Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

The frequency and severity of treatment-emergent adverse events (TEAEs); including clinically significant abnormal vital signs; ECGs; respiratory monitoring (including O2 saturation and spirometry); laboratory test results (including viral reactivation); cardiac telemetry results; and physical examination (PE) findings.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.ECG: ECGs will be recorded at Screening; Baseline; pre-morning dose and at 1; 2; and 4 hours post-morning dose on Day 1; 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14. O2 Saturation: O2 saturation to be taken at Baseline; predose to dosing and at 2 hours (±30 minutes) post-morning dose on each day of dosing; prior to discharge on Day 8; and on Day 14.Spirometry: Baseline; Day 8 and Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.Viral reactivation (EBV; HSV; VZV; CMV and HBV): Blood samples will be collected at Screening; prior to discharge on Day 8; and on Day 14.Cardiac telemetry monitoring: Continuous cardiac telemetry will be conducted for 48 hours; from the morning of Baseline (at least 24 hours prior to the first dose) to the morning of Day 2 (24 hours [+30 minutes] post first dose).Physical Examination: Complete PE during Screening and Symptom-directed PE at Baseline; Day 2; Day 5; Day 7; Day 8 and Day 14.];The frequency and severity of adverse events of special interest (AESIs); including clinically significant changes from baseline in coagulation parameters or platelets or persistent/recurrent symptomatic orthostatic hypotension.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.]

The frequency and severity of treatment-emergent adverse events (TEAEs); including clinically significant abnormal vital signs; ECGs; respiratory monitoring (including O2 saturation and spirometry); laboratory test results (including viral reactivation); cardiac telemetry results; and physical examination (PE) findings.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.ECG: ECGs will be recorded at Screening; Baseline; pre-morning dose and at 1; 2; and 4 hours post-morning dose on Day 1; 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14. O2 Saturation: O2 saturation to be taken at Baseline; predose to dosing and at 2 hours (±30 minutes) post-morning dose on each day of dosing; prior to discharge on Day 8; and on Day 14.Spirometry: Baseline; Day 8 and Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.Viral reactivation (EBV; HSV; VZV; CMV and HBV): Blood samples will be collected at Screening; prior to discharge on Day 8; and on Day 14.Cardiac telemetry monitoring: Continuous cardiac telemetry will be conducted for 48 hours; from the morning of Baseline (at least 24 hours prior to the first dose) to the morning of Day 2 (24 hours [+30 minutes] post first dose).Physical Examination: Complete PE during Screening and Symptom-directed PE at Baseline; Day 2; Day 5; Day 7; Day 8 and Day 14.];The frequency and severity of adverse events of special interest (AESIs); including clinically significant changes from baseline in coagulation parameters or platelets or persistent/recurrent symptomatic orthostatic hypotension.[AE: Screening; Baseline; Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8 and Day 14.Vital signs: Vitals and orthostatic BP will be obtained at Screening; Baseline; predose and 1; 2; 3; 4; 6; and 8 hours post-morning dose on Day 1; predose and 2 hours post-morning dose on Days 2 to 7; prior to discharge on Day 8; and on Day 14.Biochemistry; coagulation; hematology: Blood samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14. Urinalysis (including microscopic examination and examination for casts): Urine samples will be taken at Screening; Baseline; pre-morning dose on Days 2; 4; and 6; prior to discharge on Day 8; and on Day 14.]