Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis (NCT NCT01992159)
NCT ID: NCT01992159
Last Updated: 2019-03-25
Results Overview
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
252 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-03-25
Participant Flow
This study was conducted at 24 centers in Japan. The first participant was enrolled on 12 October 2012 and the last participant enrolled on 15 October 2013.
Participants were randomized in a 1:1:1:1 ratio to receive placebo or romosozumab 70, 140, or 210 mg subcutaneous (SC) injection every month (QM) for 12 months. Upon completion of the 12-month treatment period, participants were followed for another 3 months for assessment of antiromosozumab antibody formation (follow-up period).
Participant milestones
| Measure |
Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
63
|
63
|
|
Overall Study
Received Treatment
|
63
|
63
|
63
|
63
|
|
Overall Study
Completed First 12 Months of Study
|
59
|
56
|
63
|
59
|
|
Overall Study
COMPLETED
|
59
|
55
|
62
|
59
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=63 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=63 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=63 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 7.2 • n=63 Participants
|
66.5 years
STANDARD_DEVIATION 6.3 • n=63 Participants
|
68.4 years
STANDARD_DEVIATION 6.0 • n=63 Participants
|
68.3 years
STANDARD_DEVIATION 5.9 • n=63 Participants
|
67.7 years
STANDARD_DEVIATION 6.4 • n=252 Participants
|
|
Age, Customized
< 65 years
|
27 Participants
n=63 Participants
|
30 Participants
n=63 Participants
|
18 Participants
n=63 Participants
|
18 Participants
n=63 Participants
|
93 Participants
n=252 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
22 Participants
n=63 Participants
|
22 Participants
n=63 Participants
|
34 Participants
n=63 Participants
|
34 Participants
n=63 Participants
|
112 Participants
n=252 Participants
|
|
Age, Customized
≥ 75 years
|
14 Participants
n=63 Participants
|
11 Participants
n=63 Participants
|
11 Participants
n=63 Participants
|
11 Participants
n=63 Participants
|
47 Participants
n=252 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
252 Participants
n=252 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Asian
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
63 Participants
n=63 Participants
|
252 Participants
n=252 Participants
|
|
Lumbar Spine Bone Mineral Density (BMD) T-score
|
-2.69 T-score
STANDARD_DEVIATION 0.52 • n=63 Participants
|
-2.73 T-score
STANDARD_DEVIATION 0.57 • n=63 Participants
|
-2.65 T-score
STANDARD_DEVIATION 0.66 • n=63 Participants
|
-2.72 T-score
STANDARD_DEVIATION 0.42 • n=63 Participants
|
-2.70 T-score
STANDARD_DEVIATION 0.54 • n=252 Participants
|
|
Total Hip BMD T-score
|
-2.00 T-score
STANDARD_DEVIATION 0.60 • n=63 Participants
|
-1.97 T-score
STANDARD_DEVIATION 0.57 • n=63 Participants
|
-1.85 T-score
STANDARD_DEVIATION 0.68 • n=63 Participants
|
-1.95 T-score
STANDARD_DEVIATION 0.65 • n=63 Participants
|
-1.94 T-score
STANDARD_DEVIATION 0.63 • n=252 Participants
|
|
Femoral Neck BMD T-score
|
-2.31 T-score
STANDARD_DEVIATION 0.47 • n=63 Participants
|
-2.27 T-score
STANDARD_DEVIATION 0.53 • n=63 Participants
|
-2.28 T-score
STANDARD_DEVIATION 0.65 • n=63 Participants
|
-2.32 T-score
STANDARD_DEVIATION 0.59 • n=63 Participants
|
-2.29 T-score
STANDARD_DEVIATION 0.56 • n=252 Participants
|
|
Serum Procollagen Type 1 N-telopeptide (P1NP)
|
52.4 μg/L
n=63 Participants • Participants with available data
|
51.9 μg/L
n=62 Participants • Participants with available data
|
47.6 μg/L
n=63 Participants • Participants with available data
|
50.9 μg/L
n=63 Participants • Participants with available data
|
50.5 μg/L
n=251 Participants • Participants with available data
|
|
Serum Type 1 Collagen C-telopeptide (CTX)
|
441.0 ng/L
n=63 Participants
|
441.0 ng/L
n=63 Participants
|
374.0 ng/L
n=63 Participants
|
420.0 ng/L
n=63 Participants
|
412.0 ng/L
n=252 Participants
|
|
Osteocalcin
|
22.17 μg/L
n=63 Participants
|
22.50 μg/L
n=63 Participants
|
21.01 μg/L
n=63 Participants
|
22.75 μg/L
n=63 Participants
|
22.03 μg/L
n=252 Participants
|
|
Bone Specific Alkaline Phosphatase (BSAP)
|
14.49 μg/L
n=63 Participants • Participants with available data
|
13.92 μg/L
n=62 Participants • Participants with available data
|
15.49 μg/L
n=63 Participants • Participants with available data
|
14.72 μg/L
n=63 Participants • Participants with available data
|
14.72 μg/L
n=251 Participants • Participants with available data
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement (primary efficacy subset).
