, 4, 80, 92 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92 | 8 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, BL, n=97, 98, 96, 102, 95, 103 | 82 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, 1+, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, BL, n=97, 98, 96, 102, 95, 103 | 17 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Trace, W8, n=65, 79, 88, 90, 80, 92 | 9 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, BL, n=97, 98, 96, 102, 95, 103 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, BL, n=97, 98, 96, 102, 95, 103 | 101 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 1+, W8, n=65, 79, 88, 90, 80, 92 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, Neg, W8, n=65, 79, 88, 90, 80, 92 | 90 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, BL, n=97, 98, 96, 102, 95, 103 | 95 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, BL, n=97, 98, 96, 102, 95, 103 | 99 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, W8, n=65, 79, 88, 90, 80, 92 | 87 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 2+, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 3+, W8, n=65, 79, 88, 90, 80, 92 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Large, BL, n=97, 98, 96, 102, 95, 103 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Small, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103 | 11 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, W8, n=65, 79, 88, 90, 80, 92 | 81 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Small, EW, n=7, 0, 1, 4, 5, 4 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, 1+, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Trace, W8, n=65, 79, 88, 90, 80, 92 | 7 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92 | 5 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Large, W8, n=65, 79, 88, 90, 80, 92 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UOB, Neg, W8, n=65, 79, 88, 90, 80, 92 | 79 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UP, Neg, EW, n=7, 0, 1, 4, 5, 4 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UK, Trace, BL, n=97, 98, 96, 102, 95, 103 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92 | 71 participants |
| FP 500 µg BID | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal | UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103 | 3 participants |
Secondary
Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period
The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
Time frame: From the first dose of the study medication up to Week 8/Early Withdrawal
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 34 participants |
| GW685698X 200 µg OD | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 11 participants |
| GW685698X 400 µg OD | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 6 participants |
| GW685698X 600 µg OD | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 11 participants |
| GW685698X 800 µg OD | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 12 participants |
| FP 500 µg BID | Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period | 8 participants |
Secondary
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 5.03 Percentage in the blood | Standard Deviation 2.337 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 3.92 Percentage in the blood | Standard Deviation 2.835 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.31 Percentage in the blood | Standard Deviation 0.211 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.38 Percentage in the blood | Standard Deviation 0.191 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 58.22 Percentage in the blood | Standard Deviation 8.02 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 30.87 Percentage in the blood | Standard Deviation 8.332 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 32.23 Percentage in the blood | Standard Deviation 7.231 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 59.78 Percentage in the blood | Standard Deviation 9.101 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 4.21 Percentage in the blood | Standard Deviation 3.241 |
| Placebo | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 5.07 Percentage in the blood | Standard Deviation 1.885 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 4.11 Percentage in the blood | Standard Deviation 3.024 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 58.45 Percentage in the blood | Standard Deviation 9.166 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 60.95 Percentage in the blood | Standard Deviation 7.819 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 3.54 Percentage in the blood | Standard Deviation 2.784 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 32.31 Percentage in the blood | Standard Deviation 8.344 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.35 Percentage in the blood | Standard Deviation 0.199 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 4.75 Percentage in the blood | Standard Deviation 1.765 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 4.53 Percentage in the blood | Standard Deviation 2.025 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 30.64 Percentage in the blood | Standard Deviation 7.046 |
| GW685698X 200 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.38 Percentage in the blood | Standard Deviation 0.315 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 5.23 Percentage in the blood | Standard Deviation 2.58 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 57.08 Percentage in the blood | Standard Deviation 10.168 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 4.82 Percentage in the blood | Standard Deviation 2.087 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.35 Percentage in the blood | Standard Deviation 0.252 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 61.87 Percentage in the blood | Standard Deviation 9.175 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.28 Percentage in the blood | Standard Deviation 0.172 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 3.70 Percentage in the blood | Standard Deviation 2.942 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 33.48 Percentage in the blood | Standard Deviation 9.299 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 2.76 Percentage in the blood | Standard Deviation 1.943 |
