Trial Outcomes & Findings for A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785) (NCT NCT01825785)
NCT ID: NCT01825785
Last Updated: 2023-08-30
Results Overview
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
169 days
Results posted on
2023-08-30
Participant Flow
This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.
Participants were enrolled into 1 of 6 cohorts. In each of cohorts 1 to 4, healthy postmenopausal women were randomized in a 3:1 ratio to receive romosozumab or placebo; In each of cohorts 5 and 6, healthy men were randomized in a 3:1 ratio to receive romosozumab or placebo.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
6
|
4
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
54.3 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
61.2 years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
59.3 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
58.7 years
STANDARD_DEVIATION 8.0 • n=24 Participants
|
|
Age, Customized
18 to 64 years
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Age, Customized
65 to 74 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Age, Customized
≥ 75 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 169 daysPopulation: All treated participants
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
10 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
6 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Discontinuation due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Death on study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169.Population: All treated participants
All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Antibodies to Romosozumab
Neutralizing antibodies
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Developed Antibodies to Romosozumab
Binding antibodies
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=5 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=5 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Romosozumab
First dose
|
3.0 days
Interval 2.0 to 5.0
|
3.0 days
Interval 3.0 to 5.0
|
4.5 days
Interval 3.0 to 7.0
|
3.0 days
Interval 3.0 to 5.0
|
3.0 days
Interval 3.0 to 5.0
|
5.0 days
Interval 3.0 to 5.0
|
—
|
|
Time to Maximum Observed Concentration (Tmax) of Romosozumab
Last dose
|
3.0 days
Interval 3.0 to 5.0
|
3.0 days
Interval 1.0 to 4.0
|
3.5 days
Interval 3.0 to 5.0
|
5.0 days
Interval 2.0 to 7.0
|
3.0 days
Interval 3.0 to 5.0
|
3.0 days
Interval 3.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=5 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=5 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Romosozumab
Last dose
|
14.2 μg/mL
Standard Deviation 4.3
|
16.7 μg/mL
Standard Deviation 3.3
|
27.8 μg/mL
Standard Deviation 8.4
|
29.5 μg/mL
Standard Deviation 8.7
|
13.4 μg/mL
Standard Deviation 4.4
|
37.1 μg/mL
Standard Deviation 8.1
|
—
|
|
Maximum Observed Concentration (Cmax) of Romosozumab
First dose
|
6.80 μg/mL
Standard Deviation 1.86
|
15.7 μg/mL
Standard Deviation 4.6
|
14.8 μg/mL
Standard Deviation 6.0
|
24.5 μg/mL
Standard Deviation 6.8
|
8.06 μg/mL
Standard Deviation 1.57
|
27.7 μg/mL
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=5 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=5 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab
First dose
|
65.5 μg*day/mL
Standard Deviation 15.6
|
202 μg*day/mL
Standard Deviation 48
|
152 μg*day/mL
Standard Deviation 63
|
340 μg*day/mL
Standard Deviation 73
|
71.3 μg*day/mL
Standard Deviation 11.8
|
434 μg*day/mL
Standard Deviation 81
|
—
|
|
Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab
Last dose
|
141 μg*day/mL
Standard Deviation 41
|
231 μg*day/mL
Standard Deviation 58
|
321 μg*day/mL
Standard Deviation 97
|
462 μg*day/mL
Standard Deviation 97
|
136 μg*day/mL
Standard Deviation 42
|
555 μg*day/mL
Standard Deviation 181
|
—
|
SECONDARY outcome
Timeframe: Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169.Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=5 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=5 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab
|
7.02 days
Standard Deviation 3.52
|
6.51 days
Standard Deviation 1.37
|
9.32 days
Standard Deviation 1.88
|
6.84 days
Standard Deviation 1.79
|
6.77 days
Standard Deviation 1.92
|
6.07 days
Standard Deviation 1.50
|
—
|
SECONDARY outcome
Timeframe: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.Population: All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=4 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=5 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (AR) for Romosozumab
|
2.15 ratio
Standard Deviation 0.45
|
1.17 ratio
Standard Deviation 0.26
|
2.35 ratio
Standard Deviation 0.90
|
1.35 ratio
Standard Deviation 0.19
|
1.90 ratio
Standard Deviation 0.49
|
1.26 ratio
Standard Deviation 0.23
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Day 85
|
-0.843 percent change
Standard Error 0.829
|
3.579 percent change
Standard Error 1.942
|
3.881 percent change
Standard Error 1.437
|
3.853 percent change
Standard Error 0.543
|
3.146 percent change
Standard Error 2.027
|
3.135 percent change
Standard Error 1.085
|
4.157 percent change
Standard Error 0.714
|
|
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Day 127
|
0.177 percent change
Standard Error 0.907
|
4.313 percent change
Standard Error 3.057
|
7.219 percent change
Standard Error 1.243
|
6.350 percent change
Standard Error 0.732
|
5.566 percent change
Standard Error 2.142
|
4.462 percent change
Standard Error 1.787
|
5.599 percent change
Standard Error 0.756
|
|
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Day 29
|
-0.046 percent change
Standard Error 0.778
|
2.161 percent change
Standard Error 0.177
|
0.541 percent change
Standard Error 1.296
|
-0.495 percent change
Standard Error 0.930
|
-0.257 percent change
Standard Error 0.623
|
2.662 percent change
Standard Error 0.804
|
-0.660 percent change
Standard Error 1.240
|
|
Percent Change From Baseline in Bone Mineral Density of the Total Spine
Day 169
|
-0.559 percent change
Standard Error 1.013
|
4.769 percent change
Standard Error 1.916
|
4.835 percent change
Standard Error 1.116
|
5.250 percent change
Standard Error 1.630
|
4.980 percent change
Standard Error 2.111
|
5.187 percent change
Standard Error 0.825
|
6.560 percent change
Standard Error 1.293
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Day 29
|
-0.552 percent change
Standard Error 0.347
|
0.528 percent change
Standard Error 0.617
|
-0.768 percent change
Standard Error 0.334
|
0.112 percent change
Standard Error 0.940
|
-0.318 percent change
Standard Error 1.182
|
1.244 percent change
Standard Error 1.368
|
-0.902 percent change
Standard Error 0.408
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Day 85
|
-0.613 percent change
Standard Error 0.529
|
1.066 percent change
Standard Error 0.938
|
0.639 percent change
Standard Error 0.608
|
2.116 percent change
Standard Error 0.477
|
2.088 percent change
Standard Error 0.550
|
1.134 percent change
Standard Error 0.797
|
0.731 percent change
Standard Error 0.621
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Day 127
|
-0.793 percent change
Standard Error 0.623
|
0.702 percent change
Standard Error 1.180
|
0.621 percent change
Standard Error 0.940
|
2.855 percent change
Standard Error 0.778
|
3.996 percent change
Standard Error 1.109
|
2.111 percent change
Standard Error 0.486
|
1.455 percent change
Standard Error 0.669
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Hip
Day 169
|
-0.511 percent change
Standard Error 0.380
|
1.423 percent change
Standard Error 1.047
|
0.894 percent change
Standard Error 1.013
|
3.176 percent change
Standard Error 1.105
|
2.094 percent change
Standard Error 0.751
|
1.007 percent change
Standard Error 0.422
|
0.370 percent change
Standard Error 0.629
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Day 29
|
-0.394 percent change
Standard Error 0.573
|
0.300 percent change
Standard Error 0.813
|
-2.172 percent change
Standard Error 1.331
|
-0.811 percent change
Standard Error 1.596
|
-0.473 percent change
Standard Error 1.987
|
0.471 percent change
Standard Error 1.919
|
-0.597 percent change
Standard Error 0.839
|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Day 85
|
-1.175 percent change
Standard Error 1.042
|
1.360 percent change
Standard Error 1.031
|
0.578 percent change
Standard Error 1.285
|
-0.123 percent change
Standard Error 1.001
|
0.270 percent change
