Trial Outcomes & Findings for Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin (NCT NCT01133522)

NCT ID: NCT01133522

Last Updated: 2018-11-02

Results Overview

The relationship of each adverse event to the investigational product was assessed by the investigator. A serious adverse event (SAE) is defined as an adverse event that * is fatal * is life threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: From the first dose of study drug until Day 85
• Results posted on: 2018-11-02

Participant Flow

This study enrolled hypercholesterolemic adults receiving stable statin therapy (7 cohorts: 5 on low-to-moderate-dose statins, 1 on high-dose statin therapy, and 1 with heterozygous familial hypercholesterolemia (HeFH) (score ≥9, World Health Organization criteria). First patient enrolled 28 June 2010. Last patient enrolled 24 June 2011.

Participants receiving low-to-moderate-dose statins were randomized 1:3 to placebo or evolocumab and sequentially assigned to 1 of 5 dose-escalation cohorts. The high-dose statin and HeFH cohorts were randomized 1:3 and 1:2 respectively to placebo or evolocumab. Placebo participants were pooled for the 5 dose-escalation cohorts.

Participant milestones

Measure	Placebo Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.	Evolocumab 35 mg QW × 6 Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.	Evolocumab 280 mg Q2W × 3 Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.	High Dose Statin - Placebo Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Overall Study STARTED	10	7	6	7	7	6	2	9	2	4
Overall Study Received Treatment	10	6	6	6	6	6	2	9	2	4
Overall Study COMPLETED	10	6	6	6	6	6	2	9	2	4
Overall Study NOT COMPLETED	0	1	0	1	1	0	0	0	0	0

Reasons for withdrawal

Measure	Placebo Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.	Evolocumab 35 mg QW × 6 Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.	Evolocumab 280 mg Q2W × 3 Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.	High Dose Statin - Placebo Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Overall Study Withdrawal by Subject	0	1	0	1	0	0	0	0	0	0
Overall Study Physician Decision	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 Participants Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 Participants Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 Participants Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 Participants Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Total n=57 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 7.5 • n=5 Participants	61.3 years STANDARD_DEVIATION 4.0 • n=7 Participants	63.7 years STANDARD_DEVIATION 6.3 • n=5 Participants	56.2 years STANDARD_DEVIATION 7.3 • n=4 Participants	56.3 years STANDARD_DEVIATION 8.6 • n=21 Participants	53.8 years STANDARD_DEVIATION 4.9 • n=8 Participants	62.0 years STANDARD_DEVIATION 1.4 • n=8 Participants	58.2 years STANDARD_DEVIATION 7.6 • n=24 Participants	54.5 years STANDARD_DEVIATION 10.6 • n=42 Participants	45.0 years STANDARD_DEVIATION 15.1 • n=42 Participants	56.9 years STANDARD_DEVIATION 8.4 • n=42 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	26 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	31 Participants n=42 Participants
Race/Ethnicity, Customized White or Caucasian	9 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	3 participants n=8 Participants	2 participants n=8 Participants	7 participants n=24 Participants	2 participants n=42 Participants	2 participants n=42 Participants	47 participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	2 participants n=42 Participants	2 participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	3 participants n=8 Participants	0 participants n=8 Participants	2 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	7 participants n=42 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	1 participants n=42 Participants
Race/Ethnicity, Customized Japanese	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized Aborigine	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Low-Density Lipoprotein Cholesterol (LDL-C) Concentration	108.9 mg/dL STANDARD_DEVIATION 21.9 • n=5 Participants	126.7 mg/dL STANDARD_DEVIATION 22.1 • n=7 Participants	106.5 mg/dL STANDARD_DEVIATION 29.4 • n=5 Participants	113.7 mg/dL STANDARD_DEVIATION 14.5 • n=4 Participants	105.8 mg/dL STANDARD_DEVIATION 17.0 • n=21 Participants	120.3 mg/dL STANDARD_DEVIATION 33.0 • n=8 Participants	99.0 mg/dL STANDARD_DEVIATION 31.1 • n=8 Participants	100.2 mg/dL STANDARD_DEVIATION 25.5 • n=24 Participants	168.5 mg/dL STANDARD_DEVIATION 57.3 • n=42 Participants	134.5 mg/dL STANDARD_DEVIATION 31.1 • n=42 Participants	114.1 mg/dL STANDARD_DEVIATION 27.8 • n=42 Participants
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Concentration	429.0 ng/mL STANDARD_DEVIATION 93.1 • n=5 Participants	491.2 ng/mL STANDARD_DEVIATION 157.9 • n=7 Participants	399.8 ng/mL STANDARD_DEVIATION 116.7 • n=5 Participants	384.8 ng/mL STANDARD_DEVIATION 88.0 • n=4 Participants	373.7 ng/mL STANDARD_DEVIATION 96.0 • n=21 Participants	459.0 ng/mL STANDARD_DEVIATION 163.4 • n=8 Participants	382.5 ng/mL STANDARD_DEVIATION 82.7 • n=8 Participants	486.6 ng/mL STANDARD_DEVIATION 214.0 • n=24 Participants	478.5 ng/mL STANDARD_DEVIATION 94.0 • n=42 Participants	396.0 ng/mL STANDARD_DEVIATION 86.4 • n=42 Participants	432.0 ng/mL STANDARD_DEVIATION 133.6 • n=42 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until Day 85

Population: Safety analysis set

The relationship of each adverse event to the investigational product was assessed by the investigator.

A serious adverse event (SAE) is defined as an adverse event that

• is fatal
• is life threatening (places the subject at immediate risk of death)
• requires in-patient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability/incapacity
• is a congenital anomaly/birth defect
• other significant medical hazard.