| GW685698X 400 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 30.28 Percentage in the blood | Standard Deviation 8.734 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 2.94 Percentage in the blood | Standard Deviation 3.395 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 4.34 Percentage in the blood | Standard Deviation 3.148 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 64.67 Percentage in the blood | Standard Deviation 10.031 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 4.89 Percentage in the blood | Standard Deviation 1.896 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 27.64 Percentage in the blood | Standard Deviation 9.216 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.26 Percentage in the blood | Standard Deviation 0.164 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 58.41 Percentage in the blood | Standard Deviation 8.589 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.34 Percentage in the blood | Standard Deviation 0.306 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 4.50 Percentage in the blood | Standard Deviation 2.188 |
| GW685698X 600 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 32.03 Percentage in the blood | Standard Deviation 7.813 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 57.33 Percentage in the blood | Standard Deviation 8.627 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 2.14 Percentage in the blood | Standard Deviation 2.076 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.36 Percentage in the blood | Standard Deviation 0.22 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.31 Percentage in the blood | Standard Deviation 0.175 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 3.74 Percentage in the blood | Standard Deviation 2.543 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 33.33 Percentage in the blood | Standard Deviation 7.99 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 29.50 Percentage in the blood | Standard Deviation 9.763 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 5.19 Percentage in the blood | Standard Deviation 2.384 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 4.64 Percentage in the blood | Standard Deviation 2.224 |
| GW685698X 800 µg OD | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 63.41 Percentage in the blood | Standard Deviation 10.926 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, BL, n=96, 98, 96, 101, 96, 104 | 5.06 Percentage in the blood | Standard Deviation 1.989 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93 | 29.23 Percentage in the blood | Standard Deviation 8.205 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, W 8, n=64, 78, 86, 88, 80, 93 | 0.30 Percentage in the blood | Standard Deviation 0.159 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, BL, n=96, 98, 96, 101, 96, 104 | 60.96 Percentage in the blood | Standard Deviation 10.096 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Lymphocytes, BL, n=96, 98, 96, 101, 96, 104 | 30.13 Percentage in the blood | Standard Deviation 8.938 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, BL, n=96, 98, 96, 101, 96, 104 | 3.50 Percentage in the blood | Standard Deviation 2.675 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Basophils, BL, n=96, 98, 96, 101, 96, 104 | 0.34 Percentage in the blood | Standard Deviation 0.181 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Eosinophils, W 8, n=64, 78, 86, 88, 80, 93 | 3.31 Percentage in the blood | Standard Deviation 2.815 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93 | 62.19 Percentage in the blood | Standard Deviation 9.128 |
| FP 500 µg BID | Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 | Monocytes, W 8, n=64, 78, 86, 88, 80, 93 | 4.97 Percentage in the blood | Standard Deviation 2.15 |
Secondary
Platelet Count and White Blood Cell Count at Baseline and Week 8
Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 7.84 10^9 cells per liter (GI/L) | Standard Deviation 1.944 |
| Placebo | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 8.16 10^9 cells per liter (GI/L) | Standard Deviation 2.182 |
| Placebo | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 265.86 10^9 cells per liter (GI/L) | Standard Deviation 55.155 |
| Placebo | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 275.76 10^9 cells per liter (GI/L) | Standard Deviation 58.949 |
| GW685698X 200 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 285.62 10^9 cells per liter (GI/L) | Standard Deviation 66.487 |
| GW685698X 200 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 7.97 10^9 cells per liter (GI/L) | Standard Deviation 1.671 |
| GW685698X 200 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 7.77 10^9 cells per liter (GI/L) | Standard Deviation 2.016 |
| GW685698X 200 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 281.46 10^9 cells per liter (GI/L) | Standard Deviation 74.55 |
| GW685698X 400 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 270.77 10^9 cells per liter (GI/L) | Standard Deviation 50.491 |
| GW685698X 400 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 270.32 10^9 cells per liter (GI/L) | Standard Deviation 50.756 |
| GW685698X 400 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 8.38 10^9 cells per liter (GI/L) | Standard Deviation 2.416 |
| GW685698X 400 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 8.01 10^9 cells per liter (GI/L) | Standard Deviation 2.199 |
| GW685698X 600 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 9.10 10^9 cells per liter (GI/L) | Standard Deviation 2.134 |
| GW685698X 600 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 275.62 10^9 cells per liter (GI/L) | Standard Deviation 56.811 |
| GW685698X 600 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 291.36 10^9 cells per liter (GI/L) | Standard Deviation 63.65 |
| GW685698X 600 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 8.18 10^9 cells per liter (GI/L) | Standard Deviation 1.807 |
| GW685698X 800 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 269.09 10^9 cells per liter (GI/L) | Standard Deviation 61.89 |
| GW685698X 800 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 280.78 10^9 cells per liter (GI/L) | Standard Deviation 65.044 |
| GW685698X 800 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 7.91 10^9 cells per liter (GI/L) | Standard Deviation 1.853 |
| GW685698X 800 µg OD | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 8.90 10^9 cells per liter (GI/L) | Standard Deviation 1.964 |
| FP 500 µg BID | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, W8, n=64, 78, 86, 89, 79, 93 | 275.48 10^9 cells per liter (GI/L) | Standard Deviation 65.011 |
| FP 500 µg BID | Platelet Count and White Blood Cell Count at Baseline and Week 8 | Platelet count, BL, n=95, 98, 96, 99, 94, 104 | 269.80 10^9 cells per liter (GI/L) | Standard Deviation 65.376 |
| FP 500 µg BID | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, W8, n=64, 78, 86, 88, 80, 93 | 8.21 10^9 cells per liter (GI/L) | Standard Deviation 1.973 |
| FP 500 µg BID | Platelet Count and White Blood Cell Count at Baseline and Week 8 | WBC count, BL, n=95, 98, 96, 99, 94, 104 | 8.25 10^9 cells per liter (GI/L) | Standard Deviation 2.4 |
Secondary
Red Blood Cell Count at Baseline and Week 8
Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).