Standard Error 1.176
|
1.301 percent change
Standard Error 0.681
|
1.956 percent change
Standard Error 1.493
|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Day 169
|
-0.447 percent change
Standard Error 0.673
|
0.801 percent change
Standard Error 1.208
|
-0.672 percent change
Standard Error 1.783
|
0.510 percent change
Standard Error 1.103
|
2.197 percent change
Standard Error 1.674
|
1.665 percent change
Standard Error 1.582
|
0.116 percent change
Standard Error 2.003
|
|
Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Day 127
|
-2.301 percent change
Standard Error 0.745
|
1.284 percent change
Standard Error 1.255
|
-1.005 percent change
Standard Error 2.609
|
1.471 percent change
Standard Error 1.228
|
1.332 percent change
Standard Error 2.488
|
1.861 percent change
Standard Error 1.208
|
0.091 percent change
Standard Error 1.110
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Day 85
|
0.609 percent change
Standard Error 0.943
|
-0.082 percent change
Standard Error 1.012
|
-2.740 percent change
Standard Error 0.770
|
0.803 percent change
Standard Error 1.411
|
-4.125 percent change
Standard Error 0.421
|
-2.504 percent change
Standard Error 1.777
|
-0.993 percent change
Standard Error 1.478
|
|
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Day 29
|
1.676 percent change
Standard Error 0.897
|
-0.220 percent change
Standard Error 0.998
|
-0.900 percent change
Standard Error 0.733
|
-2.052 percent change
Standard Error 1.295
|
-2.968 percent change
Standard Error 0.930
|
-0.435 percent change
Standard Error 1.078
|
-1.185 percent change
Standard Error 1.101
|
|
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Day 127
|
0.835 percent change
Standard Error 0.988
|
0.680 percent change
Standard Error 1.345
|
-1.037 percent change
Standard Error 0.668
|
0.633 percent change
Standard Error 1.450
|
-4.739 percent change
Standard Error 0.642
|
-1.756 percent change
Standard Error 1.158
|
-2.263 percent change
Standard Error 1.227
|
|
Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Day 169
|
-0.191 percent change
Standard Error 0.753
|
0.522 percent change
Standard Error 1.835
|
0.240 percent change
Standard Error 1.068
|
-0.028 percent change
Standard Error 1.943
|
-3.647 percent change
Standard Error 0.924
|
-1.836 percent change
Standard Error 1.145
|
-1.449 percent change
Standard Error 1.106
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Day 169
|
0.417 percent change
Standard Error 0.768
|
-1.102 percent change
Standard Error 1.834
|
-0.928 percent change
Standard Error 0.717
|
-0.234 percent change
Standard Error 1.126
|
-2.632 percent change
Standard Error 1.466
|
-0.378 percent change
Standard Error 0.818
|
-0.211 percent change
Standard Error 0.619
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Day 29
|
0.135 percent change
Standard Error 0.529
|
-0.552 percent change
Standard Error 1.134
|
-0.014 percent change
Standard Error 0.591
|
-0.020 percent change
Standard Error 0.944
|
-0.438 percent change
Standard Error 1.054
|
0.757 percent change
Standard Error 0.698
|
0.021 percent change
Standard Error 0.479
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Day 85
|
0.329 percent change
Standard Error 0.604
|
-0.063 percent change
Standard Error 1.269
|
-0.754 percent change
Standard Error 0.533
|
0.448 percent change
Standard Error 0.549
|
-3.621 percent change
Standard Error 1.424
|
-0.306 percent change
Standard Error 0.510
|
0.160 percent change
Standard Error 0.296
|
|
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Day 127
|
0.236 percent change
Standard Error 0.563
|
-1.134 percent change
Standard Error 1.388
|
0.493 percent change
Standard Error 0.792
|
-0.739 percent change
Standard Error 0.595
|
-3.326 percent change
Standard Error 1.895
|
-0.914 percent change
Standard Error 0.338
|
-1.019 percent change
Standard Error 0.647
|
SECONDARY outcome
Timeframe: Baseline and days 29, 85, 127, and 169Population: Treated participants with available data at baseline and each time point
Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Day 29
|
-0.391 percent change
Standard Error 0.347
|
0.493 percent change
Standard Error 0.580
|
-1.122 percent change
Standard Error 0.885
|
-0.532 percent change
Standard Error 0.188
|
0.521 percent change
Standard Error 0.567
|
-0.058 percent change
Standard Error 0.387
|
-0.611 percent change
Standard Error 0.344
|
|
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Day 127
|
0.000 percent change
Standard Error 0.371
|
-1.068 percent change
Standard Error 0.357
|
-0.486 percent change
Standard Error 0.938
|
1.442 percent change
Standard Error 0.862
|
0.513 percent change
Standard Error 0.600
|
1.919 percent change
Standard Error 0.839
|
0.012 percent change
Standard Error 0.562
|
|
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Day 169
|
-0.352 percent change
Standard Error 0.320
|
0.180 percent change
Standard Error 1.143
|
-0.294 percent change
Standard Error 0.597
|
1.284 percent change
Standard Error 0.637
|
0.801 percent change
Standard Error 0.523
|
1.285 percent change
Standard Error 0.264
|
0.218 percent change
Standard Error 0.819
|
|
Percent Change From Baseline in Bone Mineral Density of the Whole Body
Day 85
|
0.103 percent change
Standard Error 0.391
|
0.259 percent change
Standard Error 0.642
|
-0.324 percent change
Standard Error 0.827
|
1.359 percent change
Standard Error 0.276
|
-0.151 percent change
Standard Error 0.614
|
0.459 percent change
Standard Error 0.271
|
0.243 percent change
Standard Error 0.447
|
SECONDARY outcome
Timeframe: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 4
|
0.81 percent change
Standard Error 3.92
|
14.72 percent change
Standard Error 5.61
|
16.32 percent change
Standard Error 6.77
|
7.99 percent change
Standard Error 10.60
|
9.53 percent change
Standard Error 9.47
|
15.32 percent change
Standard Error 7.40
|
10.72 percent change
Standard Error 15.27
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 74
|
-11.52 percent change
Standard Error 6.52
|
49.16 percent change
Standard Error 15.59
|
—
|
89.11 percent change
Standard Error 15.49
|
—
|
71.99 percent change
Standard Error 11.10
|
—
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 76
|
-5.50 percent change
Standard Error 6.48
|
45.95 percent change
Standard Error 18.18
|
—
|
100.22 percent change
Standard Error 18.29
|
—
|
78.57 percent change
Standard Error 13.74
|
—
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 169
|
7.58 percent change
Standard Error 7.52
|
4.79 percent change
Standard Error 7.31
|
-16.91 percent change
Standard Error 7.34
|
1.42 percent change
Standard Error 6.81
|
11.67 percent change
Standard Error 11.51
|
5.78 percent change
Standard Error 9.42
|
-7.07 percent change
Standard Error 10.52
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 2
|
-4.55 percent change
Standard Error 3.83
|
5.90 percent change
Standard Error 4.97
|
4.37 percent change
Standard Error 3.98
|
1.18 percent change
Standard Error 4.35
|
-0.71 percent change
Standard Error 3.94
|
8.46 percent change
Standard Error 6.50
|
-0.64 percent change
Standard Error 13.43
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 6
|
-5.99 percent change
Standard Error 4.33
|
46.69 percent change
Standard Error 7.59
|
32.85 percent change
Standard Error 7.41
|
23.19 percent change
Standard Error 10.40
|
32.18 percent change
Standard Error 4.75
|
27.78 percent change
Standard Error 7.72
|
33.83 percent change
Standard Error 19.09
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 8
|
-1.65 percent change
Standard Error 5.47
|
45.25 percent change
Standard Error 8.02
|
37.14 percent change
Standard Error 11.60
|
42.17 percent change
Standard Error 3.90
|
69.31 percent change
Standard Error 5.50
|
47.44 percent change
Standard Error 12.82
|
70.63 percent change
Standard Error 24.65
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 15
|
-0.87 percent change
Standard Error 6.06
|
58.03 percent change
Standard Error 11.52
|
66.12 percent change
Standard Error 14.63
|
76.66 percent change
Standard Error 21.28
|
103.66 percent change
Standard Error 7.37
|
58.81 percent change
Standard Error 12.45
|
123.92 percent change
Standard Error 39.13
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 22
|
0.20 percent change
Standard Error 5.41
|
82.97 percent change
Standard Error 21.49
|
53.76 percent change
Standard Error 19.99
|
107.88 percent change
Standard Error 19.52
