Trial Outcomes & Findings for A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women (NCT NCT01059435)
NCT ID: NCT01059435
Last Updated: 2019-07-05
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
74 participants
Primary outcome timeframe
Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Results posted on
2019-07-05
Participant Flow
This was a single-center study conducted in the USA. The first participant enrolled on 13 December 2006 and the last participant completed the study on 06 July 2007.
Participants were enrolled sequentially into 1 of 6 dose cohorts. Healthy postmenopausal women were randomized to romosozumab or placebo in a 3:1 ratio at 0.1, 0.3, 1 mg/kg SC, 1 mg/kg IV, 3, 5 mg/kg SC, 10 mg/kg SC, or 10 mg/kg IV; healthy men received romosozumab SC or IV, placebo SC or IV in a 3:3:1:1 ratio at doses of 1 mg/kg or 10 mg/kg.
Participant milestones
| Measure |
Placebo SC
Participants received a single subcutaneous (SC) injection of matching placebo.
|
Romosozumab 0.1 mg/kg SC
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
8
|
9
|
6
|
9
|
6
|
4
|
6
|
6
|
|
Overall Study
Received Study Drug
|
14
|
6
|
6
|
9
|
6
|
9
|
6
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
6
|
9
|
6
|
9
|
6
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
SC Dosing
|
52.79 years
STANDARD_DEVIATION 4.17 • n=99 Participants
|
53.00 years
STANDARD_DEVIATION 3.95 • n=107 Participants
|
53.33 years
STANDARD_DEVIATION 3.20 • n=206 Participants
|
52.00 years
STANDARD_DEVIATION 4.64 • n=7 Participants
|
55.00 years
STANDARD_DEVIATION 4.05 • n=31 Participants
|
51.89 years
STANDARD_DEVIATION 2.32 • n=30 Participants
|
52.50 years
STANDARD_DEVIATION 4.32 • n=3 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
NA years
STANDARD_DEVIATION NA • n=114 Participants
|
NA years
STANDARD_DEVIATION NA
|
52.80 years
STANDARD_DEVIATION 3.79 • n=19 Participants
|
|
Age, Continuous
IV Dosing
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
52.50 years
STANDARD_DEVIATION 4.43 • n=6 Participants
|
49.33 years
STANDARD_DEVIATION 4.63 • n=114 Participants
|
51.00 years
STANDARD_DEVIATION 3.35
|
50.75 years
STANDARD_DEVIATION 4.06 • n=19 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
3 Participants
|
56 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
3 Participants
|
16 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
6 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
6 Participants
|
65 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.Population: 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 |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Serious treatment-related adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Discontinuations due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any adverse event
|
4 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).Population: All treated participants
Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-romosozumab Antibodies
Binding antibody positive
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants Who Developed Anti-romosozumab Antibodies
Neutralizing antibody positive
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received subcutaneous romosozumab
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Romosozumab
|
1280 ng/mL
Standard Deviation 653
|
4890 ng/mL
Standard Deviation 1780
|
21300 ng/mL
Standard Deviation 5170
|
33500 ng/mL
Standard Deviation 8290
|
75200 ng/mL
Standard Deviation 15900
|
—
|
—
|
—
|
—
|
375 ng/mL
Standard Deviation 182
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received subcutaneous romosozumab
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Romosozumab
|
2.5 days
Interval 2.0 to 5.0
|
3 days
Interval 2.0 to 14.0
|
5 days
Interval 4.0 to 7.0
|
5 days
Interval 3.0 to 7.0
|
4.5 days
Interval 2.0 to 7.0
|
—
|
—
|
—
|
—
|
1.5 days
Interval 0.5 to 7.0
|
SECONDARY outcome
Timeframe: Day 1 at the end of infusionPopulation: All treated participants who received intravenously administered romosozumab
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Initial Concentration Following IV Administration (C0) of Romosozumab
|
132000 ng/mL
Standard Deviation 13700
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24900 ng/mL
Standard Deviation 4670
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received romosozumab
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=6 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab
|
288 µg*hr/mL
Standard Deviation 144
|
1480 µg*hr/mL
Standard Deviation 605
|
8170 µg*hr/mL
Standard Deviation 1810
|
16900 µg*hr/mL
Standard Deviation 4350
|
43400 µg*hr/mL
Standard Deviation 8550
|
3020 µg*hr/mL
Standard Deviation 989
|
24400 µg*hr/mL
Standard Deviation 4400
|
—
|
—
|
78.5 µg*hr/mL
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received romosozumab
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=6 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab
|
1.35 mL/hr/kg
Standard Deviation 0.841
|
0.873 mL/hr/kg
Standard Deviation 0.647
|
0.383 mL/hr/kg
Standard Deviation 0.0901
|
0.319 mL/hr/kg
Standard Deviation 0.0998
|
0.236 mL/hr/kg
Standard Deviation 0.0370
|
0.362 mL/hr/kg
Standard Deviation 0.117
|
0.210 mL/hr/kg
Standard Deviation 0.0361
|
—
|
—
|
1.39 mL/hr/kg
Standard Deviation 0.489
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received 3, 5, or 10 mg/kg romosozumab
The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=6 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab
|
—
|
—
|
11.1 days
Standard Deviation 3.70
|
12.9 days
Standard Deviation 3.14
|
18.0 days
Standard Deviation 3.54
|
—
|
10.6 days
Standard Deviation 1.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants who received romosozumab
The terminal (gamma, γ) phase half-life (t½,γ) was calculated from the natural log of 2 divided by the terminal rate constant (λz).