Time frame: Baseline and Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.67 10^12 cells per liter (TI/L) | Standard Deviation 0.413 |
| Placebo | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.61 10^12 cells per liter (TI/L) | Standard Deviation 0.423 |
| GW685698X 200 µg OD | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.69 10^12 cells per liter (TI/L) | Standard Deviation 0.438 |
| GW685698X 200 µg OD | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.64 10^12 cells per liter (TI/L) | Standard Deviation 0.472 |
| GW685698X 400 µg OD | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.64 10^12 cells per liter (TI/L) | Standard Deviation 0.413 |
| GW685698X 400 µg OD | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.57 10^12 cells per liter (TI/L) | Standard Deviation 0.383 |
| GW685698X 600 µg OD | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.52 10^12 cells per liter (TI/L) | Standard Deviation 0.442 |
| GW685698X 600 µg OD | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.60 10^12 cells per liter (TI/L) | Standard Deviation 0.428 |
| GW685698X 800 µg OD | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.66 10^12 cells per liter (TI/L) | Standard Deviation 0.416 |
| GW685698X 800 µg OD | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.65 10^12 cells per liter (TI/L) | Standard Deviation 0.425 |
| FP 500 µg BID | Red Blood Cell Count at Baseline and Week 8 | Baseline, n=95, 98, 96, 100, 94, 104 | 4.64 10^12 cells per liter (TI/L) | Standard Deviation 0.421 |
| FP 500 µg BID | Red Blood Cell Count at Baseline and Week 8 | Week 8, n=64, 78, 86, 89, 80, 93 | 4.61 10^12 cells per liter (TI/L) | Standard Deviation 0.43 |
Secondary
Urine pH at Baseline and Week 8/Early Withdrawal
Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Baseline and Week 8/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 6.11 scores on a scale | Standard Deviation 0.534 |
| Placebo | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 5.71 scores on a scale | Standard Deviation 0.267 |
| Placebo | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 6.01 scores on a scale | Standard Deviation 0.405 |
| GW685698X 200 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 6.00 scores on a scale | Standard Deviation 0.416 |
| GW685698X 200 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 5.93 scores on a scale | Standard Deviation 0.429 |
| GW685698X 200 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | NA scores on a scale | — |
| GW685698X 400 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 5.91 scores on a scale | Standard Deviation 0.469 |
| GW685698X 400 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 6.01 scores on a scale | Standard Deviation 0.441 |
| GW685698X 400 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 6.00 scores on a scale | — |
| GW685698X 600 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 5.88 scores on a scale | Standard Deviation 0.479 |
| GW685698X 600 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 5.97 scores on a scale | Standard Deviation 0.494 |
| GW685698X 600 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 6.00 scores on a scale | Standard Deviation 0.482 |
| GW685698X 800 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 5.60 scores on a scale | Standard Deviation 0.418 |
| GW685698X 800 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 5.98 scores on a scale | Standard Deviation 0.493 |
| GW685698X 800 µg OD | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 5.92 scores on a scale | Standard Deviation 0.486 |
| FP 500 µg BID | Urine pH at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 5.88 scores on a scale | Standard Deviation 0.25 |
| FP 500 µg BID | Urine pH at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 6.04 scores on a scale | Standard Deviation 0.464 |
| FP 500 µg BID | Urine pH at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 5.88 scores on a scale | Standard Deviation 0.415 |
Secondary
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Time frame: Baseline and Week 8/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0221 ratio | Standard Deviation 0.00721 |
| Placebo | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0223 ratio | Standard Deviation 0.00633 |
| Placebo | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 1.0203 ratio | Standard Deviation 0.00685 |
| GW685698X 200 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0232 ratio | Standard Deviation 0.00762 |
| GW685698X 200 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | NA ratio | — |
| GW685698X 200 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0214 ratio | Standard Deviation 0.0069 |
| GW685698X 400 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0217 ratio | Standard Deviation 0.00786 |
| GW685698X 400 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 1.0380 ratio | — |
| GW685698X 400 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0223 ratio | Standard Deviation 0.0073 |
| GW685698X 600 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0230 ratio | Standard Deviation 0.0068 |
| GW685698X 600 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 1.0255 ratio | Standard Deviation 0.00311 |
| GW685698X 600 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0223 ratio | Standard Deviation 0.00653 |
| GW685698X 800 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0210 ratio | Standard Deviation 0.00692 |
| GW685698X 800 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 1.0200 ratio | Standard Deviation 0.00863 |
| GW685698X 800 µg OD | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0214 ratio | Standard Deviation 0.00702 |
| FP 500 µg BID | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Baseline, n=97, 98, 96, 102, 95, 103 | 1.0218 ratio | Standard Deviation 0.00774 |
| FP 500 µg BID | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | EW, n=7, 0, 1, 4, 5, 4 | 1.0233 ratio | Standard Deviation 0.00506 |
| FP 500 µg BID | Urine Specific Gravity at Baseline and Week 8/Early Withdrawal | Week 8, n=65, 79, 88, 90, 80, 92 | 1.0228 ratio | Standard Deviation 0.00813 |