|
117.63 percent change
Standard Error 9.76
|
96.08 percent change
Standard Error 13.47
|
142.64 percent change
Standard Error 34.70
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 29
|
-0.36 percent change
Standard Error 5.54
|
81.45 percent change
Standard Error 20.35
|
26.35 percent change
Standard Error 10.41
|
118.17 percent change
Standard Error 17.03
|
74.50 percent change
Standard Error 16.33
|
88.21 percent change
Standard Error 11.96
|
115.09 percent change
Standard Error 26.83
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 36
|
5.42 percent change
Standard Error 5.56
|
78.03 percent change
Standard Error 21.98
|
59.50 percent change
Standard Error 21.56
|
140.47 percent change
Standard Error 17.70
|
103.87 percent change
Standard Error 22.54
|
105.96 percent change
Standard Error 14.87
|
147.40 percent change
Standard Error 32.52
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 43
|
2.97 percent change
Standard Error 5.73
|
69.94 percent change
Standard Error 20.47
|
62.16 percent change
Standard Error 23.95
|
93.15 percent change
Standard Error 20.34
|
129.43 percent change
Standard Error 21.06
|
98.49 percent change
Standard Error 17.18
|
139.62 percent change
Standard Error 31.52
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 50
|
-12.20 percent change
Standard Error 5.65
|
73.72 percent change
Standard Error 23.57
|
—
|
128.64 percent change
Standard Error 16.55
|
—
|
86.45 percent change
Standard Error 14.88
|
—
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 57
|
1.74 percent change
Standard Error 5.20
|
51.66 percent change
Standard Error 20.71
|
3.28 percent change
Standard Error 10.72
|
95.15 percent change
Standard Error 21.45
|
77.00 percent change
Standard Error 20.31
|
76.98 percent change
Standard Error 12.12
|
74.16 percent change
Standard Error 19.64
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 58
|
12.47 percent change
Standard Error 6.76
|
—
|
-7.77 percent change
Standard Error 9.58
|
—
|
54.04 percent change
Standard Error 16.51
|
—
|
82.95 percent change
Standard Error 20.45
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 60
|
3.74 percent change
Standard Error 5.80
|
—
|
0.47 percent change
Standard Error 5.66
|
—
|
61.32 percent change
Standard Error 17.08
|
—
|
85.82 percent change
Standard Error 19.44
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 62
|
5.62 percent change
Standard Error 2.62
|
—
|
11.85 percent change
Standard Error 9.79
|
—
|
64.38 percent change
Standard Error 8.62
|
—
|
94.88 percent change
Standard Error 12.29
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 64
|
12.70 percent change
Standard Error 12.29
|
49.88 percent change
Standard Error 14.11
|
10.92 percent change
Standard Error 11.34
|
65.34 percent change
Standard Error 19.45
|
89.15 percent change
Standard Error 12.34
|
68.67 percent change
Standard Error 11.96
|
113.79 percent change
Standard Error 18.18
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 71
|
0.11 percent change
Standard Error 2.87
|
51.25 percent change
Standard Error 15.27
|
20.01 percent change
Standard Error 13.17
|
88.47 percent change
Standard Error 15.08
|
64.99 percent change
Standard Error 21.83
|
60.58 percent change
Standard Error 14.65
|
113.62 percent change
Standard Error 19.09
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 72
|
-2.97 percent change
Standard Error 4.13
|
32.99 percent change
Standard Error 14.43
|
—
|
71.55 percent change
Standard Error 7.88
|
—
|
63.76 percent change
Standard Error 15.42
|
—
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 78
|
2.61 percent change
Standard Error 5.24
|
51.59 percent change
Standard Error 18.64
|
1.29 percent change
Standard Error 11.31
|
77.58 percent change
Standard Error 19.98
|
49.94 percent change
Standard Error 17.55
|
75.17 percent change
Standard Error 23.08
|
65.32 percent change
Standard Error 13.57
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 85
|
-2.40 percent change
Standard Error 3.78
|
35.64 percent change
Standard Error 11.54
|
-3.90 percent change
Standard Error 10.10
|
79.77 percent change
Standard Error 20.53
|
24.94 percent change
Standard Error 9.30
|
54.06 percent change
Standard Error 11.05
|
44.44 percent change
Standard Error 22.42
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 99
|
-1.01 percent change
Standard Error 4.04
|
3.21 percent change
Standard Error 8.94
|
-16.47 percent change
Standard Error 8.68
|
31.38 percent change
Standard Error 18.42
|
-5.07 percent change
Standard Error 13.01
|
14.97 percent change
Standard Error 8.53
|
12.17 percent change
Standard Error 16.53
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 113
|
3.39 percent change
Standard Error 5.36
|
5.15 percent change
Standard Error 8.34
|
-14.06 percent change
Standard Error 8.68
|
-4.43 percent change
Standard Error 9.13
|
-9.38 percent change
Standard Error 12.06
|
-0.83 percent change
Standard Error 9.20
|
-7.13 percent change
Standard Error 11.60
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 127
|
5.21 percent change
Standard Error 6.81
|
-3.26 percent change
Standard Error 6.94
|
-8.76 percent change
Standard Error 9.73
|
-9.51 percent change
Standard Error 10.10
|
-0.76 percent change
Standard Error 17.80
|
-7.63 percent change
Standard Error 7.01
|
-5.88 percent change
Standard Error 9.47
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 141
|
4.35 percent change
Standard Error 4.72
|
-5.75 percent change
Standard Error 5.62
|
-19.84 percent change
Standard Error 7.87
|
2.88 percent change
Standard Error 10.84
|
22.42 percent change
Standard Error 16.17
|
-12.85 percent change
Standard Error 12.79
|
-9.24 percent change
Standard Error 8.87
|
|
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 155
|
5.71 percent change
Standard Error 4.91
|
-5.45 percent change
Standard Error 6.57
|
-19.92 percent change
Standard Error 9.17
|
-0.73 percent change
Standard Error 8.70
|
5.49 percent change
Standard Error 22.07
|
1.76 percent change
Standard Error 10.00
|
-6.88 percent change
Standard Error 9.24
|
SECONDARY outcome
Timeframe: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Osteocalcin
Day 2
|
-0.19 percent change
Standard Error 2.81
|
6.61 percent change
Standard Error 2.18
|
-7.02 percent change
Standard Error 4.56
|
4.95 percent change
Standard Error 4.34
|
-4.09 percent change
Standard Error 6.71
|
9.53 percent change
Standard Error 3.94
|
-4.69 percent change
Standard Error 5.12
|
|
Percent Change From Baseline in Osteocalcin
Day 8
|
-3.68 percent change
Standard Error 3.16
|
-7.13 percent change
Standard Error 3.83
|
-4.14 percent change
Standard Error 6.29
|
22.82 percent change
Standard Error 5.24
|
41.85 percent change
Standard Error 29.46
|
17.92 percent change
Standard Error 8.35
|
-2.77 percent change
Standard Error 4.06
|
|
Percent Change From Baseline in Osteocalcin
Day 15
|
-0.15 percent change
Standard Error 2.34
|
23.55 percent change
Standard Error 10.75
|
21.18 percent change
Standard Error 6.94
|
33.18 percent change
Standard Error 9.05
|
70.19 percent change
Standard Error 15.1
|
45.22 percent change
Standard Error 13.53
|
24.73 percent change
Standard Error 5.35
|
|
Percent Change From Baseline in Osteocalcin
Day 78
|
-3.86 percent change
Standard Error 3.35
|
29.10 percent change
Standard Error 8.42
|
12.60 percent change
Standard Error 11.10
|
74.99 percent change
Standard Error 13.37
|
85.53 percent change
Standard Error 15.09
|
56.10 percent change
Standard Error 19.30
|
89.23 percent change
Standard Error 23.86
|
|
Percent Change From Baseline in Osteocalcin
Day 4
|
-3.07 percent change
Standard Error 2.54
|
1.17 percent change
Standard Error 6.38
|
-13.51 percent change
Standard Error 1.88
|
-21.97 percent change
Standard Error 5.50
|
6.66 percent change
Standard Error 6.63
|
9.13 percent change
Standard Error 17.95
|
-9.27 percent change
Standard Error 2.61
|
|
Percent Change From Baseline in Osteocalcin
Day 6
|
-4.74 percent change
Standard Error 2.91
|
-5.55 percent change
Standard Error 6.37
|
-14.09 percent change
Standard Error 5.65
|
-0.71 percent change
Standard Error 6.79
|
11.34 percent change
Standard Error 6.43
|
16.14 percent change
Standard Error 13.24
|
-2.00 percent change
Standard Error 3.09
|
|
Percent Change From Baseline in Osteocalcin
Day 22
|
-4.19 percent change
Standard Error 2.06
|
29.99 percent change
Standard Error 8.26
|
34.90 percent change