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
|
0.9 percent change
Interval 0.1 to 1.8
|
8.4 percent change
Interval 7.6 to 9.3
|
13.3 percent change
Interval 12.1 to 14.5
|
16.9 percent change
Interval 15.5 to 18.4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
|
1.2 percent change
Interval 0.5 to 1.9
|
6.5 percent change
Interval 5.7 to 7.2
|
10.2 percent change
Interval 9.2 to 11.2
|
13.1 percent change
Interval 11.7 to 14.5
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
|
0.6 percent change
Interval 0.0 to 1.3
|
1.2 percent change
Interval 0.5 to 2.0
|
2.3 percent change
Interval 1.7 to 2.9
|
3.2 percent change
Interval 2.5 to 3.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.
Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
|
0.6 percent change
Interval 0.0 to 1.3
|
2.1 percent change
Interval 1.4 to 2.8
|
3.2 percent change
Interval 2.6 to 3.9
|
4.7 percent change
Interval 4.0 to 5.5
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
|
0.6 percent change
Interval -0.1 to 1.4
|
1.0 percent change
Interval 0.1 to 1.8
|
1.9 percent change
Interval 1.0 to 2.9
|
3.3 percent change
Interval 2.1 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
|
0.3 percent change
Interval -0.6 to 1.2
|
1.9 percent change
Interval 1.0 to 2.7
|
2.9 percent change
Interval 2.1 to 3.8
|
3.8 percent change
Interval 2.7 to 4.9
|
SECONDARY outcome
Timeframe: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12Population: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement and with available data at each time point.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Week 1
|
-2.5 percent change
Standard Deviation 9.0
|
43.4 percent change
Standard Deviation 24.0
|
65.9 percent change
Standard Deviation 25.7
|
81.5 percent change
Standard Deviation 34.6
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 1
|
-5.7 percent change
Standard Deviation 22.1
|
32.2 percent change
Standard Deviation 22.9
|
79.8 percent change
Standard Deviation 41.7
|
101.6 percent change
Standard Deviation 41.1
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 2
|
-10.9 percent change
Standard Deviation 18.5
|
-0.7 percent change
Standard Deviation 18.4
|
34.6 percent change
Standard Deviation 38.2
|
59.8 percent change
Standard Deviation 40.5
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 3
|
-11.5 percent change
Standard Deviation 20.3
|
-13.1 percent change
Standard Deviation 18.3
|
14.9 percent change
Standard Deviation 32.2
|
25.5 percent change
Standard Deviation 33.4
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 6
|
-8.9 percent change
Standard Deviation 23.3
|
-16.8 percent change
Standard Deviation 26.0
|
-2.7 percent change
Standard Deviation 28.0
|
2.4 percent change
Standard Deviation 24.8
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 9
|
-2.1 percent change
Standard Deviation 32.0
|
-16.9 percent change
Standard Deviation 31.3
|
-9.1 percent change
Standard Deviation 30.9
|
-4.0 percent change
Standard Deviation 31.5
|
|
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Month 12
|
4.6 percent change
Standard Deviation 37.9
|
-11.1 percent change
Standard Deviation 29.8
|
-16.2 percent change
Standard Deviation 27.4
|
-13.1 percent change
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12Population: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Week 1
|
11.9 percent change
Standard Deviation 27.8
|
-28.0 percent change
Standard Deviation 25.8
|
-32.1 percent change
Standard Deviation 32.8
|
-42.0 percent change
Standard Deviation 25.4
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 1
|
14.9 percent change
Standard Deviation 40.2
|
-18.0 percent change
Standard Deviation 34.3
|
-8.0 percent change
Standard Deviation 53.9
|
-24.6 percent change
Standard Deviation 30.5
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 2
|
14.1 percent change
Standard Deviation 41.6
|
-2.3 percent change
Standard Deviation 48.4
|
14.9 percent change
Standard Deviation 67.8
|
0.1 percent change
Standard Deviation 49.1
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 3
|
16.1 percent change
Standard Deviation 49.0
|
-5.5 percent change
Standard Deviation 48.3
|
28.9 percent change
Standard Deviation 84.1
|
8.1 percent change
Standard Deviation 53.8
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 6
|
13.6 percent change
Standard Deviation 49.8
|
-10.8 percent change
Standard Deviation 52.2
|
3.2 percent change
Standard Deviation 71.8
|
-13.4 percent change
Standard Deviation 40.6
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 9
|
12.6 percent change
Standard Deviation 56.6
|
-13.2 percent change
Standard Deviation 53.0
|
-8.0 percent change
Standard Deviation 55.7
|
-15.3 percent change
Standard Deviation 44.8
|
|
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Month 12
|
35.4 percent change
Standard Deviation 81.7
|
-4.1 percent change
Standard Deviation 47.2
|
2.1 percent change
Standard Deviation 73.5
|
-10.5 percent change
Standard Deviation 53.8
|
SECONDARY outcome
Timeframe: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12Population: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Osteocalcin
Month 9
|
-8.4 percent change
Standard Deviation 18.2
|
-6.8 percent change
Standard Deviation 22.5
|
-0.9 percent change
Standard Deviation 24.0
|
-1.3 percent change
Standard Deviation 18.9
|
|
Percent Change From Baseline in Osteocalcin
Month 12
|
-6.8 percent change
Standard Deviation 20.6
|
-8.6 percent change
Standard Deviation 21.8
|
-9.4 percent change
Standard Deviation 22.1
|
-8.9 percent change
Standard Deviation 17.9
|
|
Percent Change From Baseline in Osteocalcin
Week 1