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=6 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=6 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab
|
5.13 days
Standard Deviation 0.640
|
5.50 days
Standard Deviation 0.322
|
6.68 days
Standard Deviation 0.961
|
5.81 days
Standard Deviation 0.874
|
5.88 days
Standard Deviation 1.60
|
4.49 days
Standard Deviation 0.974
|
4.93 days
Standard Deviation 0.639
|
—
|
—
|
5.20 days
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)
|
57.7 ng/mL
Standard Deviation 22.8
|
60.9 ng/mL
Standard Deviation 14.4
|
60.7 ng/mL
Standard Deviation 10.8
|
100.8 ng/mL
Standard Deviation 49.6
|
125.1 ng/mL
Standard Deviation 44.2
|
141.4 ng/mL
Standard Deviation 24.8
|
77.0 ng/mL
Standard Deviation 35.3
|
76.3 ng/mL
Standard Deviation 19.8
|
173.4 ng/mL
Standard Deviation 43.3
|
69.8 ng/mL
Standard Deviation 32.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the time to maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Effect of P1NP
|
11.0 days
Interval 6.0 to 29.0
|
4.5 days
Interval 1.0 to 15.0
|
15.0 days
Interval 11.0 to 57.0
|
22.0 days
Interval 15.0 to 22.0
|
22.0 days
Interval 15.0 to 29.0
|
25.5 days
Interval 22.0 to 36.0
|
43.0 days
Interval 1.0 to 57.0
|
15.0 days
Interval 11.0 to 22.0
|
18.5 days
Interval 15.0 to 29.0
|
39.5 days
Interval 1.0 to 64.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP
|
1431 days*ng/mL
Standard Deviation 548
|
1564 days*ng/mL
Standard Deviation 377
|
1473 days*ng/mL
Standard Deviation 304
|
2300 days*ng/mL
Standard Deviation 1099
|
2780 days*ng/mL
Standard Deviation 1007
|
2986 days*ng/mL
Standard Deviation 306
|
1714 days*ng/mL
Standard Deviation 782
|
1794 days*ng/mL
Standard Deviation 434
|
3940 days*ng/mL
Standard Deviation 944
|
1529 days*ng/mL
Standard Deviation 633
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP
|
1431 days*ng/mL
Standard Deviation 548
|
1564 days*ng/mL
Standard Deviation 377
|
2782 days*ng/mL
Standard Deviation 513
|
3962 days*ng/mL
Standard Deviation 1702
|
6759 days*ng/mL
Standard Deviation 2434
|
7846 days*ng/mL
Standard Deviation 1264
|
4487 days*ng/mL
Standard Deviation 2352
|
3138 days*ng/mL
Standard Deviation 723
|
8976 days*ng/mL
Standard Deviation 2531
|
3234 days*ng/mL
Standard Deviation 1462
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the minimum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Effect for Serum C-telopeptide (sCTX)
|
0.4 ng/mL
Standard Deviation 0.2
|
0.3 ng/mL
Standard Deviation 0.1
|
0.3 ng/mL
Standard Deviation 0.1
|
0.4 ng/mL
Standard Deviation 0.1
|
0.2 ng/mL
Standard Deviation 0.1
|
0.2 ng/mL
Standard Deviation 0.1
|
0.3 ng/mL
Standard Deviation 0.2
|
0.2 ng/mL
Standard Deviation 0.1
|
0.2 ng/mL
Standard Deviation 0.1
|
0.3 ng/mL
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the time to minimum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Effect of sCTX
|
1.0 days
Interval 1.0 to 1.0
|
1.0 days
Interval 1.0 to 1.0
|
1.0 days
Interval 1.0 to 43.0
|
1.0 days
Interval 1.0 to 50.0
|
8.0 days
Interval 1.0 to 78.0
|
6.0 days
Interval 1.0 to 22.0
|
18.5 days
Interval 1.0 to 43.0
|
1.0 days
Interval 1.0 to 1.0
|
1.0 days
Interval 1.0 to 64.0
|
1.0 days
Interval 1.0 to 36.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX
|
21 days*ng/mL
Standard Deviation 6
|
18 days*ng/mL
Standard Deviation 5
|
15 days*ng/mL
Standard Deviation 6
|
14 days*ng/mL
Standard Deviation 3
|
11 days*ng/mL
Standard Deviation 4
|
8 days*ng/mL
Standard Deviation 3
|
21 days*ng/mL
Standard Deviation 8
|
13 days*ng/mL