Standard Error 16.55
|
57.55 percent change
Standard Error 11.24
|
84.14 percent change
Standard Error 12.09
|
61.18 percent change
Standard Error 19.45
|
64.18 percent change
Standard Error 10.17
|
|
Percent Change From Baseline in Osteocalcin
Day 29
|
0.02 percent change
Standard Error 2.67
|
49.44 percent change
Standard Error 16.03
|
39.52 percent change
Standard Error 11.33
|
81.71 percent change
Standard Error 19.20
|
90.08 percent change
Standard Error 7.79
|
55.58 percent change
Standard Error 10.40
|
79.45 percent change
Standard Error 17.12
|
|
Percent Change From Baseline in Osteocalcin
Day 36
|
3.54 percent change
Standard Error 2.61
|
48.91 percent change
Standard Error 10.93
|
35.29 percent change
Standard Error 9.36
|
76.70 percent change
Standard Error 12.51
|
87.21 percent change
Standard Error 16.45
|
35.55 percent change
Standard Error 12.53
|
68.03 percent change
Standard Error 8.81
|
|
Percent Change From Baseline in Osteocalcin
Day 43
|
1.20 percent change
Standard Error 2.85
|
45.46 percent change
Standard Error 12.44
|
30.75 percent change
Standard Error 14.39
|
77.15 percent change
Standard Error 14.86
|
90.14 percent change
Standard Error 17.06
|
57.62 percent change
Standard Error 13.39
|
82.02 percent change
Standard Error 14.92
|
|
Percent Change From Baseline in Osteocalcin
Day 50
|
0.92 percent change
Standard Error 5.00
|
48.63 percent change
Standard Error 13.20
|
—
|
89.23 percent change
Standard Error 18.31
|
—
|
52.53 percent change
Standard Error 19.49
|
—
|
|
Percent Change From Baseline in Osteocalcin
Day 57
|
4.07 percent change
Standard Error 2.05
|
49.28 percent change
Standard Error 10.45
|
-0.80 percent change
Standard Error 15.19
|
70.82 percent change
Standard Error 16.48
|
74.73 percent change
Standard Error 8.81
|
69.16 percent change
Standard Error 19.15
|
81.16 percent change
Standard Error 16.26
|
|
Percent Change From Baseline in Osteocalcin
Day 58
|
7.56 percent change
Standard Error 5.24
|
—
|
8.12 percent change
Standard Error 11.58
|
—
|
75.01 percent change
Standard Error 14.15
|
—
|
75.70 percent change
Standard Error 20.03
|
|
Percent Change From Baseline in Osteocalcin
Day 60
|
0.77 percent change
Standard Error 5.59
|
—
|
3.28 percent change
Standard Error 11.15
|
—
|
61.68 percent change
Standard Error 9.37
|
—
|
57.90 percent change
Standard Error 19.58
|
|
Percent Change From Baseline in Osteocalcin
Day 62
|
14.12 percent change
Standard Error 3.88
|
—
|
2.04 percent change
Standard Error 9.84
|
—
|
67.70 percent change
Standard Error 12.26
|
—
|
47.72 percent change
Standard Error 17.80
|
|
Percent Change From Baseline in Osteocalcin
Day 64
|
6.99 percent change
Standard Error 4.49
|
27.01 percent change
Standard Error 9.96
|
0.57 percent change
Standard Error 10.33
|
60.91 percent change
Standard Error 11.91
|
70.63 percent change
Standard Error 10.99
|
50.40 percent change
Standard Error 22.63
|
68.64 percent change
Standard Error 16.90
|
|
Percent Change From Baseline in Osteocalcin
Day 71
|
1.87 percent change
Standard Error 3.02
|
39.49 percent change
Standard Error 12.97
|
27.96 percent change
Standard Error 11.89
|
81.01 percent change
Standard Error 20.69
|
77.51 percent change
Standard Error 7.93
|
51.69 percent change
Standard Error 16.41
|
79.70 percent change
Standard Error 19.98
|
|
Percent Change From Baseline in Osteocalcin
Day 72
|
5.04 percent change
Standard Error 5.29
|
32.17 percent change
Standard Error 9.97
|
—
|
95.28 percent change
Standard Error 20.14
|
—
|
63.00 percent change
Standard Error 13.12
|
—
|
|
Percent Change From Baseline in Osteocalcin
Day 74
|
-5.91 percent change
Standard Error 2.36
|
31.72 percent change
Standard Error 10.55
|
—
|
60.58 percent change
Standard Error 13.97
|
—
|
52.83 percent change
Standard Error 12.14
|
—
|
|
Percent Change From Baseline in Osteocalcin
Day 76
|
-4.13 percent change
Standard Error 7.92
|
36.41 percent change
Standard Error 9.63
|
—
|
49.94 percent change
Standard Error 3.93
|
—
|
60.11 percent change
Standard Error 16.94
|
—
|
|
Percent Change From Baseline in Osteocalcin
Day 85
|
-4.37 percent change
Standard Error 3.11
|
41.36 percent change
Standard Error 11.92
|
19.11 percent change
Standard Error 9.44
|
63.71 percent change
Standard Error 11.99
|
77.23 percent change
Standard Error 16.82
|
48.66 percent change
Standard Error 12.49
|
81.93 percent change
Standard Error 31.34
|
|
Percent Change From Baseline in Osteocalcin
Day 99
|
-4.97 percent change
Standard Error 3.94
|
21.81 percent change
Standard Error 7.95
|
-9.45 percent change
Standard Error 6.47
|
49.49 percent change
Standard Error 16.14
|
31.98 percent change
Standard Error 6.31
|
33.70 percent change
Standard Error 18.41
|
30.28 percent change
Standard Error 26.45
|
|
Percent Change From Baseline in Osteocalcin
Day 113
|
2.57 percent change
Standard Error 4.85
|
4.81 percent change
Standard Error 8.41
|
-11.70 percent change
Standard Error 6.94
|
31.46 percent change
Standard Error 10.14
|
20.24 percent change
Standard Error 15.41
|
12.25 percent change
Standard Error 12.11
|
6.17 percent change
Standard Error 10.83
|
|
Percent Change From Baseline in Osteocalcin
Day 127
|
-0.34 percent change
Standard Error 4.46
|
2.79 percent change
Standard Error 13.64
|
-13.58 percent change
Standard Error 4.48
|
24.45 percent change
Standard Error 15.36
|
152.92 percent change
Standard Error 144.30
|
5.06 percent change
Standard Error 14.88
|
-3.88 percent change
Standard Error 11.30
|
|
Percent Change From Baseline in Osteocalcin
Day 141
|
-3.80 percent change
Standard Error 3.25
|
-2.99 percent change
Standard Error 8.22
|
-25.33 percent change
Standard Error 10.05
|
21.63 percent change
Standard Error 8.86
|
17.25 percent change
Standard Error 9.58
|
8.58 percent change
Standard Error 9.20
|
-4.33 percent change
Standard Error 7.28
|
|
Percent Change From Baseline in Osteocalcin
Day 155
|
-3.51 percent change
Standard Error 4.78
|
-6.23 percent change
Standard Error 7.52
|
-21.04 percent change
Standard Error 7.35
|
7.69 percent change
Standard Error 8.01
|
6.85 percent change
Standard Error 14.51
|
-7.10 percent change
Standard Error 10.56
|
-11.15 percent change
Standard Error 14.79
|
|
Percent Change From Baseline in Osteocalcin
Day 169
|
1.25 percent change
Standard Error 5.30
|
-7.12 percent change
Standard Error 7.84
|
-20.27 percent change
Standard Error 8.66
|
16.81 percent change
Standard Error 12.43
|
24.60 percent change
Standard Error 12.75
|
2.19 percent change
Standard Error 10.84
|
-13.66 percent change
Standard Error 10.56
|
SECONDARY outcome
Timeframe: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 2
|
-0.07 percent change
Standard Error 2.80
|
-4.51 percent change
Standard Error 3.09
|
-8.52 percent change
Standard Error 3.73
|
10.25 percent change
Standard Error 3.50
|
2.22 percent change
Standard Error 4.04
|
5.82 percent change
Standard Error 2.73
|
-0.80 percent change
Standard Error 4.20
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 50
|
-5.81 percent change
Standard Error 4.23
|
45.38 percent change
Standard Error 15.81
|
—
|
68.67 percent change
Standard Error 11.00
|
—
|
34.97 percent change
Standard Error 10.37
|
—
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 72
|
-7.83 percent change
Standard Error 3.96
|
32.18 percent change
Standard Error 12.27
|
—
|
50.19 percent change
Standard Error 10.57
|
—
|
19.60 percent change
Standard Error 10.46
|
—
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 74
|
-11.97 percent change
Standard Error 7.31
|
20.46 percent change
Standard Error 15.03
|
—
|
57.85 percent change
Standard Error 10.91
|
—
|
15.07 percent change
Standard Error 13.92
|
—
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 4
|
2.16 percent change
Standard Error 3.11
|
-2.74 percent change
Standard Error 4.96
|
-4.52 percent change
Standard Error 7.52
|
13.74 percent change
Standard Error 3.39
|
1.15 percent change
Standard Error 6.14
|
8.29 percent change
Standard Error 6.28
|
6.68 percent change
Standard Error 3.66
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 6
|
2.26 percent change
Standard Error 3.85
|
11.82 percent change
Standard Error 7.95
|
7.76 percent change
Standard Error 3.93
|
14.17 percent change
Standard Error 2.52
|
12.59 percent change
Standard Error 4.56
|
3.64 percent change
Standard Error 6.40
|
6.93 percent change
Standard Error 1.29
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 8
|
