Trial Outcomes & Findings for Romosozumab in Women With Chronic SCI (NCT NCT04708886)

NCT ID: NCT04708886

Last Updated: 2025-09-24

Results Overview

Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline - 12 months
• Results posted on: 2025-09-24

Participant Flow

Participant milestones

Measure	Females With Chronic SCI 12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg). Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Year 1: Romosozumab STARTED	12
Year 1: Romosozumab COMPLETED	12
Year 1: Romosozumab NOT COMPLETED	0
Year 2: Alendronate STARTED	12
Year 2: Alendronate COMPLETED	10
Year 2: Alendronate NOT COMPLETED	2

Reasons for withdrawal

Measure	Females With Chronic SCI 12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg). Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Year 2: Alendronate Lost to Follow-up	1
Year 2: Alendronate Withdrawal by Subject	1

Baseline Characteristics

Romosozumab in Women With Chronic SCI

Baseline characteristics by cohort

Measure	Open-label Romosozumab n=12 Participants Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - 12 months

Population: Females with Chronic SCI

Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.

Outcome measures

Measure	Females With Chronic SCI n=12 Participants Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months, followed by weekly oral alendronate (70 mg) for an additional 12 months. Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Change in Integral vBMC at the Knee (Distal Femur)	-0.78 g Interval -1.93 to -0.6

SECONDARY outcome

Timeframe: Baseline - 12 months

Population: Females with Chronic SCI

Change from baseline to the Month 12 visit in bone mineral density (BMD) obtained via DXA (two-dimensional) imaging of the total hip.

Outcome measures

Measure	Females With Chronic SCI n=12 Participants Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months, followed by weekly oral alendronate (70 mg) for an additional 12 months. Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Change in BMD at the Total Hip and Femoral Neck Total Hip	0.023 g/cm^2 Interval 0.016 to 0.033
Change in BMD at the Total Hip and Femoral Neck Femoral Neck	0.033 g/cm^2 Interval 0.008 to 0.049

SECONDARY outcome

Timeframe: Baseline - 12 months

Population: Females with Chronic SCI

Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT imaging of the hip.

Outcome measures

Measure	Females With Chronic SCI n=12 Participants Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months, followed by weekly oral alendronate (70 mg) for an additional 12 months. Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Change in vBMC at the Hip	0.063 g Interval -0.071 to 0.706

SECONDARY outcome

Timeframe: Baseline - 12 months

Population: Females with chronic SCI

Change from baseline to the Month 12 visit in serum levels of CTX and P1NP.

Outcome measures

Measure	Females With Chronic SCI n=12 Participants Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months, followed by weekly oral alendronate (70 mg) for an additional 12 months. Romosozumab was the investigational drug for Year 1; alendronate was administered as standard-of-care in Year 2.
Change in Serum Bone Biomarkers (CTX and P1NP) CTX	-0.0093 ng/mL Interval -0.048 to 0.025
Change in Serum Bone Biomarkers (CTX and P1NP) P1NP	-18.25 ng/mL Interval -23.56 to -4.27

Adverse Events

Year 1: Romosozumab

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Year 2: Alendronate

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Year 1: Romosozumab n=12 participants at risk Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months.	Year 2: Alendronate n=12 participants at risk Participants received alendronate (70 mg, oral, weekly) for an additional 12 months.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.

Other adverse events

Measure	Year 1: Romosozumab n=12 participants at risk Participants received monthly subcutaneous injections of romosozumab (210 mg) for 12 months.	Year 2: Alendronate n=12 participants at risk Participants received alendronate (70 mg, oral, weekly) for an additional 12 months.
General disorders Injection site reaction	66.7% 8/12 • Number of events 14 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Bone Pain	25.0% 3/12 • Number of events 3 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Renal and urinary disorders Urinary tract infection (UTI)	33.3% 4/12 • Number of events 5 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	16.7% 2/12 • Number of events 3 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Injury, poisoning and procedural complications Burn	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Wound infection	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Eye disorders Anisocoria	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Vascular disorders Hypotension	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Infections and infestations COVID-19 viral infection	41.7% 5/12 • Number of events 5 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	25.0% 3/12 • Number of events 3 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Nervous system disorders Spasticity	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 2/12 • Number of events 4 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Laceration	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Back pain	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Reproductive system and breast disorders Irregular menstruation	25.0% 3/12 • Number of events 3 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 4/12 • Number of events 4 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection (cold)	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
General disorders Edema, ankle	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Onycholysis of toe	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Vascular disorders Thromboembolic event (PE or DVT)	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Surgical and medical procedures Surgical site bleeding	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Injury, poisoning and procedural complications Left knee injury	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Nervous system disorders Neuralgia	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Blood and lymphatic system disorders Low phosphorous level	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Eye disorders Blurred vision	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Reproductive system and breast disorders Adenomyosis	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Injury, poisoning and procedural complications Bruising	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Nervous system disorders Peripheral neuropathy	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
General disorders Fatigue	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Nervous system disorders Headache	16.7% 2/12 • Number of events 3 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Bilateral ankle abrasions	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Skin infection	16.7% 2/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
General disorders Chills	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Right ankle sprain	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Abscess to left buttock	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Gastrointestinal disorders Gastroenteritis	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Right hip subluxation	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Respiratory, thoracic and mediastinal disorders Mild asthma exacerbation	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
General disorders Edema, limbs	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Cardiac disorders Aortic valve disease	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Musculoskeletal and connective tissue disorders Hemarthrosis of left knee	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Vascular disorders Cool right lower extremity	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Abrasions	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Renal and urinary disorders Bladder calculi	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Ear and labyrinth disorders Ear infection (otitis media)	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Respiratory, thoracic and mediastinal disorders Respiratory syncytial virus (RSV)	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Skin and subcutaneous tissue disorders Acne vulgaris of buttock	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 2 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Gastrointestinal disorders Heartburn/Acid Reflux	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Gastrointestinal disorders Hemorrhoids	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.
Injury, poisoning and procedural complications Fracture of ribs	0.00% 0/12 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.	8.3% 1/12 • Number of events 1 • 25 months Adverse events were obtained by asking participants about changes in their health status during the course of the study. A MedDRA database was used to document all adverse events. Reports of safety outcomes were generated for use by the data and safety monitoring committee (DSMC) to review. DSMC meetings occured at least every 6 months. All serious adverse events (SAEs) were reported as required to the local IRB, Amgen, and FDA.

Additional Information

Thomas Schnitzer

Northwestern University Feinberg School of Medicine

Phone: 3125032315

Email: tjs@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place