Standard Deviation 3
|
12 days*ng/mL
Standard Deviation 5
|
20 days*ng/mL
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX
|
21 days*ng/mL
Standard Deviation 6
|
18 days*ng/mL
Standard Deviation 5
|
30 days*ng/mL
Standard Deviation 13
|
29 days*ng/mL
Standard Deviation 7
|
41 days*ng/mL
Standard Deviation 18
|
40 days*ng/mL
Standard Deviation 15
|
44 days*ng/mL
Standard Deviation 20
|
26 days*ng/mL
Standard Deviation 6
|
44 days*ng/mL
Standard Deviation 13
|
37 days*ng/mL
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Effect for Osteocalcin
|
25.6 µg/L
Standard Deviation 8.0
|
25.8 µg/L
Standard Deviation 4.8
|
26.6 µg/L
Standard Deviation 5.5
|
36.9 µg/L
Standard Deviation 10.9
|
39.0 µg/L
Standard Deviation 12.7
|
53.9 µg/L
Standard Deviation 10.5
|
35.9 µg/L
Standard Deviation 13.9
|
28.8 µg/L
Standard Deviation 7.7
|
53.5 µg/L
Standard Deviation 12.8
|
28.9 µg/L
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the time to maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Effect of Osteocalcin
|
15.0 days
Interval 2.0 to 15.0
|
18.5 days
Interval 2.0 to 38.0
|
22.0 days
Interval 11.0 to 36.0
|
22.0 days
Interval 22.0 to 29.0
|
29.0 days
Interval 29.0 to 50.0
|
36.0 days
Interval 26.0 to 57.0
|
34.0 days
Interval 5.0 to 64.0
|
22.0 days
Interval 11.0 to 36.0
|
32.5 days
Interval 29.0 to 43.0
|
29.0 days
Interval 2.0 to 57.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin
|
611 days*µg/L
Standard Deviation 191
|
658 days*µg/L
Standard Deviation 153
|
570 days*µg/L
Standard Deviation 139
|
753 days*µg/L
Standard Deviation 234
|
757 days*µg/L
Standard Deviation 225
|
881 days*µg/L
Standard Deviation 162
|
759 days*µg/L
Standard Deviation 286
|
559 days*µg/L
Standard Deviation 73
|
973 days*µg/L
Standard Deviation 212
|
617 days*µg/L
Standard Deviation 209
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin
|
611 days*µg/L
Standard Deviation 191
|
658 days*µg/L
Standard Deviation 153
|
1129 days*µg/L
Standard Deviation 256
|
1487 days*µg/L
Standard Deviation 453
|
2470 days*µg/L
Standard Deviation 827
|
2964 days*µg/L
Standard Deviation 563
|
1897 days*µg/L
Standard Deviation 519
|
1132 days*µg/L
Standard Deviation 131
|
2988 days*µg/L
Standard Deviation 460
|
1259 days*µg/L
Standard Deviation 505
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)
|
18.0 µg/L
Standard Deviation 6.7
|
17.2 µg/L
Standard Deviation 3.2
|
17.7 µg/L
Standard Deviation 4.7
|
26.1 µg/L
Standard Deviation 7.8
|
24.6 µg/L
Standard Deviation 8.6
|
29.9 µg/L
Standard Deviation 8.2
|
19.6 µg/L
Standard Deviation 3.7
|
15.9 µg/L
Standard Deviation 4.5
|
36.4 µg/L
Standard Deviation 15.9
|
21.0 µg/L
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the time to maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Effect of BSAP
|
16.5 days
Interval 4.0 to 29.0
|
13.0 days
Interval 6.0 to 19.0
|
15.0 days
Interval 8.0 to 29.0
|
22.0 days
Interval 22.0 to 22.0
|
22.0 days
Interval 22.0 to 36.0
|
22.0 days
Interval 15.0 to 29.0
|
46.5 days
Interval 6.0 to 85.0
|
13.5 days
Interval 6.0 to 50.0
|
29.0 days
Interval 22.0 to 36.0
|
36.0 days
Interval 4.0 to 78.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP
|
460 days*µg/L
Standard Deviation 172
|
460 days*µg/L
Standard Deviation 127
|
422 days*µg/L
Standard Deviation 100
|
588 days*µg/L
Standard Deviation 152
|
540 days*µg/L
Standard Deviation 210
|
639 days*µg/L
Standard Deviation 176
|
448 days*µg/L
Standard Deviation 73
|
376 days*µg/L
Standard Deviation 102
|
780 days*µg/L
Standard Deviation 325
|
462 days*µg/L
Standard Deviation 157
