Asthma
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444
Interventions
Combination inhaled corticosteroid and long-acting beta2-agonist
DRUGFluticasone propionate
Inhaled corticosteroid
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of asthma * Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol * FEV1 greater than or equal to fifty percent of predicted * Currently using moderate to high dose inhaled corticosteroid therapy
Exclusion criteria
* History of life threatening asthma * Respiratory infection or oral candidiasis * Asthma exacerbation * Uncontrolled disease or clinical abnormality * Allergies * Taking another investigational medication or prohibited medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | From the start of study medication until Visit 11 (Week 52)/Early Withdrawal | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Number of Participants With Severe Asthma Exacerbations During the Treatment Period | From the start of study medication until Visit 11 (Week 52)/Early Withdrawal | A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations. |
| Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Baseline; Week 12, Week 28, and Week 52/Early Withdrawal | A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants \>=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age. |
| Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline | Baseline and Week 12 | A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values. |
| Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline | Baseline and Week 28 | A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values. |
| Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline | Baseline and Week 52 | A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values. |
| Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | From Baseline until Visit 11/Early Withdrawal (52 weeks) | A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection. |
| Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | From Baseline until Visit 11/Early Withdrawal (52 weeks) | SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits. |
| Maximum Change From Baseline in Pulse Rate | From Baseline until Visit 11/Early Withdrawal (52 weeks) | Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits. |
| Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Baseline; Week 28, and Week 52 | P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of \>=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of \<0 mmHg, \>=0 to \<4 mmHg, \>=4 to \<7 mmHg, \>=7 to \<11 mmHg, and \>=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Baseline; Week 28 and Week 52 | Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal | The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline. |
| Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | 0-24 hours at Screening, Day 1, Week 28, and Week 52 | Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. |
| Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | 0-24 hours at Screening, Day 1, Week 28, and Week 52 | Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist. |
Countries
Germany, Thailand, Ukraine, United States
Participant flow
Recruitment details
Participants were randomized in a 2:2:1 ratio to Fluticasone Furoate/GW642444 Inhalation Powder (two strengths: 200/25 micrograms (µg) once daily and 100/25 µg once daily) and fluticasone propionate 500 µg twice daily, respectively.
Pre-assignment details
Participants meeting all inclusion criteria and none of the exclusion criteria during the screening visit entered a 2-week Run-in Period for completion of Baseline safety evaluations and to obtain Baseline measures of asthma status. At Visit 2, participants were randomized to a 52-week Double-blind Treatment Period.
Participants by arm
| Arm | Count |
|---|---|
| FF/VI 100/25 µg OD Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period. | 201 |
| FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period. | 202 |
| FP 500 µg BID Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period. | 100 |
| Total | 503 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 2-week Run-in Period | Did Not Meet Continuation Criteria | 97 | 0 | 0 | 0 |
| 2-week Run-in Period | Lost to Follow-up | 2 | 0 | 0 | 0 |
| 2-week Run-in Period | Physician Decision | 3 | 0 | 0 | 0 |
| 2-week Run-in Period | Protocol Violation | 1 | 0 | 0 | 0 |
| 2-week Run-in Period | Withdrawal by Subject | 11 | 0 | 0 | 0 |
| 52-week Double-blind Treatment Period | Adverse Event | 0 | 5 | 3 | 6 |
| 52-week Double-blind Treatment Period | Lack of Efficacy | 0 | 1 | 4 | 1 |
| 52-week Double-blind Treatment Period | Lost to Follow-up | 0 | 1 | 3 | 4 |
| 52-week Double-blind Treatment Period | Physician Decision | 0 | 1 | 0 | 3 |
| 52-week Double-blind Treatment Period | Protocol-defined Stopping Criteria | 0 | 14 | 16 | 4 |
| 52-week Double-blind Treatment Period | Protocol Violation | 0 | 8 | 8 | 2 |
| 52-week Double-blind Treatment Period | Withdrawal by Subject | 0 | 10 | 7 | 9 |
Baseline characteristics
| Characteristic | FF/VI 100/25 µg OD | FF/VI 200/25 µg OD | FP 500 µg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 39.7 Years STANDARD_DEVIATION 15.85 | 38.5 Years STANDARD_DEVIATION 15.64 | 38.6 Years STANDARD_DEVIATION 15.97 | 39.0 Years STANDARD_DEVIATION 15.77 |
| Race/Ethnicity, Customized African American/African Heritage | 15 participants | 17 participants | 6 participants | 38 participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian - Mixed Race | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 50 participants | 51 participants | 24 participants | 125 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 4 participants | 1 participants | 0 participants | 5 participants |
| Race/Ethnicity, Customized White - Mixed Race | 2 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 129 participants | 132 participants | 68 participants | 329 participants |
| Sex: Female, Male Female | 130 Participants | 124 Participants | 62 Participants | 316 Participants |
| Sex: Female, Male Male | 71 Participants | 78 Participants | 38 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 108 / 201 | 105 / 202 | 61 / 100 |
| serious Total, serious adverse events | 3 / 201 | 1 / 202 | 7 / 100 |
Outcome results
Primary
Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 12, n=172, 182, 87 | 0.1 Grams per liter (G/L) | Standard Deviation 2.69 |
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 28, n=180, 176, 79 | -0.2 Grams per liter (G/L) | Standard Deviation 2.68 |
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 52, n=157, 159, 67 | -0.1 Grams per liter (G/L) | Standard Deviation 2.81 |
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 12, n=172, 182, 87 | -0.6 Grams per liter (G/L) | Standard Deviation 4.13 |
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 28, n=180, 176, 79 | -1.1 Grams per liter (G/L) | Standard Deviation 3.9 |
| FF/VI 100/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 52, n=157, 159, 67 | -0.7 Grams per liter (G/L) | Standard Deviation 4.53 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 52, n=157, 159, 67 | -1.4 Grams per liter (G/L) | Standard Deviation 4.6 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 12, n=172, 182, 87 | 0.2 Grams per liter (G/L) | Standard Deviation 2.87 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 12, n=172, 182, 87 | -0.1 Grams per liter (G/L) | Standard Deviation 4.5 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 28, n=180, 176, 79 | -1.0 Grams per liter (G/L) | Standard Deviation 4.47 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 28, n=180, 176, 79 | -0.3 Grams per liter (G/L) | Standard Deviation 2.79 |