-3.30 percent change
Standard Error 5.72
|
20.02 percent change
Standard Error 10.24
|
9.69 percent change
Standard Error 4.75
|
21.51 percent change
Standard Error 6.34
|
21.87 percent change
Standard Error 9.57
|
24.20 percent change
Standard Error 14.92
|
20.98 percent change
Standard Error 2.05
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 15
|
-3.26 percent change
Standard Error 3.45
|
31.67 percent change
Standard Error 14.36
|
31.96 percent change
Standard Error 6.28
|
33.68 percent change
Standard Error 8.61
|
51.97 percent change
Standard Error 5.28
|
15.58 percent change
Standard Error 4.69
|
46.38 percent change
Standard Error 8.63
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 22
|
1.23 percent change
Standard Error 3.14
|
39.83 percent change
Standard Error 11.04
|
37.30 percent change
Standard Error 4.15
|
58.45 percent change
Standard Error 14.40
|
57.66 percent change
Standard Error 9.91
|
27.74 percent change
Standard Error 7.34
|
61.39 percent change
Standard Error 14.64
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 29
|
-2.04 percent change
Standard Error 2.94
|
56.09 percent change
Standard Error 19.29
|
36.50 percent change
Standard Error 8.85
|
65.10 percent change
Standard Error 14.72
|
61.66 percent change
Standard Error 13.21
|
36.74 percent change
Standard Error 10.53
|
35.63 percent change
Standard Error 13.78
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 36
|
0.04 percent change
Standard Error 3.62
|
54.87 percent change
Standard Error 14.40
|
28.89 percent change
Standard Error 7.65
|
72.39 percent change
Standard Error 12.18
|
63.55 percent change
Standard Error 10.27
|
43.48 percent change
Standard Error 7.98
|
34.27 percent change
Standard Error 7.92
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 43
|
-1.93 percent change
Standard Error 5.02
|
49.26 percent change
Standard Error 14.03
|
39.33 percent change
Standard Error 10.46
|
68.54 percent change
Standard Error 12.84
|
66.74 percent change
Standard Error 10.38
|
27.55 percent change
Standard Error 8.68
|
52.27 percent change
Standard Error 13.48
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 57
|
-2.15 percent change
Standard Error 5.99
|
41.39 percent change
Standard Error 11.28
|
38.07 percent change
Standard Error 11.16
|
65.28 percent change
Standard Error 9.34
|
47.38 percent change
Standard Error 6.06
|
38.47 percent change
Standard Error 12.18
|
44.53 percent change
Standard Error 11.57
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 58
|
-2.79 percent change
Standard Error 8.79
|
—
|
29.12 percent change
Standard Error 12.18
|
—
|
39.33 percent change
Standard Error 5.29
|
—
|
44.24 percent change
Standard Error 13.63
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 60
|
-7.26 percent change
Standard Error 5.69
|
—
|
18.64 percent change
Standard Error 9.41
|
—
|
38.07 percent change
Standard Error 7.47
|
—
|
36.75 percent change
Standard Error 11.16
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 62
|
-8.41 percent change
Standard Error 5.03
|
—
|
24.58 percent change
Standard Error 10.61
|
—
|
38.52 percent change
Standard Error 7.59
|
—
|
31.71 percent change
Standard Error 10.53
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 64
|
-8.42 percent change
Standard Error 5.15
|
34.60 percent change
Standard Error 12.41
|
19.54 percent change
Standard Error 5.71
|
77.50 percent change
Standard Error 10.29
|
38.38 percent change
Standard Error 7.43
|
27.78 percent change
Standard Error 13.26
|
45.24 percent change
Standard Error 9.78
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 71
|
-8.14 percent change
Standard Error 4.26
|
34.29 percent change
Standard Error 11.32
|
16.29 percent change
Standard Error 6.39
|
52.77 percent change
Standard Error 7.72
|
44.72 percent change
Standard Error 9.30
|
25.46 percent change
Standard Error 15.12
|
47.47 percent change
Standard Error 9.99
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 76
|
-9.30 percent change
Standard Error 5.16
|
40.67 percent change
Standard Error 12.44
|
—
|
51.82 percent change
Standard Error 9.53
|
—
|
17.91 percent change
Standard Error 12.86
|
—
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 78
|
-3.54 percent change
Standard Error 4.26
|
33.07 percent change
Standard Error 12.20
|
19.74 percent change
Standard Error 6.38
|
64.46 percent change
Standard Error 11.16
|
43.30 percent change
Standard Error 14.16
|
13.37 percent change
Standard Error 7.30
|
47.07 percent change
Standard Error 12.38
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 85
|
-1.70 percent change
Standard Error 3.61
|
26.01 percent change
Standard Error 12.18
|
7.70 percent change
Standard Error 5.59
|
69.90 percent change
Standard Error 21.35
|
38.27 percent change
Standard Error 4.20
|
18.68 percent change
Standard Error 9.63
|
42.53 percent change
Standard Error 14.53
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 99
|
-3.35 percent change
Standard Error 4.67
|
23.36 percent change
Standard Error 10.68
|
-1.91 percent change
Standard Error 3.22
|
24.89 percent change
Standard Error 14.52
|
5.10 percent change
Standard Error 1.62
|
17.55 percent change
Standard Error 17.51
|
13.75 percent change
Standard Error 6.54
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 113
|
7.31 percent change
Standard Error 6.57
|
10.26 percent change
Standard Error 9.51
|
-3.15 percent change
Standard Error 3.85
|
14.75 percent change
Standard Error 5.08
|
-5.26 percent change
Standard Error 10.20
|
-6.58 percent change
Standard Error 3.92
|
14.50 percent change
Standard Error 5.38
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 127
|
0.52 percent change
Standard Error 5.26
|
-2.73 percent change
Standard Error 7.12
|
-2.30 percent change
Standard Error 4.12
|
9.62 percent change
Standard Error 6.27
|
1.13 percent change
Standard Error 6.36
|
-6.54 percent change
Standard Error 7.54
|
5.26 percent change
Standard Error 5.75
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 141
|
2.55 percent change
Standard Error 5.44
|
-1.68 percent change
Standard Error 6.67
|
-5.98 percent change
Standard Error 5.03
|
2.90 percent change
Standard Error 7.10
|
3.75 percent change
Standard Error 3.96
|
-4.71 percent change
Standard Error 4.43
|
9.34 percent change
Standard Error 3.25
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 155
|
5.25 percent change
Standard Error 5.28
|
-0.82 percent change
Standard Error 6.82
|
-4.10 percent change
Standard Error 4.67
|
6.15 percent change
Standard Error 4.92
|
5.12 percent change
Standard Error 6.77
|
-4.11 percent change
Standard Error 3.38
|
6.78 percent change
Standard Error 8.32
|
|
Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Day 169
|
3.90 percent change
Standard Error 5.22
|
-1.37 percent change
Standard Error 6.27
|
-5.72 percent change
Standard Error 5.75
|
2.33 percent change
Standard Error 4.19
|
16.26 percent change
Standard Error 7.56
|
-4.76 percent change
Standard Error 5.36
|
-0.42 percent change
Standard Error 6.39
|
SECONDARY outcome
Timeframe: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 2
|
-7.31 percent change
Standard Error 4.30
|
12.29 percent change
Standard Error 9.15
|
-11.32 percent change
Standard Error 4.22
|
8.05 percent change
Standard Error 9.96
|
-7.07 percent change
Standard Error 7.36
|
-10.15 percent change
Standard Error 10.74
|
-6.57 percent change
Standard Error 3.50
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 4
|
-5.51 percent change
Standard Error 5.87
|
1.10 percent change
Standard Error 12.49
|
-19.03 percent change
Standard Error 9.12
|
-26.84 percent change
Standard Error 4.63
|
-25.85 percent change
Standard Error 7.05
|
-22.01 percent change
Standard Error 3.66
|
-34.13 percent change
Standard Error 3.28
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 29
|
-10.94 percent change
Standard Error 6.87
|
0.31 percent change
Standard Error 6.08
|
-21.11 percent change
Standard Error 8.86
|
-25.43 percent change
Standard Error 6.08
|
-21.54 percent change
Standard Error 10.95
|
-32.76 percent change
Standard Error 4.85
|
-34.53 percent change
Standard Error 8.14
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 43
|
-14.14 percent change
Standard Error 7.40
|
3.91 percent change
Standard Error 9.40
|
-13.79 percent change
Standard Error 15.06
|
-34.04 percent change
Standard Error 3.35
|
-20.49 percent change
Standard Error 12.73
|
-28.54 percent change
