Trial Outcomes & Findings for A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) (NCT NCT04480463)

NCT ID: NCT04480463

Last Updated: 2023-10-10

Results Overview

Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2023-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	SCD411 SCD411: IVT (intravitreal) injection	Aflibercept Aflibercept: IVT injection
Overall Study STARTED	288	288
Overall Study COMPLETED	259	256
Overall Study NOT COMPLETED	29	32

Reasons for withdrawal

Reasons for withdrawal
Measure	SCD411 SCD411: IVT (intravitreal) injection	Aflibercept Aflibercept: IVT injection
Overall Study Death	0	1
Overall Study Adverse Event	6	8
Overall Study Lost to Follow-up	3	2
Overall Study Physician Decision	2	5
Overall Study Decision by the sponsor or administrative decision for a reason other than that of an AE	2	3
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	6	7
Overall Study Subject missed any of first 2 doses (IVT I injection of IP at Day 1 or Week 4) after randomization	0	1
Overall Study A decrease in BCVA of ≥30 letters compared with the last assessment of VA	1	0
Overall Study Subretinal hemorrhage involving center of fovea or, size of hemorrhage was ≥50% of total lesion area	1	0
Overall Study Other	6	4

Baseline Characteristics

A subject from the SCD411 group had missing vital sign data (including body weight and height)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCD411 n=287 Participants SCD411: IVT (intravitreal) injection	Aflibercept n=286 Participants Aflibercept: IVT injection	Total n=573 Participants Total of all reporting groups
Age, Continuous	73.5 years STANDARD_DEVIATION 8 • n=287 Participants	73.6 years STANDARD_DEVIATION 8.55 • n=286 Participants	73.5 years STANDARD_DEVIATION 8.27 • n=573 Participants
Age, Customized 50 to less than 65 years	33 Participants n=287 Participants	40 Participants n=286 Participants	73 Participants n=573 Participants
Age, Customized 65 to less than 75 years	131 Participants n=287 Participants	119 Participants n=286 Participants	250 Participants n=573 Participants
Age, Customized Greater than or equal to 75 years	123 Participants n=287 Participants	127 Participants n=286 Participants	250 Participants n=573 Participants
Sex: Female, Male Female	149 Participants n=287 Participants	147 Participants n=286 Participants	296 Participants n=573 Participants
Sex: Female, Male Male	138 Participants n=287 Participants	139 Participants n=286 Participants	277 Participants n=573 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=287 Participants	10 Participants n=286 Participants	19 Participants n=573 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	278 Participants n=287 Participants	276 Participants n=286 Participants	554 Participants n=573 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=287 Participants	0 Participants n=286 Participants	0 Participants n=573 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=287 Participants	1 Participants n=286 Participants	2 Participants n=573 Participants
Race (NIH/OMB) Asian	97 Participants n=287 Participants	90 Participants n=286 Participants	187 Participants n=573 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=287 Participants	0 Participants n=286 Participants	0 Participants n=573 Participants
Race (NIH/OMB) Black or African American	1 Participants n=287 Participants	1 Participants n=286 Participants	2 Participants n=573 Participants
Race (NIH/OMB) White	188 Participants n=287 Participants	194 Participants n=286 Participants	382 Participants n=573 Participants
Race (NIH/OMB) More than one race	0 Participants n=287 Participants	0 Participants n=286 Participants	0 Participants n=573 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=287 Participants	0 Participants n=286 Participants	0 Participants n=573 Participants
Region of Enrollment Australia	7 participants n=287 Participants	6 participants n=286 Participants	13 participants n=573 Participants
Region of Enrollment Bulgaria	2 participants n=287 Participants	2 participants n=286 Participants	4 participants n=573 Participants
Region of Enrollment Czechia	3 participants n=287 Participants	3 participants n=286 Participants	6 participants n=573 Participants
Region of Enrollment Hungary	22 participants n=287 Participants	17 participants n=286 Participants	39 participants n=573 Participants
Region of Enrollment India	8 participants n=287 Participants	1 participants n=286 Participants	9 participants n=573 Participants
Region of Enrollment Israel	42 participants n=287 Participants	42 participants n=286 Participants	84 participants n=573 Participants
Region of Enrollment Japan	30 participants n=287 Participants	30 participants n=286 Participants	60 participants n=573 Participants
Region of Enrollment Latvia	10 participants n=287 Participants	13 participants n=286 Participants	23 participants n=573 Participants
Region of Enrollment Poland	37 participants n=287 Participants	50 participants n=286 Participants	87 participants n=573 Participants
Region of Enrollment South Korea	59 participants n=287 Participants	59 participants n=286 Participants	118 participants n=573 Participants
Region of Enrollment Russia	12 participants n=287 Participants	10 participants n=286 Participants	22 participants n=573 Participants
Region of Enrollment Slovakia	16 participants n=287 Participants	13 participants n=286 Participants	29 participants n=573 Participants
Region of Enrollment Spain	20 participants n=287 Participants	24 participants n=286 Participants	44 participants n=573 Participants
Region of Enrollment United States	19 participants n=287 Participants	16 participants n=286 Participants	35 participants n=573 Participants
Weight	72.39 kilograms STANDARD_DEVIATION 15.244 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	72.26 kilograms STANDARD_DEVIATION 12.280 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	72.32 kilograms STANDARD_DEVIATION 14.757 • n=572 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)
Height	164.02 centimeters STANDARD_DEVIATION 9.117 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	164.64 centimeters STANDARD_DEVIATION 8.976 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	164.33 centimeters STANDARD_DEVIATION 9.045 • n=572 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)
BMI	26.81 kg/m^2 STANDARD_DEVIATION 4.682 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	26.53 kg/m^2 STANDARD_DEVIATION 4.154 • n=286 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)	26.67 kg/m^2 STANDARD_DEVIATION 4.424 • n=572 Participants • A subject from the SCD411 group had missing vital sign data (including body weight and height)
Best Corrected Visual Acuity (BCVA)	58.6 Letters correctly read STANDARD_DEVIATION 10.75 • n=287 Participants	59.9 Letters correctly read STANDARD_DEVIATION 10.60 • n=286 Participants	59.3 Letters correctly read STANDARD_DEVIATION 10.69 • n=573 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: The Full Analysis Set included all randomized subjects who received at least 1 injection of the study drug.

Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

Outcome measures

Outcome measures
Measure	SCD411 n=287 Participants SCD411: IVT (intravitreal) injection	Aflibercept n=286 Participants Aflibercept: IVT injection
Change From Baseline in BCVA (Best Corrected Visual Acuity)	5.5 Letters correctly read Interval 4.5 to 6.5	5.9 Letters correctly read Interval 4.8 to 6.9

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: The Full Analysis Set included all randomized subjects who received at least 1 injection of the study drug.

Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

Outcome measures

Outcome measures
Measure	SCD411 n=287 Participants SCD411: IVT (intravitreal) injection	Aflibercept n=286 Participants Aflibercept: IVT injection
Change From Baseline in BCVA (Best Corrected Visual Acuity)	9.0 Letters correctly read Interval 7.6 to 10.4	7.7 Letters correctly read Interval 6.3 to 9.1

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 20, 36 and 52

Population: The Safety Set included all subjects who received at least 1 injection of the study drug.

Assessed by blood samples

Outcome measures

Outcome measures
Measure	SCD411 n=287 Participants SCD411: IVT (intravitreal) injection	Aflibercept Aflibercept: IVT injection
Percentage of Subjects With Anti-SCD411 Antibodies Week 52 : Positive	20.2 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Baseline : Positive	7.1 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Baseline : Negative	92.9 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 4 : Positive	29.4 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 4 : Negative	70.6 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 8 : Positive	40.0 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 8 : Negative	60.0 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 20 : Positive	39.6 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 20 : Negative	60.4 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 36 : Positive	22.9 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 36 : Negative	77.1 Percentage of participants	—
Percentage of Subjects With Anti-SCD411 Antibodies Week 52 : Negative	79.8 Percentage of participants	—

Adverse Events

SCD411

Serious events: 32 serious events

Other events: 128 other events

Deaths: 0 deaths

Aflibercept

Serious events: 30 serious events

Other events: 121 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Byung Jhip Ha, Director of Bio Research Center

SamChunDang Pharm. Co. Ltd.

Phone: +82-31-869-7327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SCD411 n=287 participants at risk SCD411: IVT (intravitreal) injection	Aflibercept n=286 participants at risk Aflibercept: IVT injection
Cardiac disorders Angina pectoris	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Cardiac disorders Atrial fibrillation	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Ear and labyrinth disorders Tinnitus	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Age-related macular degeneration	0.70% 2/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Blepharitis	0.35% 1/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Cataract	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Conjunctival haemorrhage	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Corneal erosion	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Dry eye	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Eye pain	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Lacrimation increased	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Neovascular age-related macular degeneration	7.0% 20/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	4.5% 13/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Ocular hypertension	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Posterior capsule opacification	1.4% 4/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Punctate keratitis	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.70% 2/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Retinal haemorrhage	0.35% 1/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Subretinal fluid	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Visual acuity reduced	3.8% 11/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	4.2% 12/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Visual impairment	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.00% 0/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Vitreous detachment	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Eye disorders Vitreous floaters	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Abdominal pain	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Diarrhoea	0.35% 1/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Dyspepsia	1.4% 4/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.00% 0/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Gastritis	0.35% 1/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Inguinal hernia	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Nausea	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Gastrointestinal disorders Vomiting	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations COVID-19	5.6% 16/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	7.3% 21/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Conjunctivitis	2.4% 7/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.70% 2/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Gastroenteritis	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.00% 0/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Nasopharyngitis	2.1% 6/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Sinusitis	1.4% 4/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Tooth abscess	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.00% 0/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Infections and infestations Urinary tract infection	3.5% 10/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	2.4% 7/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Investigations Intraocular pressure increased	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	2.1% 6/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Musculoskeletal and connective tissue disorders Back pain	3.1% 9/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	3.5% 10/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.7% 5/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.35% 1/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 3/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Nervous system disorders Dizziness	0.70% 2/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Nervous system disorders Headache	1.4% 4/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.0% 3/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 4/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	0.00% 0/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
Vascular disorders Hypertension	3.8% 11/287 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.	1.4% 4/286 • Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.