| FF/VI 200/25 µg OD | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 52, n=157, 159, 67 | -0.8 Grams per liter (G/L) | Standard Deviation 2.72 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 28, n=180, 176, 79 | -0.4 Grams per liter (G/L) | Standard Deviation 2.76 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 52, n=157, 159, 67 | -0.5 Grams per liter (G/L) | Standard Deviation 2.54 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 52, n=157, 159, 67 | -1.0 Grams per liter (G/L) | Standard Deviation 4.38 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 12, n=172, 182, 87 | -0.6 Grams per liter (G/L) | Standard Deviation 3.96 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Albumin, Week 12, n=172, 182, 87 | -0.5 Grams per liter (G/L) | Standard Deviation 2.64 |
| FP 500 µg BID | Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal | Total Protein, Week 28, n=180, 176, 79 | -0.5 Grams per liter (G/L) | Standard Deviation 4.33 |
Primary
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 52, n=157, 157, 67 | -4.0 International units per liter (IU/L) | Standard Deviation 30.67 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 52, n=157, 159, 67 | 2.7 International units per liter (IU/L) | Standard Deviation 40.34 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 12, n=171, 181, 87 | -0.9 International units per liter (IU/L) | Standard Deviation 8.07 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 28, n=180, 176, 79 | -1.0 International units per liter (IU/L) | Standard Deviation 32.68 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 28, n=180, 176, 79 | 3.3 International units per liter (IU/L) | Standard Deviation 33.79 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 28, n=179, 176, 79 | -1.4 International units per liter (IU/L) | Standard Deviation 8.42 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 12, n=158, 165, 84 | -3.0 International units per liter (IU/L) | Standard Deviation 18.76 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 12, n=172, 182, 87 | 0.9 International units per liter (IU/L) | Standard Deviation 12.9 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 52, n=156, 158, 67 | -1.8 International units per liter (IU/L) | Standard Deviation 8.78 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 12, n=172, 182, 87 | -1.0 International units per liter (IU/L) | Standard Deviation 10.43 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 28, n=180, 176, 79 | -1.6 International units per liter (IU/L) | Standard Deviation 10.08 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 28, n=180, 176, 79 | 2.0 International units per liter (IU/L) | Standard Deviation 68.72 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 52, n=157, 159, 67 | -0.7 International units per liter (IU/L) | Standard Deviation 69.12 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 12, n=172, 181, 87 | 10.8 International units per liter (IU/L) | Standard Deviation 92.06 |
| FF/VI 100/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 52, n=157, 159, 67 | -1.8 International units per liter (IU/L) | Standard Deviation 12.4 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 28, n=180, 176, 79 | -9.9 International units per liter (IU/L) | Standard Deviation 247.61 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 12, n=158, 165, 84 | -2.6 International units per liter (IU/L) | Standard Deviation 29.65 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 28, n=180, 176, 79 | -5.8 International units per liter (IU/L) | Standard Deviation 30.56 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 52, n=157, 157, 67 | -7.2 International units per liter (IU/L) | Standard Deviation 34.65 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 12, n=172, 182, 87 | -0.2 International units per liter (IU/L) | Standard Deviation 13.51 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 28, n=180, 176, 79 | -0.1 International units per liter (IU/L) | Standard Deviation 10.59 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 52, n=157, 159, 67 | -1.3 International units per liter (IU/L) | Standard Deviation 11.13 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 12, n=171, 181, 87 | -0.3 International units per liter (IU/L) | Standard Deviation 12.05 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 28, n=179, 176, 79 | -0.9 International units per liter (IU/L) | Standard Deviation 11.6 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 52, n=156, 158, 67 | -1.9 International units per liter (IU/L) | Standard Deviation 11.21 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 12, n=172, 182, 87 | -0.1 International units per liter (IU/L) | Standard Deviation 18.23 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 28, n=180, 176, 79 | -0.6 International units per liter (IU/L) | Standard Deviation 17.63 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 52, n=157, 159, 67 | -2.7 International units per liter (IU/L) | Standard Deviation 15.99 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 12, n=172, 181, 87 | -11.5 International units per liter (IU/L) | Standard Deviation 254.71 |
| FF/VI 200/25 µg OD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 52, n=157, 159, 67 | -16.8 International units per liter (IU/L) | Standard Deviation 266.48 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 28, n=180, 176, 79 | -5.7 International units per liter (IU/L) | Standard Deviation 24.33 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 28, n=180, 176, 79 | -0.2 International units per liter (IU/L) | Standard Deviation 11.85 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 52, n=157, 159, 67 | -0.1 International units per liter (IU/L) | Standard Deviation 9.78 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 12, n=158, 165, 84 | -4.7 International units per liter (IU/L) | Standard Deviation 24.47 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 52, n=157, 159, 67 | -0.5 International units per liter (IU/L) | Standard Deviation 13.3 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 28, n=180, 176, 79 | 0.4 International units per liter (IU/L) | Standard Deviation 11.96 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 52, n=157, 159, 67 | -27.7 International units per liter (IU/L) | Standard Deviation 274.14 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 12, n=172, 181, 87 | -18.3 International units per liter (IU/L) | Standard Deviation 223.59 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALT, Week 12, n=172, 182, 87 | -0.3 International units per liter (IU/L) | Standard Deviation 12.03 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | ALP, Week 52, n=157, 157, 67 | -9.3 International units per liter (IU/L) | Standard Deviation 27.54 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 52, n=156, 158, 67 | -0.2 International units per liter (IU/L) | Standard Deviation 9.22 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 28, n=179, 176, 79 | 1.3 International units per liter (IU/L) | Standard Deviation 10.65 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine Kinase, Week 28, n=180, 176, 79 | 15.3 International units per liter (IU/L) | Standard Deviation 441.68 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | GGT, Week 12, n=172, 182, 87 | -1.7 International units per liter (IU/L) | Standard Deviation 12.12 |
| FP 500 µg BID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal | AST, Week 12, n=171, 181, 87 | 0.3 International units per liter (IU/L) | Standard Deviation 8.69 |
Primary
Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 28, n=179, 176, 79 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.9 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 28, n=180, 176, 79 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 52, n=157, 159, 67 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 12, n=171, 181, 87 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.13 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 12, n=172, 182, 87 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.43 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 52, n=156, 158, 67 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.53 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 12, n=172, 181, 87 | 0.33 Millimoles per liter (mmol/L) | Standard Deviation 1.873 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 28, n=180, 175, 79 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 1.547 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 52, n=157, 159, 67 | 0.45 Millimoles per liter (mmol/L) | Standard Deviation 1.839 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 12, n=157, 165, 84 | -0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.572 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 28, n=179, 176, 79 | -0.12 Millimoles per liter (mmol/L) | Standard Deviation 0.467 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 52, n=156, 156, 67 | -0.18 Millimoles per liter (mmol/L) | Standard Deviation 0.461 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 12, n=172, 182, 87 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 28, n=180, 176, 79 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.46 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 52, n=157, 159, 67 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.57 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 12, n=172, 182, 87 | 0.24 Millimoles per liter (mmol/L) | Standard Deviation 1.299 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 28, n=180, 176, 79 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 1.46 |
| FF/VI 100/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 52, n=157, 159, 67 | 0.15 Millimoles per liter (mmol/L) | Standard Deviation 1.244 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 52, n=157, 159, 67 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 1.479 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 12, n=172, 182, 87 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 3.5 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 12, n=157, 165, 84 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 0.721 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 12, n=172, 182, 87 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.61 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 28, n=180, 176, 79 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 52, n=157, 159, 67 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 12, n=172, 182, 87 | 0.36 Millimoles per liter (mmol/L) | Standard Deviation 1.237 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 52, n=157, 159, 67 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.67 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 28, n=179, 176, 79 | -0.15 Millimoles per liter (mmol/L) | Standard Deviation 0.449 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 28, n=180, 176, 79 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.124 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 12, n=171, 181, 87 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.91 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 52, n=157, 159, 67 | 0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.426 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 28, n=180, 176, 79 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.65 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 28, n=179, 176, 79 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.61 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 28, n=180, 175, 79 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 1.556 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 52, n=156, 156, 67 | -0.12 Millimoles per liter (mmol/L) | Standard Deviation 0.535 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 52, n=156, 158, 67 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| FF/VI 200/25 µg OD | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 12, n=172, 181, 87 | 0.17 Millimoles per liter (mmol/L) | Standard Deviation 2.085 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 52, n=156, 158, 67 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 12, n=172, 181, 87 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 1.233 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 28, n=180, 175, 79 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.442 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 52, n=157, 159, 67 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Glucose, Week 52, n=157, 159, 67 | -0.20 Millimoles per liter (mmol/L) | Standard Deviation 1.191 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 52, n=157, 159, 67 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 1.9 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 12, n=157, 165, 84 | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.606 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 28, n=179, 176, 79 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.617 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 12, n=172, 182, 87 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.757 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Potassium, Week 52, n=156, 156, 67 | -0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.446 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 12, n=172, 182, 87 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.28 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 28, n=180, 176, 79 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 12, n=172, 182, 87 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Chloride, Week 52, n=157, 159, 67 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 12, n=171, 181, 87 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.72 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | CO2 content/bicarbonate, Week 28, n=179, 176, 79 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.6 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Sodium, Week 28, n=180, 176, 79 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.74 |
| FP 500 µg BID | Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal | Urea/BUN, Week 28, n=180, 176, 79 | 0.41 Millimoles per liter (mmol/L) | Standard Deviation 2.676 |
Primary
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 12, n=172, 182, 87 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 0.99 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 28, n=180, 176, 79 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 0.97 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 52, n=157, 159, 67 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 0.99 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 12, n=172, 182, 87 | -1.4 Micromoles per liter (µmol/L) | Standard Deviation 3.11 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 28, n=180, 175, 79 | -1.3 Micromoles per liter (µmol/L) | Standard Deviation 3.09 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 52, n=157, 159, 67 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 3.08 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 12, n=172, 182, 87 | -1.7 Micromoles per liter (µmol/L) | Standard Deviation 3.62 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 28, n=180, 175, 79 | -1.6 Micromoles per liter (µmol/L) | Standard Deviation 3.61 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 52, n=157, 159, 67 | -2.4 Micromoles per liter (µmol/L) | Standard Deviation 3.58 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 12, n=172, 181, 87 | 3.00 Micromoles per liter (µmol/L) | Standard Deviation 10.214 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 28, n=180, 176, 79 | 7.03 Micromoles per liter (µmol/L) | Standard Deviation 19.264 |