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP
|
460 days*µg/L
Standard Deviation 172
|
460 days*µg/L
Standard Deviation 127
|
815 days*µg/L
Standard Deviation 190
|
1120 days*µg/L
Standard Deviation 303
|
1496 days*µg/L
Standard Deviation 527
|
1860 days*µg/L
Standard Deviation 508
|
1138 days*µg/L
Standard Deviation 191
|
731 days*µg/L
Standard Deviation 177
|
2033 days*µg/L
Standard Deviation 780
|
958 days*µg/L
Standard Deviation 428
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Effect for Intact Parathyroid Hormone (iPTH)
|
38.7 ng/L
Standard Deviation 11.9
|
54.5 ng/L
Standard Deviation 13.1
|
49.9 ng/L
Standard Deviation 20.5
|
62.8 ng/L
Standard Deviation 10.9
|
66.0 ng/L
Standard Deviation 20.0
|
76.3 ng/L
Standard Deviation 15.7
|
64.8 ng/L
Standard Deviation 27.8
|
52.7 ng/L
Standard Deviation 20.1
|
59.7 ng/L
Standard Deviation 14.9
|
43.3 ng/L
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Defined as the time to maximum value postdose.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Effect of iPTH
|
11.0 days
Interval 1.0 to 15.0
|
25.5 days
Interval 15.0 to 29.0
|
22.0 days
Interval 3.0 to 43.0
|
22.0 days
Interval 1.0 to 29.0
|
22.0 days
Interval 8.0 to 50.0
|
15.0 days
Interval 1.0 to 50.0
|
25.5 days
Interval 1.0 to 71.0
|
11.0 days
Interval 1.0 to 57.0
|
18.5 days
Interval 8.0 to 43.0
|
11.0 days
Interval 1.0 to 71.0
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH
|
823 days*ng/L
Standard Deviation 202
|
1234 days*ng/L
Standard Deviation 341
|
1002 days*ng/L
Standard Deviation 405
|
1270 days*ng/L
Standard Deviation 198
|
1240 days*ng/L
Standard Deviation 342
|
1422 days*ng/L
Standard Deviation 411
|
1235 days*ng/L
Standard Deviation 488
|
1074 days*ng/L
Standard Deviation 406
|
1239 days*ng/L
Standard Deviation 267
|
817 days*ng/L
Standard Deviation 295
|
SECONDARY outcome
Timeframe: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.Population: All treated participants
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH
|
823 days*ng/L
Standard Deviation 202
|
1234 days*ng/L
Standard Deviation 341
|
1971 days*ng/L
Standard Deviation 850
|
2523 days*ng/L
Standard Deviation 406
|
3483 days*ng/L
Standard Deviation 1057
|
4195 days*ng/L
Standard Deviation 1144
|
3100 days*ng/L
Standard Deviation 1077
|
2072 days*ng/L
Standard Deviation 749
|
3515 days*ng/L
Standard Deviation 1127
|
1592 days*ng/L
Standard Deviation 689
|
SECONDARY outcome
Timeframe: Baseline and days 15, 29, 43, 57, 71, and 85Population: All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed on days 71 and 85.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Sclerostin
Day 15
|
465.5 percent change
Standard Deviation 49.9
|
835.1 percent change
Standard Deviation 130.4
|
2123.8 percent change
Standard Deviation 377.6
|
7965.9 percent change
Standard Deviation 792.9
|
12375.7 percent change
Standard Deviation 1375.4
|
17774.8 percent change
Standard Deviation 2444.0
|
6.7 percent change
Standard Deviation 11.4
|
3776.0 percent change
Standard Deviation 461.5
|
14230.0 percent change
Standard Deviation 2428.1
|
53.2 percent change
Standard Deviation 54.3
|
|
Percent Change From Baseline in Sclerostin
Day 29
|
129.0 percent change
Standard Deviation 33.3
|
183.0 percent change
Standard Deviation 19.6
|
717.4 percent change
Standard Deviation 92.4
|
5140.2 percent change
Standard Deviation 373.7
|
9763.2 percent change
Standard Deviation 1252.8
|
18870.9 percent change
Standard Deviation 2707.3
|
-4.3 percent change
Standard Deviation 8.7
|
816.7 percent change