Standard Error 6.07
|
-44.64 percent change
Standard Error 7.31
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 141
|
-21.10 percent change
Standard Error 6.53
|
4.86 percent change
Standard Error 10.74
|
-12.11 percent change
Standard Error 14.71
|
1.99 percent change
Standard Error 9.89
|
13.34 percent change
Standard Error 14.80
|
-22.48 percent change
Standard Error 5.32
|
-21.35 percent change
Standard Error 9.69
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 155
|
-21.03 percent change
Standard Error 5.72
|
-0.02 percent change
Standard Error 8.21
|
-3.37 percent change
Standard Error 12.01
|
7.94 percent change
Standard Error 6.33
|
1.27 percent change
Standard Error 14.71
|
-14.43 percent change
Standard Error 12.92
|
-15.00 percent change
Standard Error 14.96
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 6
|
-12.60 percent change
Standard Error 5.74
|
-8.29 percent change
Standard Error 12.56
|
-26.11 percent change
Standard Error 10.32
|
-28.04 percent change
Standard Error 7.70
|
-36.98 percent change
Standard Error 5.38
|
-28.83 percent change
Standard Error 6.44
|
-35.78 percent change
Standard Error 3.37
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 8
|
-17.79 percent change
Standard Error 5.06
|
-14.65 percent change
Standard Error 11.02
|
-31.59 percent change
Standard Error 10.22
|
-28.92 percent change
Standard Error 3.05
|
-35.93 percent change
Standard Error 3.90
|
-42.09 percent change
Standard Error 4.09
|
-43.93 percent change
Standard Error 3.44
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 15
|
-18.86 percent change
Standard Error 5.92
|
-14.39 percent change
Standard Error 9.41
|
-35.11 percent change
Standard Error 8.69
|
-35.27 percent change
Standard Error 4.30
|
-33.00 percent change
Standard Error 7.65
|
-39.34 percent change
Standard Error 2.85
|
-48.74 percent change
Standard Error 5.56
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 22
|
-12.98 percent change
Standard Error 6.18
|
-4.88 percent change
Standard Error 9.99
|
-29.97 percent change
Standard Error 12.42
|
-37.34 percent change
Standard Error 3.50
|
-22.85 percent change
Standard Error 7.88
|
-36.63 percent change
Standard Error 6.67
|
-39.21 percent change
Standard Error 4.70
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 36
|
-20.96 percent change
Standard Error 7.87
|
4.50 percent change
Standard Error 11.96
|
-21.42 percent change
Standard Error 12.02
|
-38.33 percent change
Standard Error 2.21
|
-29.20 percent change
Standard Error 15.71
|
-36.51 percent change
Standard Error 9.31
|
-50.32 percent change
Standard Error 4.78
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 50
|
-12.62 percent change
Standard Error 7.98
|
-4.78 percent change
Standard Error 11.11
|
—
|
-26.11 percent change
Standard Error 5.90
|
—
|
-22.42 percent change
Standard Error 15.96
|
—
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 57
|
-17.59 percent change
Standard Error 6.11
|
14.35 percent change
Standard Error 10.32
|
-4.53 percent change
Standard Error 17.99
|
-23.74 percent change
Standard Error 6.45
|
-13.47 percent change
Standard Error 15.73
|
-25.25 percent change
Standard Error 12.27
|
-31.52 percent change
Standard Error 7.89
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 58
|
-20.27 percent change
Standard Error 7.58
|
—
|
-9.15 percent change
Standard Error 9.82
|
—
|
-9.63 percent change
Standard Error 15.05
|
—
|
-28.19 percent change
Standard Error 8.64
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 60
|
-14.95 percent change
Standard Error 10.06
|
—
|
-8.80 percent change
Standard Error 13.64
|
—
|
-22.34 percent change
Standard Error 16.06
|
—
|
-28.04 percent change
Standard Error 11.68
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 62
|
-14.01 percent change
Standard Error 10.87
|
—
|
-25.09 percent change
Standard Error 10.87
|
—
|
-21.83 percent change
Standard Error 18.62
|
—
|
-41.37 percent change
Standard Error 8.69
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 64
|
-10.22 percent change
Standard Error 7.59
|
6.59 percent change
Standard Error 16.03
|
-20.16 percent change
Standard Error 8.81
|
-20.09 percent change
Standard Error 4.55
|
-18.72 percent change
Standard Error 14.04
|
-20.03 percent change
Standard Error 12.81
|
-34.86 percent change
Standard Error 10.25
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 71
|
-15.23 percent change
Standard Error 5.58
|
26.63 percent change
Standard Error 14.92
|
-14.42 percent change
Standard Error 11.82
|
-18.24 percent change
Standard Error 7.26
|
-14.03 percent change
Standard Error 13.60
|
-11.02 percent change
Standard Error 18.12
|
-38.38 percent change
Standard Error 4.37
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 72
|
-19.21 percent change
Standard Error 6.72
|
11.70 percent change
Standard Error 13.66
|
—
|
-17.32 percent change
Standard Error 7.84
|
—
|
-8.98 percent change
Standard Error 16.64
|
—
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 74
|
-6.15 percent change
Standard Error 8.32
|
7.40 percent change
Standard Error 11.86
|
—
|
-16.32 percent change
Standard Error 6.94
|
—
|
-9.80 percent change
Standard Error 14.64
|
—
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 76
|
-19.35 percent change
Standard Error 5.70
|
11.70 percent change
Standard Error 9.88
|
—
|
-17.14 percent change
Standard Error 9.24
|
—
|
-17.12 percent change
Standard Error 13.70
|
—
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 78
|
-18.50 percent change
Standard Error 6.03
|
9.18 percent change
Standard Error 11.45
|
-14.82 percent change
Standard Error 10.85
|
-17.99 percent change
Standard Error 10.44
|
11.88 percent change
Standard Error 21.63
|
-5.24 percent change
Standard Error 18.22
|
-21.66 percent change
Standard Error 11.50
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 85
|
-12.69 percent change
Standard Error 5.84
|
14.95 percent change
Standard Error 13.45
|
8.97 percent change
Standard Error 10.90
|
-13.06 percent change
Standard Error 9.08
|
13.77 percent change
Standard Error 22.18
|
-16.89 percent change
Standard Error 16.84
|
-17.17 percent change
Standard Error 10.09
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 99
|
-20.31 percent change
Standard Error 5.21
|
7.45 percent change
Standard Error 8.41
|
-15.79 percent change
Standard Error 9.03
|
-7.79 percent change
Standard Error 8.64
|
-5.14 percent change
Standard Error 17.67
|
-13.22 percent change
Standard Error 17.06
|
-8.18 percent change
Standard Error 10.80
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 113
|
-15.61 percent change
Standard Error 6.74
|
4.66 percent change
Standard Error 11.35
|
-18.77 percent change
Standard Error 12.28
|
0.18 percent change
Standard Error 13.58
|
-7.88 percent change
Standard Error 13.06
|
-10.06 percent change
Standard Error 10.22
|
-8.20 percent change
Standard Error 12.19
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 127
|
-19.03 percent change
Standard Error 5.79
|
-5.63 percent change
Standard Error 13.21
|
-12.96 percent change
Standard Error 12.78
|
0.46 percent change
Standard Error 10.01
|
-4.92 percent change
Standard Error 18.73
|
1.68 percent change
Standard Error 14.91
|
-16.92 percent change
Standard Error 13.00
|
|
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Day 169
|
-16.59 percent change
Standard Error 6.74
|
-1.13 percent change
Standard Error 8.37
|
-9.38 percent change
Standard Error 12.56
|
-0.92 percent change
Standard Error 15.29
|
-0.27 percent change
Standard Error 10.41
|
-15.61 percent change
Standard Error 11.74
|
-10.10 percent change
Standard Error 9.54
|
SECONDARY outcome
Timeframe: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 2
|
-5.72 percent change
Standard Error 4.12
|
-13.34 percent change
Standard Error 6.82
|
-2.09 percent change
Standard Error 12.69
|
7.94 percent change
Standard Error 4.48
|
-1.06 percent change
Standard Error 5.09
|
8.68 percent change
Standard Error 5.69
|
-5.04 percent change
Standard Error 8.62
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 4
|
-18.14 percent change
Standard Error 2.42
|
0.35 percent change
Standard Error 13.61
|
18.59 percent change
Standard Error 17.92
|
2.94 percent change
Standard Error 19.63
|
1.34 percent change
Standard Error 10.38
|
-5.59 percent change
Standard Error 31.57
|
-3.14 percent change
Standard Error 14.09
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 43