| FF/VI 100/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 52, n=157, 159, 67 | 2.74 Micromoles per liter (µmol/L) | Standard Deviation 9.45 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 52, n=157, 159, 67 | 3.14 Micromoles per liter (µmol/L) | Standard Deviation 11.31 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 12, n=172, 182, 87 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 0.98 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 12, n=172, 182, 87 | -1.1 Micromoles per liter (µmol/L) | Standard Deviation 3.46 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 52, n=157, 159, 67 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 2.93 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 28, n=180, 176, 79 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.01 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 52, n=157, 159, 67 | -1.6 Micromoles per liter (µmol/L) | Standard Deviation 2.51 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 28, n=180, 176, 79 | 5.10 Micromoles per liter (µmol/L) | Standard Deviation 10.316 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 52, n=157, 159, 67 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 1 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 28, n=180, 175, 79 | -1.2 Micromoles per liter (µmol/L) | Standard Deviation 3.55 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 28, n=180, 175, 79 | -0.9 Micromoles per liter (µmol/L) | Standard Deviation 2.87 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 12, n=172, 182, 87 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 2.86 |
| FF/VI 200/25 µg OD | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 12, n=172, 181, 87 | 3.18 Micromoles per liter (µmol/L) | Standard Deviation 7.983 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 12, n=172, 182, 87 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 3.04 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 28, n=180, 175, 79 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 3.14 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 12, n=172, 181, 87 | 3.99 Micromoles per liter (µmol/L) | Standard Deviation 8.056 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Indirect bilirubin, Week 52, n=157, 159, 67 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 2.68 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 12, n=172, 182, 87 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 3.44 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 28, n=180, 175, 79 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 3.46 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 28, n=180, 176, 79 | 17.43 Micromoles per liter (µmol/L) | Standard Deviation 92.175 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 12, n=172, 182, 87 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.93 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 28, n=180, 176, 79 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.94 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Total Bilirubin, Week 52, n=157, 159, 67 | -1.0 Micromoles per liter (µmol/L) | Standard Deviation 3.14 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Direct bilirubin, Week 52, n=157, 159, 67 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.9 |
| FP 500 µg BID | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal | Creatinine, Week 52, n=157, 159, 67 | 3.32 Micromoles per liter (µmol/L) | Standard Deviation 9.982 |
Primary
Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 28, n=169, 169, 77 | -0.039 10^9 cells per liter (GI/L) | Standard Deviation 0.331 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 12, n=171, 170, 86 | 0.392 10^9 cells per liter (GI/L) | Standard Deviation 1.6161 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 12, n=171, 170, 86 | -0.010 10^9 cells per liter (GI/L) | Standard Deviation 0.3226 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 52, n=155, 155, 71 | -0.023 10^9 cells per liter (GI/L) | Standard Deviation 0.3273 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 28, n=169, 169, 77 | 0.632 10^9 cells per liter (GI/L) | Standard Deviation 1.5922 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 52, n=136, 136, 60 | 0.524 10^9 cells per liter (GI/L) | Standard Deviation 1.4589 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 12, n=167, 159, 78 | -1.3 10^9 cells per liter (GI/L) | Standard Deviation 39.44 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 28, n=164, 165, 74 | 1.0 10^9 cells per liter (GI/L) | Standard Deviation 44.49 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 52, n=147, 151, 68 | 1.8 10^9 cells per liter (GI/L) | Standard Deviation 43.8 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 12, n=173, 170, 86 | 0.51 10^9 cells per liter (GI/L) | Standard Deviation 1.744 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 28, n=170, 169, 77 | 0.74 10^9 cells per liter (GI/L) | Standard Deviation 1.758 |
| FF/VI 100/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 52, n=156, 156, 71 | 0.91 10^9 cells per liter (GI/L) | Standard Deviation 1.639 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 52, n=156, 156, 71 | 0.83 10^9 cells per liter (GI/L) | Standard Deviation 2.046 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 28, n=169, 169, 77 | -0.083 10^9 cells per liter (GI/L) | Standard Deviation 0.3698 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 52, n=147, 151, 68 | 4.6 10^9 cells per liter (GI/L) | Standard Deviation 38.49 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 12, n=167, 159, 78 | 1.5 10^9 cells per liter (GI/L) | Standard Deviation 68.1 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 12, n=171, 170, 86 | -0.057 10^9 cells per liter (GI/L) | Standard Deviation 0.3841 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 52, n=136, 136, 60 | 0.612 10^9 cells per liter (GI/L) | Standard Deviation 1.91 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 28, n=170, 169, 77 | 0.74 10^9 cells per liter (GI/L) | Standard Deviation 2.103 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 28, n=164, 165, 74 | 3.5 10^9 cells per liter (GI/L) | Standard Deviation 35.06 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 52, n=155, 155, 71 | -0.037 10^9 cells per liter (GI/L) | Standard Deviation 0.3171 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 28, n=169, 169, 77 | 0.679 10^9 cells per liter (GI/L) | Standard Deviation 2.0157 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 12, n=171, 170, 86 | 0.469 10^9 cells per liter (GI/L) | Standard Deviation 1.6904 |
| FF/VI 200/25 µg OD | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 12, n=173, 170, 86 | 0.50 10^9 cells per liter (GI/L) | Standard Deviation 2.007 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 12, n=171, 170, 86 | 0.493 10^9 cells per liter (GI/L) | Standard Deviation 1.7488 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 28, n=169, 169, 77 | 0.750 10^9 cells per liter (GI/L) | Standard Deviation 2.013 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 12, n=173, 170, 86 | 0.39 10^9 cells per liter (GI/L) | Standard Deviation 1.906 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Total ANC, Week 52, n=136, 136, 60 | 0.748 10^9 cells per liter (GI/L) | Standard Deviation 1.7946 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 12, n=167, 159, 78 | 1.5 10^9 cells per liter (GI/L) | Standard Deviation 43.26 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 28, n=164, 165, 74 | 12.4 10^9 cells per liter (GI/L) | Standard Deviation 43.59 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 28, n=170, 169, 77 | 0.79 10^9 cells per liter (GI/L) | Standard Deviation 2.028 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Platelet Count, Week 52, n=147, 151, 68 | 16.4 10^9 cells per liter (GI/L) | Standard Deviation 50.99 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 12, n=171, 170, 86 | -0.073 10^9 cells per liter (GI/L) | Standard Deviation 0.222 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 28, n=169, 169, 77 | -0.083 10^9 cells per liter (GI/L) | Standard Deviation 0.2363 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | WBC Count, Week 52, n=156, 156, 71 | 1.01 10^9 cells per liter (GI/L) | Standard Deviation 1.909 |