Standard Deviation 222.3
|
11715.5 percent change
Standard Deviation 2177.0
|
-8.4 percent change
Standard Deviation 7.0
|
|
Percent Change From Baseline in Sclerostin
Day 71
|
—
|
—
|
—
|
—
|
610.4 percent change
Standard Deviation 151.6
|
2080.8 percent change
Standard Deviation 689.0
|
-5.5 percent change
Standard Deviation 5.4
|
—
|
426.9 percent change
Standard Deviation 119.6
|
86.9 percent change
Standard Deviation 88.3
|
|
Percent Change From Baseline in Sclerostin
Day 85
|
—
|
—
|
—
|
—
|
232.1 percent change
Standard Deviation 49.0
|
758.0 percent change
Standard Deviation 270.1
|
0.8 percent change
Standard Deviation 13.4
|
—
|
109.8 percent change
Standard Deviation 30.6
|
11.6 percent change
Standard Deviation 16.6
|
|
Percent Change From Baseline in Sclerostin
Day 43
|
—
|
—
|
223.2 percent change
Standard Deviation 18.1
|
1988.3 percent change
Standard Deviation 339.9
|
4968.7 percent change
Standard Deviation 714.7
|
13902.7 percent change
Standard Deviation 2381.9
|
4.9 percent change
Standard Deviation 8.7
|
196.1 percent change
Standard Deviation 48.7
|
4576.0 percent change
Standard Deviation 1086.7
|
-9.8 percent change
Standard Deviation 14.1
|
|
Percent Change From Baseline in Sclerostin
Day 57
|
—
|
—
|
83.4 percent change
Standard Deviation 14.5
|
810.2 percent change
Standard Deviation 169.9
|
2004.9 percent change
Standard Deviation 421.5
|
6469.6 percent change
Standard Deviation 1000.3
|
15.6 percent change
Standard Deviation 0.6
|
49.9 percent change
Standard Deviation 17.4
|
1430.0 percent change
Standard Deviation 538.0
|
-3.7 percent change
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85Population: All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Calcium Over Time
Day 1 Hour 8
|
9.47 mg/dL
Standard Deviation 0.29
|
9.33 mg/dL
Standard Deviation 0.23
|
9.29 mg/dL
Standard Deviation 0.18
|
9.28 mg/dL
Standard Deviation 0.12
|
9.42 mg/dL
Standard Deviation 0.28
|
9.27 mg/dL
Standard Deviation 0.33
|
9.38 mg/dL
Standard Deviation 0.21
|
9.35 mg/dL
Standard Deviation 0.10
|
9.22 mg/dL
Standard Deviation 0.12
|
9.38 mg/dL
Standard Deviation 0.22
|
|
Serum Calcium Over Time
Day 1 Hour 10
|
9.62 mg/dL
Standard Deviation 0.31
|
9.50 mg/dL
Standard Deviation 0.27
|
9.40 mg/dL
Standard Deviation 0.30
|
9.38 mg/dL
Standard Deviation 0.19
|
9.36 mg/dL
Standard Deviation 0.31
|
9.28 mg/dL
Standard Deviation 0.27
|
9.50 mg/dL
Standard Deviation 0.22
|
9.45 mg/dL
Standard Deviation 0.16
|
9.42 mg/dL
Standard Deviation 0.15
|
9.53 mg/dL
Standard Deviation 0.26
|
|
Serum Calcium Over Time
Day 1 Hour 12
|
9.55 mg/dL
Standard Deviation 0.27
|
9.57 mg/dL
Standard Deviation 0.31
|
9.49 mg/dL
Standard Deviation 0.31
|
9.37 mg/dL
Standard Deviation 0.34
|
9.52 mg/dL
Standard Deviation 0.26
|
9.27 mg/dL
Standard Deviation 0.34
|
9.40 mg/dL
Standard Deviation 0.24
|
9.47 mg/dL
Standard Deviation 0.19
|
9.45 mg/dL
Standard Deviation 0.19
|
9.53 mg/dL
Standard Deviation 0.28
|
|
Serum Calcium Over Time
Day 5
|
9.38 mg/dL
Standard Deviation 0.21
|
9.37 mg/dL
Standard Deviation 0.25
|
9.38 mg/dL
Standard Deviation 0.24
|
9.32 mg/dL
Standard Deviation 0.25
|
9.24 mg/dL
Standard Deviation 0.26
|
9.15 mg/dL
Standard Deviation 0.18
|
9.55 mg/dL
Standard Deviation 0.17
|
9.20 mg/dL
Standard Deviation 0.15
|
9.12 mg/dL
Standard Deviation 0.19
|
9.42 mg/dL
Standard Deviation 0.36
|
|
Serum Calcium Over Time
Day 6
|
9.45 mg/dL
Standard Deviation 0.29
|
9.45 mg/dL
Standard Deviation 0.26
|
9.51 mg/dL
Standard Deviation 0.20
|
9.35 mg/dL
Standard Deviation 0.10
|
9.36 mg/dL
Standard Deviation 0.26
|
9.18 mg/dL
Standard Deviation 0.15
|
9.35 mg/dL
Standard Deviation 0.24
|
9.32 mg/dL
Standard Deviation 0.19
|
9.23 mg/dL
Standard Deviation 0.12
|
9.56 mg/dL
Standard Deviation 0.26
|
|
Serum Calcium Over Time
Day 29
|
9.58 mg/dL
Standard Deviation 0.22
|
9.40 mg/dL
Standard Deviation 0.26
|
9.44 mg/dL
Standard Deviation 0.37
|
9.20 mg/dL
Standard Deviation 0.27
|
9.32 mg/dL
Standard Deviation 0.28
|
8.95 mg/dL
Standard Deviation 0.19
|
9.38 mg/dL
Standard Deviation 0.13
|
9.17 mg/dL
Standard Deviation 0.21
|
9.15 mg/dL
Standard Deviation 0.23
|
9.49 mg/dL
Standard Deviation 0.32
|
|
Serum Calcium Over Time
Day 1 Pre-dose
|
9.45 mg/dL
Standard Deviation 0.38
|
9.50 mg/dL
Standard Deviation 0.33
|
9.48 mg/dL
Standard Deviation 0.27
|
9.42 mg/dL
Standard Deviation 0.25
|
9.53 mg/dL
Standard Deviation 0.26
|
9.38 mg/dL
Standard Deviation 0.24
|
9.60 mg/dL
Standard Deviation 0.22
|
9.23 mg/dL
Standard Deviation 0.15
|
9.37 mg/dL
Standard Deviation 0.15
|
9.49 mg/dL
Standard Deviation 0.34
|
|
Serum Calcium Over Time
Day 1 Hour 4
|
9.62 mg/dL
Standard Deviation 0.19
|
9.45 mg/dL
Standard Deviation 0.26
|
9.38 mg/dL
Standard Deviation 0.16
|
9.38 mg/dL
Standard Deviation 0.15
|
9.59 mg/dL
Standard Deviation 0.27
|
9.35 mg/dL
Standard Deviation 0.40
|
9.45 mg/dL
Standard Deviation 0.21
|
9.43 mg/dL
Standard Deviation 0.22
|
9.40 mg/dL
Standard Deviation 0.17
|
9.46 mg/dL
Standard Deviation 0.30
|
|
Serum Calcium Over Time
Day 1 Hour 6
|
9.38 mg/dL
Standard Deviation 0.22
|
9.50 mg/dL
Standard Deviation 0.14
|
9.47 mg/dL
Standard Deviation 0.17
|
9.60 mg/dL
Standard Deviation 0.24
|
9.48 mg/dL
Standard Deviation 0.35
|
9.25 mg/dL
Standard Deviation 0.36
|
9.18 mg/dL
Standard Deviation 0.13
|
9.38 mg/dL
Standard Deviation 0.31
|
9.40 mg/dL
Standard Deviation 0.15
|
9.49 mg/dL
Standard Deviation 0.26
|
|
Serum Calcium Over Time
Day 2
|
9.55 mg/dL
Standard Deviation 0.21
|
9.23 mg/dL
Standard Deviation 0.28
|
9.39 mg/dL
Standard Deviation 0.21
|
9.37 mg/dL
Standard Deviation 0.33
|
9.46 mg/dL
Standard Deviation 0.29
|
9.23 mg/dL
Standard Deviation 0.29
|
8.55 mg/dL
Standard Deviation 1.77
|
9.05 mg/dL
Standard Deviation 0.41
|
9.28 mg/dL
Standard Deviation 0.15
|
9.46 mg/dL
Standard Deviation 0.34
|
|
Serum Calcium Over Time
Day 3
|
9.37 mg/dL
Standard Deviation 0.29
|
9.25 mg/dL
Standard Deviation 0.39
|
9.20 mg/dL
Standard Deviation 0.34
|
9.35 mg/dL
Standard Deviation 0.14
|
9.38 mg/dL
Standard Deviation 0.41
|
9.18 mg/dL
Standard Deviation 0.17
|
9.40 mg/dL
Standard Deviation 0.24
|
9.13 mg/dL
Standard Deviation 0.51
|
9.27 mg/dL
Standard Deviation 0.18
|
9.30 mg/dL
Standard Deviation 0.61
|
|
Serum Calcium Over Time
Day 4
|
9.38 mg/dL
Standard Deviation 0.27
|
9.37 mg/dL
Standard Deviation 0.27
|
9.18 mg/dL
Standard Deviation 0.64
|
9.27 mg/dL
Standard Deviation 0.12
|
9.40 mg/dL
Standard Deviation 0.30
|
9.13 mg/dL
Standard Deviation 0.22
|
9.23 mg/dL
Standard Deviation 0.50
|
8.88 mg/dL
Standard Deviation 0.84
|
9.18 mg/dL
Standard Deviation 0.13
|
9.49 mg/dL
Standard Deviation 0.25
|
|
Serum Calcium Over Time
Day 8
|
9.45 mg/dL
Standard Deviation 0.20
|
9.28 mg/dL
Standard Deviation 0.23
|
9.36 mg/dL
Standard Deviation 0.44
|
9.23 mg/dL
Standard Deviation 0.10
|
9.33 mg/dL
Standard Deviation 0.40
|
8.93 mg/dL
Standard Deviation 0.28
|
9.30 mg/dL
Standard Deviation 0.22
|
9.18 mg/dL
Standard Deviation 0.29
|
9.20 mg/dL
Standard Deviation 0.37
|
9.41 mg/dL
Standard Deviation 0.31
|
|
Serum Calcium Over Time
Day 11
|
9.38 mg/dL
Standard Deviation 0.33
|
9.07 mg/dL