|
-14.84 percent change
Standard Error 5.36
|
28.17 percent change
Standard Error 11.49
|
47.38 percent change
Standard Error 19.72
|
23.77 percent change
Standard Error 26.38
|
73.55 percent change
Standard Error 22.75
|
39.90 percent change
Standard Error 17.90
|
37.55 percent change
Standard Error 31.09
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 50
|
-7.02 percent change
Standard Error 9.81
|
30.25 percent change
Standard Error 19.47
|
—
|
34.06 percent change
Standard Error 31.75
|
—
|
41.77 percent change
Standard Error 27.38
|
—
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 57
|
-13.17 percent change
Standard Error 6.57
|
66.13 percent change
Standard Error 35.48
|
31.59 percent change
Standard Error 25.03
|
26.12 percent change
Standard Error 20.92
|
26.23 percent change
Standard Error 13.73
|
26.14 percent change
Standard Error 26.62
|
23.55 percent change
Standard Error 28.82
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 6
|
-22.64 percent change
Standard Error 5.59
|
-2.67 percent change
Standard Error 8.79
|
23.15 percent change
Standard Error 15.52
|
8.42 percent change
Standard Error 17.70
|
43.89 percent change
Standard Error 18.45
|
20.35 percent change
Standard Error 21.69
|
-4.22 percent change
Standard Error 11.74
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 8
|
-22.84 percent change
Standard Error 5.19
|
-0.20 percent change
Standard Error 6.59
|
16.68 percent change
Standard Error 13.79
|
-7.82 percent change
Standard Error 8.93
|
12.58 percent change
Standard Error 13.18
|
-2.24 percent change
Standard Error 9.43
|
9.33 percent change
Standard Error 24.92
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 15
|
-8.84 percent change
Standard Error 5.93
|
7.31 percent change
Standard Error 12.26
|
18.72 percent change
Standard Error 12.98
|
-10.00 percent change
Standard Error 7.92
|
67.27 percent change
Standard Error 35.74
|
-1.40 percent change
Standard Error 14.42
|
12.46 percent change
Standard Error 27.05
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 22
|
-9.12 percent change
Standard Error 4.45
|
63.58 percent change
Standard Error 41.80
|
28.93 percent change
Standard Error 15.69
|
0.65 percent change
Standard Error 17.49
|
69.17 percent change
Standard Error 22.48
|
24.27 percent change
Standard Error 21.16
|
48.13 percent change
Standard Error 37.16
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 29
|
-7.45 percent change
Standard Error 6.70
|
26.13 percent change
Standard Error 14.71
|
41.90 percent change
Standard Error 10.87
|
34.10 percent change
Standard Error 25.51
|
41.45 percent change
Standard Error 17.60
|
23.91 percent change
Standard Error 21.12
|
3.68 percent change
Standard Error 19.02
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 36
|
-14.24 percent change
Standard Error 4.63
|
25.21 percent change
Standard Error 11.90
|
57.32 percent change
Standard Error 15.99
|
22.33 percent change
Standard Error 25.29
|
54.47 percent change
Standard Error 18.24
|
37.99 percent change
Standard Error 26.79
|
10.94 percent change
Standard Error 14.70
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 58
|
-10.21 percent change
Standard Error 7.73
|
—
|
34.80 percent change
Standard Error 16.82
|
—
|
57.65 percent change
Standard Error 25.32
|
—
|
24.71 percent change
Standard Error 15.33
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 60
|
-8.41 percent change
Standard Error 9.17
|
—
|
52.00 percent change
Standard Error 20.18
|
—
|
72.18 percent change
Standard Error 16.59
|
—
|
56.06 percent change
Standard Error 31.40
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 62
|
-2.33 percent change
Standard Error 10.30
|
—
|
48.83 percent change
Standard Error 20.01
|
—
|
47.94 percent change
Standard Error 18.36
|
—
|
37.93 percent change
Standard Error 22.34
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 64
|
-6.40 percent change
Standard Error 8.29
|
19.81 percent change
Standard Error 11.29
|
62.54 percent change
Standard Error 17.33
|
30.11 percent change
Standard Error 13.35
|
62.07 percent change
Standard Error 18.54
|
49.59 percent change
Standard Error 26.25
|
64.46 percent change
Standard Error 31.92
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 71
|
-10.38 percent change
Standard Error 3.86
|
21.65 percent change
Standard Error 17.69
|
40.97 percent change
Standard Error 15.06
|
7.80 percent change
Standard Error 17.50
|
68.44 percent change
Standard Error 26.27
|
11.07 percent change
Standard Error 24.13
|
15.84 percent change
Standard Error 12.81
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 72
|
-19.26 percent change
Standard Error 8.34
|
32.07 percent change
Standard Error 19.22
|
—
|
41.99 percent change
Standard Error 35.57
|
—
|
30.65 percent change
Standard Error 17.43
|
—
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 74
|
-9.74 percent change
Standard Error 6.73
|
32.25 percent change
Standard Error 25.26
|
—
|
21.37 percent change
Standard Error 17.25
|
—
|
71.86 percent change
Standard Error 39.62
|
—
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 76
|
-8.27 percent change
Standard Error 6.56
|
32.24 percent change
Standard Error 14.18
|
—
|
2.58 percent change
Standard Error 14.33
|
—
|
20.58 percent change
Standard Error 20.98
|
—
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 78
|
-16.60 percent change
Standard Error 5.70
|
21.00 percent change
Standard Error 14.55
|
44.03 percent change
Standard Error 11.32
|
31.00 percent change
Standard Error 22.68
|
56.98 percent change
Standard Error 25.29
|
28.62 percent change
Standard Error 13.12
|
22.73 percent change
Standard Error 27.28
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 85
|
-3.49 percent change
Standard Error 5.98
|
16.48 percent change
Standard Error 11.90
|
47.95 percent change
Standard Error 9.94
|
-3.99 percent change
Standard Error 13.52
|
24.90 percent change
Standard Error 19.86
|
33.55 percent change
Standard Error 22.61
|
29.25 percent change
Standard Error 25.49
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 99
|
-20.78 percent change
Standard Error 5.77
|
20.49 percent change
Standard Error 13.44
|
14.08 percent change
Standard Error 7.81
|
5.91 percent change
Standard Error 26.94
|
12.34 percent change
Standard Error 11.46
|
3.12 percent change
Standard Error 12.69
|
2.69 percent change
Standard Error 19.10
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 113
|
-7.05 percent change
Standard Error 7.87
|
0.16 percent change
Standard Error 12.53
|
13.91 percent change
Standard Error 11.95
|
-5.87 percent change
Standard Error 11.21
|
-10.83 percent change
Standard Error 19.52
|
13.19 percent change
Standard Error 18.27
|
16.73 percent change
Standard Error 18.23
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 127
|
-12.50 percent change
Standard Error 5.08
|
-16.74 percent change
Standard Error 7.08
|
3.14 percent change
Standard Error 14.76
|
-11.32 percent change
Standard Error 7.81
|
-7.07 percent change
Standard Error 6.79
|
-2.02 percent change
Standard Error 17.24
|
6.96 percent change
Standard Error 13.62
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 141
|
-16.41 percent change
Standard Error 3.26
|
-5.85 percent change
Standard Error 9.79
|
-8.33 percent change
Standard Error 8.30
|
-19.91 percent change
Standard Error 6.71
|
-4.19 percent change
Standard Error 6.92
|
-16.85 percent change
Standard Error 13.53
|
10.80 percent change
Standard Error 18.12
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 155
|
-15.06 percent change
Standard Error 4.78
|
1.27 percent change
Standard Error 8.24
|
10.09 percent change
Standard Error 11.69
|
-15.78 percent change
Standard Error 7.72
|
17.62 percent change
Standard Error 9.94
|
-3.50 percent change
Standard Error 10.45
|
8.76 percent change
Standard Error 16.71
|
|
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 169
|
-9.95 percent change
Standard Error 7.25
|
-18.84 percent change
Standard Error 7.75
|
-10.08 percent change
Standard Error 13.08
|
-19.71 percent change
Standard Error 9.00
|
30.72 percent change
Standard Error 20.07
|
-3.01 percent change
Standard Error 10.49
|
15.09 percent change
Standard Error 21.69
|
SECONDARY outcome
Timeframe: Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169Population: Treated participants with available data at baseline and each time point
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Sclerostin