| FP 500 µg BID | Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophil count, Week 52, n=155, 155, 71 | -0.044 10^9 cells per liter (GI/L) | Standard Deviation 0.2539 |
Primary
Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -0.0017 Proportion of 1.0 | Standard Deviation 0.02213 |
| FF/VI 100/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -0.0073 Proportion of 1.0 | Standard Deviation 0.02307 |
| FF/VI 100/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -0.0027 Proportion of 1.0 | Standard Deviation 0.02906 |
| FF/VI 200/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -0.0005 Proportion of 1.0 | Standard Deviation 0.02464 |
| FF/VI 200/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -0.0013 Proportion of 1.0 | Standard Deviation 0.02654 |
| FF/VI 200/25 µg OD | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -0.0021 Proportion of 1.0 | Standard Deviation 0.02467 |
| FP 500 µg BID | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -0.0025 Proportion of 1.0 | Standard Deviation 0.02318 |
| FP 500 µg BID | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -0.0045 Proportion of 1.0 | Standard Deviation 0.02495 |
| FP 500 µg BID | Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -0.0028 Proportion of 1.0 | Standard Deviation 0.02168 |
Primary
Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -2.6 Grams per liter (g/L) | Standard Deviation 10.26 |
| FF/VI 100/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -2.1 Grams per liter (g/L) | Standard Deviation 7.64 |
| FF/VI 100/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -3.4 Grams per liter (g/L) | Standard Deviation 7.48 |
| FF/VI 200/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -2.9 Grams per liter (g/L) | Standard Deviation 7.47 |
| FF/VI 200/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -2.2 Grams per liter (g/L) | Standard Deviation 8.11 |
| FF/VI 200/25 µg OD | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -1.8 Grams per liter (g/L) | Standard Deviation 8.25 |
| FP 500 µg BID | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 52, n=157, 159, 72 | -3.0 Grams per liter (g/L) | Standard Deviation 8.77 |
| FP 500 µg BID | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 28, n=172, 170, 77 | -2.4 Grams per liter (g/L) | Standard Deviation 7.72 |
| FP 500 µg BID | Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal | Week 12, n=176, 172, 86 | -2.0 Grams per liter (g/L) | Standard Deviation 7.67 |
Primary
Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52
Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 28, n=179, 177, 80 | 0.5 ratio | Standard Deviation 4.79 |
| FF/VI 100/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 28, n=179, 177, 80 | 0.2 ratio | Standard Deviation 4.17 |
| FF/VI 100/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 52, n=167, 166, 72 | 0.4 ratio | Standard Deviation 5.86 |
| FF/VI 100/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 52, n=167, 166, 72 | 0.1 ratio | Standard Deviation 4.63 |
| FF/VI 200/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 52, n=167, 166, 72 | 0.2 ratio | Standard Deviation 5.57 |
| FF/VI 200/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 28, n=179, 177, 80 | -0.2 ratio | Standard Deviation 5.11 |
| FF/VI 200/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 52, n=167, 166, 72 | 0.2 ratio | Standard Deviation 4.89 |
| FF/VI 200/25 µg OD | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 28, n=179, 177, 80 | -0.2 ratio | Standard Deviation 6.49 |
| FP 500 µg BID | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 52, n=167, 166, 72 | 0.0 ratio | Standard Deviation 5.26 |
| FP 500 µg BID | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Right eye, Week 28, n=179, 177, 80 | 0.5 ratio | Standard Deviation 5.1 |
| FP 500 µg BID | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 52, n=167, 166, 72 | 0.3 ratio | Standard Deviation 4.77 |
| FP 500 µg BID | Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 | Left eye, Week 28, n=179, 177, 80 | 0.5 ratio | Standard Deviation 4.87 |
Primary
Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52
NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | 0.01 Scores on a scale | Standard Deviation 0.282 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | 0.01 Scores on a scale | Standard Deviation 0.292 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | 0.02 Scores on a scale | Standard Deviation 0.281 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.02 Scores on a scale | Standard Deviation 0.304 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.00 Scores on a scale | Standard Deviation 0.339 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | 0.00 Scores on a scale | Standard Deviation 0.284 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | -0.2 Scores on a scale | Standard Deviation 0.357 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | 0.1 Scores on a scale | Standard Deviation 0.292 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.01 Scores on a scale | Standard Deviation 0.336 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | -0.02 Scores on a scale | Standard Deviation 0.294 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | 0.00 Scores on a scale | Standard Deviation 0.34 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | -0.02 Scores on a scale | Standard Deviation 0.299 |
Primary
Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52
NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | 0.01 Scores on a scale | Standard Deviation 0.33 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | 0.02 Scores on a scale | Standard Deviation 0.236 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.00 Scores on a scale | Standard Deviation 0.351 |
| FF/VI 100/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | 0.01 Scores on a scale | Standard Deviation 0.256 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | 0.03 Scores on a scale | Standard Deviation 0.303 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | 0.03 Scores on a scale | Standard Deviation 0.303 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | 0.03 Scores on a scale | Standard Deviation 0.316 |
| FF/VI 200/25 µg OD | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.04 Scores on a scale | Standard Deviation 0.282 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Right eye, n=179, 177, 80 | -0.03 Scores on a scale | Standard Deviation 0.272 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 28, Left eye, n=179, 177, 80 | -0.02 Scores on a scale | Standard Deviation 0.27 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Right eye, n=167, 166, 72 | 0.02 Scores on a scale | Standard Deviation 0.371 |
| FP 500 µg BID | Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 | Week 52, Left eye, n=167, 166, 72 | 0.01 Scores on a scale | Standard Deviation 0.369 |
Primary
Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52
Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Left eye, n=167, 165, 72 | -0.011 Scores on a scale | Standard Deviation 0.0747 |
| FF/VI 100/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Left eye, n=179, 176, 80 | -0.008 Scores on a scale | Standard Deviation 0.0723 |
| FF/VI 100/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Right eye, n=167, 165, 72 | -0.008 Scores on a scale | Standard Deviation 0.0928 |
| FF/VI 100/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Right eye, n=179, 176, 80 | -0.003 Scores on a scale | Standard Deviation 0.0739 |
| FF/VI 200/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Right eye, n=179, 176, 80 | -0.001 Scores on a scale | Standard Deviation 0.0699 |
| FF/VI 200/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Left eye, n=167, 165, 72 | -0.012 Scores on a scale | Standard Deviation 0.0739 |
| FF/VI 200/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Right eye, n=167, 165, 72 | 0.003 Scores on a scale | Standard Deviation 0.0755 |
| FF/VI 200/25 µg OD | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Left eye, n=179, 176, 80 | -0.010 Scores on a scale | Standard Deviation 0.0706 |
| FP 500 µg BID | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Left eye, n=167, 165, 72 | -0.007 Scores on a scale | Standard Deviation 0.0638 |
| FP 500 µg BID | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 52, Right eye, n=167, 165, 72 | -0.012 Scores on a scale | Standard Deviation 0.0776 |
| FP 500 µg BID | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Right eye, n=179, 176, 80 | -0.008 Scores on a scale | Standard Deviation 0.0584 |
| FP 500 µg BID | Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 | Week 28, Left eye, n=179, 176, 80 | -0.004 Scores on a scale | Standard Deviation 0.0685 |
Primary
Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal
Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 28, n=169, 169, 77 | -1.11 Percentage | Standard Deviation 8.816 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 52, n=155, 155, 71 | 1.34 Percentage | Standard Deviation 9.389 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 52, n=155, 155, 71 | 0.02 Percentage | Standard Deviation 0.314 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 28, n=169, 169, 77 | 2.71 Percentage | Standard Deviation 10.221 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 12, n=171, 170, 86 | -0.35 Percentage | Standard Deviation 4.048 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 12, n=171, 170, 86 | 1.54 Percentage | Standard Deviation 10.883 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 28, n=169, 169, 77 | -0.66 Percentage | Standard Deviation 2.594 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 28, n=169, 169, 77 | -0.01 Percentage | Standard Deviation 0.319 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 52, n=155, 155, 71 | -0.19 Percentage | Standard Deviation 2.439 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 12, n=171, 170, 86 | -0.01 Percentage | Standard Deviation 0.33 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 28, n=169, 169, 77 | -0.97 Percentage | Standard Deviation 3.991 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 12, n=171, 170, 86 | -0.60 Percentage | Standard Deviation 2.692 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 52, n=155, 155, 71 | -0.33 Percentage | Standard Deviation 10.687 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 52, n=155, 155, 71 | -0.84 Percentage | Standard Deviation 4.096 |
| FF/VI 100/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 12, n=171, 170, 86 | -0.57 Percentage | Standard Deviation 9.28 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 52, n=155, 155, 71 | -0.03 Percentage | Standard Deviation 0.279 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 12, n=171, 170, 86 | -0.06 Percentage | Standard Deviation 0.331 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 28, n=169, 169, 77 | 0.00 Percentage | Standard Deviation 0.338 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 12, n=171, 170, 86 | -0.88 Percentage | Standard Deviation 3.825 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 28, n=169, 169, 77 | -1.34 Percentage | Standard Deviation 3.774 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 12, n=171, 170, 86 | -0.91 Percentage | Standard Deviation 8.414 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 52, n=155, 155, 71 | -0.03 Percentage | Standard Deviation 10.137 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 12, n=171, 170, 86 | -0.47 Percentage | Standard Deviation 2.5 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 28, n=169, 169, 77 | -0.53 Percentage | Standard Deviation 2.706 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 52, n=155, 155, 71 | 0.31 Percentage | Standard Deviation 2.598 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 12, n=171, 170, 86 | 2.32 Percentage | Standard Deviation 9.635 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 28, n=169, 169, 77 | 3.18 Percentage | Standard Deviation 12.008 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 52, n=155, 155, 71 | -0.90 Percentage | Standard Deviation 3.946 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 28, n=169, 169, 77 | -1.31 Percentage | Standard Deviation 10.2 |
| FF/VI 200/25 µg OD | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 52, n=155, 155, 71 | 0.66 Percentage | Standard Deviation 11.768 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 52, n=155, 155, 71 | -0.97 Percentage | Standard Deviation 8.532 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 28, n=169, 169, 77 | -1.66 Percentage | Standard Deviation 11.054 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 28, n=169, 169, 77 | 4.19 Percentage | Standard Deviation 13.745 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 28, n=169, 169, 77 | -1.63 Percentage | Standard Deviation 3.574 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 12, n=171, 170, 86 | -1.23 Percentage | Standard Deviation 3.391 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 52, n=155, 155, 71 | -0.07 Percentage | Standard Deviation 0.319 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 12, n=171, 170, 86 | -0.08 Percentage | Standard Deviation 0.32 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Eosinophils, Week 52, n=155, 155, 71 | -1.19 Percentage | Standard Deviation 3.611 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Lymphocytes, Week 12, n=171, 170, 86 | -1.72 Percentage | Standard Deviation 8.449 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 28, n=169, 169, 77 | -0.84 Percentage | Standard Deviation 3.063 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Basophils, Week 28, n=169, 169, 77 | -0.06 Percentage | Standard Deviation 0.31 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 52, n=155, 155, 71 | -0.30 Percentage | Standard Deviation 2.337 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Monocytes, Week 12, n=171, 170, 86 | -0.86 Percentage | Standard Deviation 3.147 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 52, n=155, 155, 71 | 2.54 Percentage | Standard Deviation 10.112 |
| FP 500 µg BID | Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal | Segmented neutrophils, Week 12, n=171, 170, 86 | 3.89 Percentage | Standard Deviation 11.397 |
Primary
Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data
Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist.
Time frame: 0-24 hours at Screening, Day 1, Week 28, and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 132.6 beats per minute | Standard Deviation 17.18 |
| FF/VI 100/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 131.2 beats per minute | Standard Deviation 18.28 |
| FF/VI 100/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 127.5 beats per minute | Standard Deviation 17.93 |
| FF/VI 100/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 126.9 beats per minute | Standard Deviation 18.16 |
| FF/VI 200/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 128.1 beats per minute | Standard Deviation 16.63 |
| FF/VI 200/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 132.1 beats per minute | Standard Deviation 17.85 |
| FF/VI 200/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 127.4 beats per minute | Standard Deviation 16.62 |
| FF/VI 200/25 µg OD | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 130.8 beats per minute | Standard Deviation 19.5 |
| FP 500 µg BID | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 122.8 beats per minute | Standard Deviation 13.89 |
| FP 500 µg BID | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 129.2 beats per minute | Standard Deviation 18.77 |
| FP 500 µg BID | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 123.5 beats per minute | Standard Deviation 14.93 |
| FP 500 µg BID | Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 133.0 beats per minute | Standard Deviation 16.17 |
Primary
Maximum Change From Baseline in Pulse Rate
Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.