Standard Deviation 0.24
|
9.39 mg/dL
Standard Deviation 0.25
|
9.30 mg/dL
Standard Deviation 0.39
|
9.19 mg/dL
Standard Deviation 0.36
|
8.70 mg/dL
Standard Deviation 0.75
|
9.30 mg/dL
Standard Deviation 0.22
|
9.13 mg/dL
Standard Deviation 0.29
|
9.18 mg/dL
Standard Deviation 0.26
|
9.32 mg/dL
Standard Deviation 0.29
|
|
Serum Calcium Over Time
Day 15
|
9.60 mg/dL
Standard Deviation 0.17
|
9.40 mg/dL
Standard Deviation 0.32
|
9.26 mg/dL
Standard Deviation 0.21
|
9.22 mg/dL
Standard Deviation 0.19
|
9.06 mg/dL
Standard Deviation 0.35
|
8.97 mg/dL
Standard Deviation 0.18
|
9.33 mg/dL
Standard Deviation 0.22
|
9.28 mg/dL
Standard Deviation 0.33
|
9.00 mg/dL
Standard Deviation 0.36
|
9.39 mg/dL
Standard Deviation 0.26
|
|
Serum Calcium Over Time
Day 22
|
9.53 mg/dL
Standard Deviation 0.45
|
9.18 mg/dL
Standard Deviation 0.35
|
9.33 mg/dL
Standard Deviation 0.32
|
9.22 mg/dL
Standard Deviation 0.17
|
9.14 mg/dL
Standard Deviation 0.47
|
8.90 mg/dL
Standard Deviation 0.23
|
9.48 mg/dL
Standard Deviation 0.13
|
9.18 mg/dL
Standard Deviation 0.22
|
9.08 mg/dL
Standard Deviation 0.15
|
9.35 mg/dL
Standard Deviation 0.33
|
|
Serum Calcium Over Time
Day 36
|
—
|
—
|
9.33 mg/dL
Standard Deviation 0.26
|
9.23 mg/dL
Standard Deviation 0.30
|
9.00 mg/dL
Standard Deviation 0.26
|
9.07 mg/dL
Standard Deviation 0.26
|
9.25 mg/dL
Standard Deviation 0.30
|
9.18 mg/dL
Standard Deviation 0.35
|
9.00 mg/dL
Standard Deviation 0.30
|
9.40 mg/dL
Standard Deviation 0.45
|
|
Serum Calcium Over Time
Day 43
|
—
|
—
|
9.32 mg/dL
Standard Deviation 0.21
|
9.37 mg/dL
Standard Deviation 0.31
|
9.23 mg/dL
Standard Deviation 0.36
|
8.90 mg/dL
Standard Deviation 0.26
|
9.28 mg/dL
Standard Deviation 0.33
|
9.25 mg/dL
Standard Deviation 0.25
|
9.15 mg/dL
Standard Deviation 0.33
|
9.33 mg/dL
Standard Deviation 0.39
|
|
Serum Calcium Over Time
Day 50
|
—
|
—
|
9.30 mg/dL
Standard Deviation 0.41
|
9.03 mg/dL
Standard Deviation 0.21
|
9.40 mg/dL
Standard Deviation 0.34
|
8.98 mg/dL
Standard Deviation 0.19
|
9.33 mg/dL
Standard Deviation 0.33
|
9.43 mg/dL
Standard Deviation 0.50
|
9.07 mg/dL
Standard Deviation 0.23
|
9.35 mg/dL
Standard Deviation 0.26
|
|
Serum Calcium Over Time
Day 57
|
—
|
—
|
9.47 mg/dL
Standard Deviation 0.36
|
9.35 mg/dL
Standard Deviation 0.29
|
9.18 mg/dL
Standard Deviation 0.49
|
9.28 mg/dL
Standard Deviation 0.17
|
9.33 mg/dL
Standard Deviation 0.29
|
9.25 mg/dL
Standard Deviation 0.27
|
9.02 mg/dL
Standard Deviation 0.21
|
9.46 mg/dL
Standard Deviation 0.30
|
|
Serum Calcium Over Time
Day 64
|
—
|
—
|
—
|
—
|
9.28 mg/dL
Standard Deviation 0.42
|
8.90 mg/dL
Standard Deviation 0.36
|
9.25 mg/dL
Standard Deviation 0.07
|
—
|
9.18 mg/dL
Standard Deviation 0.35
|
9.22 mg/dL
Standard Deviation 0.15
|
|
Serum Calcium Over Time
Day 71
|
—
|
—
|
—
|
—
|
9.47 mg/dL
Standard Deviation 0.47
|
9.05 mg/dL
Standard Deviation 0.36
|
9.20 mg/dL
Standard Deviation 0.14
|
—
|
9.20 mg/dL
Standard Deviation 0.14
|
9.36 mg/dL
Standard Deviation 0.18
|
|
Serum Calcium Over Time
Day 78
|
—
|
—
|
—
|
—
|
9.31 mg/dL
Standard Deviation 0.32
|
9.07 mg/dL
Standard Deviation 0.40
|
9.20 mg/dL
Standard Deviation 0.00
|
—
|
9.12 mg/dL
Standard Deviation 0.34
|
9.30 mg/dL
Standard Deviation 0.24
|
|
Serum Calcium Over Time
Day 85
|
—
|
—
|
—
|
—
|
9.47 mg/dL
Standard Deviation 0.35
|
8.82 mg/dL
Standard Deviation 0.31
|
9.10 mg/dL
Standard Deviation 0.28
|
—
|
9.05 mg/dL
Standard Deviation 0.26
|
9.12 mg/dL
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85Population: All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.