Outcome measures

Measure	Placebo n=10 Participants Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 Participants Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 Participants Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 Participants Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 Participants Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Number of Participants With Adverse Events Deaths on study	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Any adverse event	7 participants	2 participants	5 participants	4 participants	6 participants	3 participants	1 participants	7 participants	1 participants	1 participants
Number of Participants With Adverse Events Treatment-related adverse events	1 participants	1 participants	0 participants	1 participants	6 participants	0 participants	1 participants	2 participants	0 participants	0 participants
Number of Participants With Adverse Events Serious adverse events	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Discontinuations due to adverse events	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From the first dose of study drug until Day 85

Population: Safety analysis set

Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies

Outcome measures

Measure	Placebo n=10 Participants Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 Participants Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 Participants Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 Participants Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 Participants Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Number of Participants With Anti-Evolocumab Antibodies Binding Antibodies	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-Evolocumab Antibodies Neutralizing Antibodies	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 1, predose and Days 4, 8, 15, 22, 29, 36, 40, 43, 50, 57, 64, 71, 78, and 85

Population: The Pharmacokinetic analysis set consisted of all participants for whom at least 1 pharmacokinetic parameter or endpoint could be adequately estimated. Serum evolocumab concentrations were not detectable in Cohorts 1 and 2.

Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 800 ng/mL.

Outcome measures

Measure	Placebo Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=9 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=4 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Maximum Observed Plasma Concentration (Cmax) of Evolocumab	—	—	20.3 μg/mL Standard Deviation 13.2	62.8 μg/mL Standard Deviation 22.7	63.6 μg/mL Standard Deviation 11.2	16.3 μg/mL Standard Deviation 10.8	14.7 μg/mL Standard Deviation 2.9	—	—	—

SECONDARY outcome

Timeframe: Day 29 predose (last dose for Cohorts 3-7) and Days 36 (predose for Cohorts 1 and 2), 40, 43, 50, 57, 64, 71, 78, and 85

Population: Pharmacokinetic analysis set with available data

Area under the unbound evolocumab serum concentration-time curve from time of last dose to time of last quantifiable concentration following the last dose of evolocumab.

Outcome measures

Measure	Placebo Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=8 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=4 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab	—	—	226 day*μg/mL Standard Deviation 249	1200 day*μg/mL Standard Deviation 634	903 day*μg/mL Standard Deviation 280	181 day*μg/mL Standard Deviation 157	165 day*μg/mL Standard Deviation 69	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group

Population: Participants with non-missing data

Outcome measures

Measure	Placebo n=10 Participants Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 Participants Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 Participants Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 Participants Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 Participants Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Percent Change From Baseline to End of the Dosing Interval in LDL-C	3.14 percent change Standard Deviation 33.73	-23.79 percent change Standard Deviation 21.57	-51.76 percent change Standard Deviation 18.29	-69.58 percent change Standard Deviation 18.13	-74.65 percent change Standard Deviation 3.47	-62.01 percent change Standard Deviation 11.43	-3.01 percent change Standard Deviation 3.09	-61.82 percent change Standard Deviation 17.67	-4.89 percent change Standard Deviation 0.82	-62.91 percent change Standard Deviation 16.04

SECONDARY outcome

Timeframe: Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group

Population: Participants with non-missing data

Serum PCSK9 concentrations were determined by using a qualified enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 15 ng/mL.

Outcome measures

Measure	Placebo n=10 Participants Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 Participants Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 Participants Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 Participants Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 Participants Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 Participants Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 Participants Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 Participants Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 Participants Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 Participants Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Percent Change From Baseline to End of the Dosing Interval in PCSK9	6.00 percent change Standard Deviation 25.49	-42.07 percent change Standard Deviation 16.99	-64.46 percent change Standard Deviation 3.70	-70.42 percent change Standard Deviation 16.05	-91.49 percent change Standard Deviation 6.45	-32.72 percent change Standard Deviation 29.41	43.60 percent change Standard Deviation 51.39	-62.50 percent change Standard Deviation 18.33	36.76 percent change Standard Deviation 12.54	-68.52 percent change Standard Deviation 10.67

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Evolocumab 14 mg QW × 6

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Evolocumab 35 mg QW × 6

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Evolocumab 140 mg Q2W × 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Evolocumab 280 mg Q2W × 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Evolocumab 420 mg Q4W × 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

High Dose Statin - Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

High Dose Statin - Evolocumab 140 mg Q2W × 3

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

HeFH - Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

HeFH - Evolocumab 140 mg Q2W × 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=10 participants at risk Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.	Evolocumab 14 mg QW × 6 n=6 participants at risk Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 35 mg QW × 6 n=6 participants at risk Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.	Evolocumab 140 mg Q2W × 3 n=6 participants at risk Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 280 mg Q2W × 3 n=6 participants at risk Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.	Evolocumab 420 mg Q4W × 2 n=6 participants at risk Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.	High Dose Statin - Placebo n=2 participants at risk Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.	High Dose Statin - Evolocumab 140 mg Q2W × 3 n=9 participants at risk Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Placebo n=2 participants at risk Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.	HeFH - Evolocumab 140 mg Q2W × 3 n=4 participants at risk Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Eosinophil count increased	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rhonchi	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dental caries	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 1/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Toothache	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site haematoma	20.0% 2/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site haemorrhage	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site pain	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral upper respiratory tract infection	10.0% 1/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Lipoma excision	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.1% 1/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose vein	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 1/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hypothyroidism	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dysphagia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Flatulence	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site reaction	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vessel puncture site pain	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Localised infection	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pharyngitis streptococcal	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Cardiac murmur	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Liver function test abnormal	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Gout	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysgeusia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/9 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From the first dose of study drug until Day 85 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER