Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double Blind, Placebo-controlled, Double Dummy, 4-way Cross-over, Dose Ascending Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK573719 (250, 500 and 1000 μg) and Tiotropium Bromide (18 μg) Via DPI in COPD Patients.
Brief Summary: GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 (Day 85)
C: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) (From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)); Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46))
D: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)

Answer: C