Time frame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FF/VI 100/25 µg OD | Maximum Change From Baseline in Pulse Rate | 10.5 Beats per minute | Standard Deviation 9.3 |
| FF/VI 200/25 µg OD | Maximum Change From Baseline in Pulse Rate | 10.0 Beats per minute | Standard Deviation 10.05 |
| FP 500 µg BID | Maximum Change From Baseline in Pulse Rate | 7.5 Beats per minute | Standard Deviation 8.29 |
Primary
Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)
SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.
Time frame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Maximum post-Baseline change in SBP | 10.2 Millimeters of mercury (mmHg) | Standard Deviation 11.05 |
| FF/VI 100/25 µg OD | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Minimum post-Baseline change in DBP | -8.9 Millimeters of mercury (mmHg) | Standard Deviation 7.7 |
| FF/VI 200/25 µg OD | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Maximum post-Baseline change in SBP | 10.0 Millimeters of mercury (mmHg) | Standard Deviation 10.17 |
| FF/VI 200/25 µg OD | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Minimum post-Baseline change in DBP | -9.0 Millimeters of mercury (mmHg) | Standard Deviation 8.44 |
| FP 500 µg BID | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Maximum post-Baseline change in SBP | 11.3 Millimeters of mercury (mmHg) | Standard Deviation 11.09 |
| FP 500 µg BID | Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) | Minimum post-Baseline change in DBP | -8.0 Millimeters of mercury (mmHg) | Standard Deviation 7.76 |
Primary
Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)
The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline.
Time frame: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcB | 19.0 Milliseconds (msec) | Standard Deviation 17.33 |
| FF/VI 100/25 µg OD | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcF | 12.8 Milliseconds (msec) | Standard Deviation 14.51 |
| FF/VI 200/25 µg OD | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcB | 16.4 Milliseconds (msec) | Standard Deviation 19.49 |
| FF/VI 200/25 µg OD | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcF | 11.6 Milliseconds (msec) | Standard Deviation 15.6 |
| FP 500 µg BID | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcB | 13.2 Milliseconds (msec) | Standard Deviation 16.57 |
| FP 500 µg BID | Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) | QTcF | 11.4 Milliseconds (msec) | Standard Deviation 12.81 |
Primary
Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data
Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist.
Time frame: 0-24 hours at Screening, Day 1, Week 28, and Week 52
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 |
|---|---|---|---|---|
| FF/VI 100/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 79.0 beats per minute | Standard Deviation 8.23 |
| FF/VI 100/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 78.8 beats per minute | Standard Deviation 8.72 |
| FF/VI 100/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 77.8 beats per minute | Standard Deviation 8.9 |
| FF/VI 100/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 78.6 beats per minute | Standard Deviation 7.89 |
| FF/VI 200/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 78.0 beats per minute | Standard Deviation 10.15 |
| FF/VI 200/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 79.1 beats per minute | Standard Deviation 9.55 |
| FF/VI 200/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 78.7 beats per minute | Standard Deviation 9.45 |
| FF/VI 200/25 µg OD | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 77.5 beats per minute | Standard Deviation 9.01 |
| FP 500 µg BID | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Screening, n=111, 116, 49 | 79.8 beats per minute | Standard Deviation 8.75 |
| FP 500 µg BID | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 28, n=95, 90, 39 | 74.9 beats per minute | Standard Deviation 8.54 |
| FP 500 µg BID | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Day 1, n=104, 113, 47 | 77.4 beats per minute | Standard Deviation 7.66 |
| FP 500 µg BID | Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data | Week 52, n=88, 82, 37 | 74.8 beats per minute | Standard Deviation 8.62 |
Primary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any AE | 139 participants |
| FF/VI 100/25 µg OD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 3 participants |
| FF/VI 200/25 µg OD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any AE | 134 participants |
| FF/VI 200/25 µg OD | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 1 participants |
| FP 500 µg BID | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any AE | 73 participants |
| FP 500 µg BID | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 7 participants |
Primary
Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline
A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection.
Time frame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Evidence of oral candidiasis | 15 participants |
| FF/VI 100/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Positive culture swab | 13 participants |
| FF/VI 100/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Negative culture swab | 1 participants |
| FF/VI 100/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | No swab result available | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | No swab result available | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Evidence of oral candidiasis | 14 participants |
| FF/VI 200/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Negative culture swab | 2 participants |
| FF/VI 200/25 µg OD | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Positive culture swab | 11 participants |
| FP 500 µg BID | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | No swab result available | 0 participants |
| FP 500 µg BID | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Positive culture swab | 3 participants |
| FP 500 µg BID | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Negative culture swab | 2 participants |
| FP 500 µg BID | Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline | Evidence of oral candidiasis | 5 participants |
Primary
Number of Participants With Severe Asthma Exacerbations During the Treatment Period
A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.