Day 43
|
4.4 percent change
Standard Error 8.5
|
4669.2 percent change
Standard Error 1119.6
|
6229.6 percent change
Standard Error 475.2
|
9023.8 percent change
Standard Error 1003.7
|
8471.0 percent change
Standard Error 506.6
|
4613.9 percent change
Standard Error 486.2
|
6486.0 percent change
Standard Error 621.2
|
|
Percent Change From Baseline in Sclerostin
Day 71
|
-1.9 percent change
Standard Error 5.7
|
4949.6 percent change
Standard Error 1133.1
|
6905.1 percent change
Standard Error 875.7
|
10130.3 percent change
Standard Error 1041.3
|
9114.5 percent change
Standard Error 812.4
|
5405.1 percent change
Standard Error 667.6
|
7735.8 percent change
Standard Error 949.8
|
|
Percent Change From Baseline in Sclerostin
Day 85
|
-2.2 percent change
Standard Error 5.8
|
4886.5 percent change
Standard Error 1085.4
|
3004.2 percent change
Standard Error 538.5
|
10566.4 percent change
Standard Error 1667.4
|
5403.5 percent change
Standard Error 1285.7
|
5254.5 percent change
Standard Error 588.9
|
4873.7 percent change
Standard Error 520.7
|
|
Percent Change From Baseline in Sclerostin
Day 15
|
-5.6 percent change
Standard Error 4.7
|
3135.6 percent change
Standard Error 665.6
|
5630.4 percent change
Standard Error 478.9
|
6087.5 percent change
Standard Error 651.1
|
7532.4 percent change
Standard Error 627.8
|
2809.3 percent change
Standard Error 241.8
|
6816.0 percent change
Standard Error 775.1
|
|
Percent Change From Baseline in Sclerostin
Day 29
|
-3.6 percent change
Standard Error 5.4
|
4068.2 percent change
Standard Error 923.8
|
2335.8 percent change
Standard Error 283.2
|
7713.1 percent change
Standard Error 997.9
|
4993.3 percent change
Standard Error 890.2
|
3904.4 percent change
Standard Error 399.2
|
4573.0 percent change
Standard Error 614.4
|
|
Percent Change From Baseline in Sclerostin
Day 57
|
0.4 percent change
Standard Error 7.2
|
5143.9 percent change
Standard Error 1145.2
|
3024.9 percent change
Standard Error 290.7
|
8450.2 percent change
Standard Error 545.0
|
6137.5 percent change
Standard Error 1319.7
|
4450.8 percent change
Standard Error 471.5
|
4739.5 percent change
Standard Error 660.2
|
|
Percent Change From Baseline in Sclerostin
Day 99
|
-3.5 percent change
Standard Error 6.9
|
2496.0 percent change
Standard Error 806.8
|
952.8 percent change
Standard Error 362.7
|
6748.3 percent change
Standard Error 1165.3
|
2124.2 percent change
Standard Error 736.4
|
1960.4 percent change
Standard Error 461.1
|
2183.7 percent change
Standard Error 520.7
|
|
Percent Change From Baseline in Sclerostin
Day 113
|
-7.3 percent change
Standard Error 6.5
|
883.2 percent change
Standard Error 397.5
|
399.4 percent change
Standard Error 175.9
|
3556.2 percent change
Standard Error 627.9
|
473.3 percent change
Standard Error 129.2
|
395.4 percent change
Standard Error 57.0
|
804.9 percent change
Standard Error 257.7
|
|
Percent Change From Baseline in Sclerostin
Day 127
|
0.2 percent change
Standard Error 5.8
|
364.9 percent change
Standard Error 185.9
|
161.5 percent change
Standard Error 67.9
|
1410.2 percent change
Standard Error 273.0
|
202.6 percent change
Standard Error 58.2
|
242.5 percent change
Standard Error 150.0
|
311.3 percent change
Standard Error 117.9
|
|
Percent Change From Baseline in Sclerostin
Day 141
|
2.1 percent change
Standard Error 7.5
|
203.9 percent change
Standard Error 110.6
|
84.6 percent change
Standard Error 47.3
|
524.3 percent change
Standard Error 109.9
|
178.2 percent change
Standard Error 101.5
|
74.2 percent change
Standard Error 25.5
|
128.2 percent change
Standard Error 61.5
|
|
Percent Change From Baseline in Sclerostin
Day 155
|
2.6 percent change
Standard Error 9.0
|
118.8 percent change
Standard Error 78.9
|
57.4 percent change
Standard Error 35.5
|
298.6 percent change
Standard Error 67.4
|
41.0 percent change
Standard Error 21.8
|
88.6 percent change
Standard Error 43.3
|
48.3 percent change
Standard Error 36.6
|
|
Percent Change From Baseline in Sclerostin
Day 169
|
1.9 percent change
Standard Error 9.1
|
76.1 percent change
Standard Error 37.7
|
40.3 percent change
Standard Error 27.8
|
177.3 percent change
Standard Error 37.8
|
845.3 percent change
Standard Error 528.9
|
713.7 percent change
Standard Error 688.9
|
16.8 percent change
Standard Error 20.9
|
SECONDARY outcome
Timeframe: Baseline and day 169 (or earlier for participants who discontinued before day 169)Population: Treated participants
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 Participants
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 Participants
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 Participants
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ionized Calcium
|
0.05 mg/dL
Standard Deviation 0.17
|
0.12 mg/dL
Standard Deviation 0.10
|
0.06 mg/dL
Standard Deviation 0.21
|
-0.07 mg/dL
Standard Deviation 0.18
|
-0.05 mg/dL
Standard Deviation 0.04
|
-0.14 mg/dL
Standard Deviation 0.18
|
-0.06 mg/dL
Standard Deviation 0.14
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Romosozumab 1 mg/kg Q2W in Women
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Romosozumab 2 mg/kg Q4W in Women
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Romosozumab 2 mg/kg Q2W in Women
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Romosozumab 3 mg/kg Q4W in Women
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Romosozumab 1 mg/kg Q2W in Men
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Romosozumab 3 mg/kg Q4W in Men
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 participants at risk
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 participants at risk
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 participants at risk
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 participants at risk
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 participants at risk
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 participants at risk
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
|
Romosozumab 1 mg/kg Q2W in Women
n=6 participants at risk
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 2 mg/kg Q4W in Women
n=6 participants at risk
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 2 mg/kg Q2W in Women
n=6 participants at risk
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Women
n=6 participants at risk
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
Romosozumab 1 mg/kg Q2W in Men
n=6 participants at risk
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
|
Romosozumab 3 mg/kg Q4W in Men
n=6 participants at risk
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
VISION BLURRED
|
25.0%
3/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
GINGIVAL ULCERATION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
LIP ULCERATION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
ASTHENIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FATIGUE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FEELING COLD
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE DISCOMFORT
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE INDURATION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE IRRITATION
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
SENSATION OF FOREIGN BODY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
VENIPUNCTURE SITE SWELLING
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
INFECTED INSECT BITE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
VULVITIS
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
HEART RATE INCREASED
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
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)
SKIN PAPILLOMA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
DIZZINESS
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
DYSGEUSIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEADACHE
|
33.3%
4/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
SOMNOLENCE
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
ANXIETY
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
VULVOVAGINAL BURNING SENSATION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
8.3%
1/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.7%
2/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/12 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • 169 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • 169 days
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