|
2.6 percent change
Standard Deviation 18.1
|
6.5 percent change
Standard Deviation 12.6
|
7.9 percent change
Standard Deviation 17.0
|
5.5 percent change
Standard Deviation 14.5
|
|
Percent Change From Baseline in Osteocalcin
Month 1
|
-3.8 percent change
Standard Deviation 12.7
|
26.5 percent change
Standard Deviation 20.4
|
51.2 percent change
Standard Deviation 31.9
|
66.4 percent change
Standard Deviation 31.3
|
|
Percent Change From Baseline in Osteocalcin
Month 2
|
-7.0 percent change
Standard Deviation 13.4
|
13.7 percent change
Standard Deviation 15.1
|
39.3 percent change
Standard Deviation 31.6
|
48.9 percent change
Standard Deviation 31.6
|
|
Percent Change From Baseline in Osteocalcin
Month 3
|
-7.2 percent change
Standard Deviation 16.8
|
4.9 percent change
Standard Deviation 17.5
|
28.4 percent change
Standard Deviation 29.7
|
27.5 percent change
Standard Deviation 22.3
|
|
Percent Change From Baseline in Osteocalcin
Month 6
|
-10.3 percent change
Standard Deviation 15.9
|
-5.5 percent change
Standard Deviation 18.8
|
10.6 percent change
Standard Deviation 24.7
|
9.3 percent change
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12Population: Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=55 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=59 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Week 1
|
1.6 percent change
Standard Deviation 13.4
|
14.0 percent change
Standard Deviation 14.5
|
17.0 percent change
Standard Deviation 16.4
|
20.1 percent change
Standard Deviation 17.9
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 1
|
-0.5 percent change
Standard Deviation 22.1
|
23.0 percent change
Standard Deviation 19.9
|
51.3 percent change
Standard Deviation 27.6
|
66.2 percent change
Standard Deviation 31.9
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 2
|
-7.8 percent change
Standard Deviation 16.9
|
8.7 percent change
Standard Deviation 20.8
|
31.8 percent change
Standard Deviation 27.9
|
55.1 percent change
Standard Deviation 31.0
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 3
|
-9.5 percent change
Standard Deviation 16.3
|
-2.8 percent change
Standard Deviation 14.9
|
23.5 percent change
Standard Deviation 26.5
|
39.6 percent change
Standard Deviation 33.2
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 6
|
-6.6 percent change
Standard Deviation 20.5
|
-9.0 percent change
Standard Deviation 19.0
|
3.1 percent change
Standard Deviation 21.6
|
13.2 percent change
Standard Deviation 26.8
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 9
|
-7.0 percent change
Standard Deviation 20.5
|
-10.7 percent change
Standard Deviation 21.7
|
-2.6 percent change
Standard Deviation 25.3
|
3.5 percent change
Standard Deviation 23.8
|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Month 12
|
-6.3 percent change
Standard Deviation 22.7
|
-13.2 percent change
Standard Deviation 19.9
|
-13.7 percent change
Standard Deviation 23.3
|
-9.3 percent change
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.Population: Randomized participants who received at least 10 doses of the assigned randomized treatment, had never received any dose of incorrect treatment, and had no missing P1NP measurements.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=54 Participants
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=62 Participants
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=58 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Area Under the Curve Through Month 12 of P1NP
|
554.5 ug*month/L
Interval 523.0 to 585.9
|
539.2 ug*month/L
Interval 506.4 to 572.0
|
638.5 ug*month/L
Interval 607.9 to 669.2
|
708.3 ug*month/L
Interval 676.6 to 740.0
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Romosozumab 70 mg
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Romosozumab 140 mg
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Romosozumab 210 mg
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=63 participants at risk
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=63 participants at risk
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=63 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
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)
Breast cancer
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Heat illness
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 70 mg
n=63 participants at risk
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 140 mg
n=63 participants at risk
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Romosozumab 210 mg
n=63 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
3/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dental caries
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
3/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
8/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
27.0%
17/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
27.0%
17/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
31.7%
20/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.9%
5/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.5%
6/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
3/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
5/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
3/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
4/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
5/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
3.2%
2/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
5/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
1/63 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
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