Time frame: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With Severe Asthma Exacerbations During the Treatment Period | 3 participants |
| FF/VI 200/25 µg OD | Number of Participants With Severe Asthma Exacerbations During the Treatment Period | 6 participants |
| FP 500 µg BID | Number of Participants With Severe Asthma Exacerbations During the Treatment Period | 3 participants |
Primary
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52
Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of \<0 mmHg, \>=0 to \<4 mmHg, \>=4 to \<7 mmHg, \>=7 to \<11 mmHg, and \>=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 101 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg, Week 52, n=167,166, 72 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 11 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 101 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 88 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg,Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 94 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 52, n=167, 166, 72 | 66 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 7 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 52, n=167, 166, 72 | 63 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 10 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 28, n=179, 177, 80 | 71 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 52, n=167, 166, 72 | 2 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 28, n=179, 177, 80 | 73 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 28, n=179, 177, 80 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 6 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 28, n=179, 177, 80 | 78 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 92 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 12 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 28, n=179, 177, 80 | 61 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 110 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg,Week 28, n=179, 177, 80 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 52, n=167, 166, 72 | 69 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 83 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 14 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 52, n=167, 166, 72 | 61 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 93 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg, Week 52, n=167,166, 72 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg, Week 52, n=167,166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=7 to <11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=11 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 52, n=167, 166, 72 | 32 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 46 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, <0 mmHg, Week 28, n=179, 177, 80 | 38 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=11 mmHg, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=7 to <11 mmHg,Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 28, n=179, 177, 80 | 32 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, <0 mmHg, Week 52, n=167, 166, 72 | 33 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=4 to <7 mmHg, Week 28, n=179, 177, 80 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 40 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Left eye, >=0 to <4 mmHg, Week 52, n=167, 166, 72 | 36 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 | Right eye, >=0 to <4 mmHg, Week 28, n=179, 177, 80 | 38 participants |
Primary
Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52
C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28 and Week 52
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 (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 6 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 169 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 151 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 6 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 6 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 154 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 11 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 7 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 167 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 4 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 6 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 158 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 2 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 6 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 6 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 166 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 172 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 4 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 156 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 69 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 75 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 75 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 66 participants |
Primary
Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52
P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of \>=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Week 28, and Week 52
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 (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 174 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 175 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 4 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 1 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 163 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 2 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 2 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 163 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 3 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 2 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 164 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 164 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 175 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 2 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 1 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 175 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 1 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 28, n=179, 177, 80 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 52, n=167, 166, 72 | 72 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, <0.3, Week 28, n=179, 177, 80 | 79 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.3 and <0.5, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 28, n=179, 177, 80 | 80 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, <0.3, Week 52, n=167, 166, 72 | 72 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Left eye, >=0.5, Week 52, n=167, 166, 72 | 0 participants |
| FP 500 µg BID | Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 | Right eye, >=0.5, Week 52, n=167, 166, 72 | 0 participants |
Primary
Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion
A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants \>=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age.
Time frame: Baseline; Week 12, Week 28, and Week 52/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 (NUMBER) |
|---|---|---|---|
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To normal or no change , n=134, 140, 65 | 119 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To low, n=134, 140, 65 | 5 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To normal or no change, n=135, 131, 59 | 123 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To low, n=156, 156, 83 | 12 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To normal or no change, n=156, 156, 83 | 119 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To low, n=139, 140, 78 | 2 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To low, n=135, 131, 59 | 4 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To high, n=135, 131, 59 | 8 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To normal or no change, n=139, 140, 78 | 131 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To high, n=134, 140, 65 | 10 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To high, n=156, 156, 83 | 25 participants |
| FF/VI 100/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To high, n=139, 140, 78 | 6 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To low, n=156, 156, 83 | 9 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To high, n=135, 131, 59 | 8 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To low, n=135, 131, 59 | 3 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To high, n=134, 140, 65 | 7 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To low, n=134, 140, 65 | 2 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To high, n=139, 140, 78 | 7 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To normal or no change, n=139, 140, 78 | 128 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To low, n=139, 140, 78 | 5 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To normal or no change, n=135, 131, 59 | 120 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To normal or no change , n=134, 140, 65 | 131 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To high, n=156, 156, 83 | 21 participants |
| FF/VI 200/25 µg OD | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To normal or no change, n=156, 156, 83 | 126 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To normal or no change , n=134, 140, 65 | 57 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To normal or no change, n=139, 140, 78 | 67 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To normal or no change, n=135, 131, 59 | 47 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To high, n=135, 131, 59 | 3 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To low, n=139, 140, 78 | 9 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To normal or no change, n=156, 156, 83 | 58 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To low, n=134, 140, 65 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To low, n=156, 156, 83 | 17 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 52: To high, n=134, 140, 65 | 4 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | AVBP: To high, n=156, 156, 83 | 8 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 12: To high, n=139, 140, 78 | 2 participants |
| FP 500 µg BID | Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion | Week 28: To low, n=135, 131, 59 | 9 participants |
95% CI: [1.34, 2.08]
95% CI: [1.29, 2.13]
95% CI: [0.83, 1.33]
95% CI: [1.22, 1.89]
95% CI: [1.11, 1.84]
95% CI: [0.87, 1.38]
Primary
Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline
A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.
Time frame: Baseline and Week 12
Population: Urinary cortisol (UC) Population: participants in the ITT Population whose urine samples did not have confounding factors that affected the interpretation of results. These participants were determined prior to breaking the blind. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FF/VI 100/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline | 1.03 Ratio of LSGM of UCE to Baseline |
| FF/VI 200/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline | 0.93 Ratio of LSGM of UCE to Baseline |
| FP 500 µg BID | Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline | 0.61 Ratio of LSGM of UCE to Baseline |
p-value: <0.00195% CI: [1.34, 2.08]ANCOVA
p-value: <0.00195% CI: [1.22, 1.89]ANCOVA
Primary
Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline
A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.
Time frame: Baseline and Week 28
Population: UC Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FF/VI 100/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline | 1.05 Ratio of LSGM of UCE to Baseline |
| FF/VI 200/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline | 0.91 Ratio of LSGM of UCE to Baseline |
| FP 500 µg BID | Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline | 0.64 Ratio of LSGM of UCE to Baseline |
p-value: <0.00195% CI: [1.29, 2.13]ANCOVA
p-value: 0.00695% CI: [1.11, 1.84]ANCOVA
Primary
Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline
A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.
Time frame: Baseline and Week 52
Population: UC Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FF/VI 100/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline | 1.00 Ratio of LSGM of UCE to Baseline |
| FF/VI 200/25 µg OD | Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline | 1.04 Ratio of LSGM of UCE to Baseline |
| FP 500 µg BID | Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline | 0.95 Ratio of LSGM of UCE to Baseline |
p-value: 0.67495% CI: [0.83, 1.33]ANCOVA
p-value: 0.44495% CI: [0.87, 1.38]ANCOVA