Outcome measures
| Measure |
Romosozumab 0.1 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 Participants
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 Participants
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Placebo IV
n=4 Participants
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 1.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 Participants
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
|
Placebo SC
n=14 Participants
Participants received a single subcutaneous (SC) injection of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ionized Calcium Over Time
Day 1 Hour 4
|
5.02 mg/dL
Standard Deviation 0.17
|
5.10 mg/dL
Standard Deviation 0.13
|
5.11 mg/dL
Standard Deviation 0.24
|
5.03 mg/dL
Standard Deviation 0.10
|
5.12 mg/dL
Standard Deviation 0.32
|
4.95 mg/dL
Standard Deviation 0.08
|
5.40 mg/dL
Standard Deviation 0.14
|
5.35 mg/dL
Standard Deviation 0.18
|
5.40 mg/dL
Standard Deviation 0.09
|
5.06 mg/dL
Standard Deviation 0.20
|
|
Ionized Calcium Over Time
Day 1 Hour 12
|
4.95 mg/dL
Standard Deviation 0.08
|
5.00 mg/dL
Standard Deviation 0.15
|
5.01 mg/dL
Standard Deviation 0.20
|
4.93 mg/dL
Standard Deviation 0.16
|
5.03 mg/dL
Standard Deviation 0.30
|
4.80 mg/dL
Standard Deviation 0.11
|
5.28 mg/dL
Standard Deviation 0.22
|
5.25 mg/dL
Standard Deviation 0.10
|
5.33 mg/dL
Standard Deviation 0.08
|
5.01 mg/dL
Standard Deviation 0.18
|
|
Ionized Calcium Over Time
Day 2
|
5.03 mg/dL
Standard Deviation 0.16
|
4.92 mg/dL
Standard Deviation 0.17
|
5.03 mg/dL
Standard Deviation 0.17
|
4.98 mg/dL
Standard Deviation 0.12
|
5.04 mg/dL
Standard Deviation 0.19
|
4.88 mg/dL
Standard Deviation 0.15
|
5.28 mg/dL
Standard Deviation 0.10
|
5.08 mg/dL
Standard Deviation 0.08
|
5.18 mg/dL
Standard Deviation 0.10
|
5.04 mg/dL
Standard Deviation 0.20
|
|
Ionized Calcium Over Time
Day 3
|
5.00 mg/dL
Standard Deviation 0.13
|
4.97 mg/dL
Standard Deviation 0.14
|
5.00 mg/dL
Standard Deviation 0.14
|
4.95 mg/dL
Standard Deviation 0.08
|
5.12 mg/dL
Standard Deviation 0.20
|
4.85 mg/dL
Standard Deviation 0.05
|
5.28 mg/dL
Standard Deviation 0.13
|
5.17 mg/dL
Standard Deviation 0.12
|
5.25 mg/dL
Standard Deviation 0.14
|
5.06 mg/dL
Standard Deviation 0.19
|
|
Ionized Calcium Over Time
Day 4
|
4.97 mg/dL
Standard Deviation 0.15
|
4.85 mg/dL
Standard Deviation 0.16
|
5.03 mg/dL
Standard Deviation 0.10
|
4.87 mg/dL
Standard Deviation 0.12
|
5.11 mg/dL
Standard Deviation 0.20
|
4.82 mg/dL
Standard Deviation 0.08
|
5.23 mg/dL
Standard Deviation 0.17
|
5.20 mg/dL
Standard Deviation 0.09
|
5.17 mg/dL
Standard Deviation 0.14
|
5.05 mg/dL
Standard Deviation 0.17
|
|
Ionized Calcium Over Time
Day 5
|
4.93 mg/dL
Standard Deviation 0.10
|
4.88 mg/dL
Standard Deviation 0.25
|
5.04 mg/dL
Standard Deviation 0.12
|
4.93 mg/dL
Standard Deviation 0.12
|
5.04 mg/dL
Standard Deviation 0.19
|
4.80 mg/dL
Standard Deviation 0.06
|
5.40 mg/dL
Standard Deviation 0.14
|
5.18 mg/dL
Standard Deviation 0.12
|
5.15 mg/dL
Standard Deviation 0.14
|
5.02 mg/dL
Standard Deviation 0.18
|
|
Ionized Calcium Over Time
Day 6
|
4.91 mg/dL
Standard Deviation 0.14
|
4.97 mg/dL
Standard Deviation 0.12
|
5.06 mg/dL
Standard Deviation 0.11
|
4.88 mg/dL
Standard Deviation 0.10
|
5.02 mg/dL
Standard Deviation 0.14
|
4.80 mg/dL
Standard Deviation 0.06
|
5.23 mg/dL
Standard Deviation 0.10
|
5.23 mg/dL
Standard Deviation 0.12
|
5.05 mg/dL
Standard Deviation 0.10
|
5.02 mg/dL
Standard Deviation 0.16
|
|
Ionized Calcium Over Time
Day 8
|
4.98 mg/dL
Standard Deviation 0.08
|
4.92 mg/dL
Standard Deviation 0.10
|
5.01 mg/dL
Standard Deviation 0.24
|
4.83 mg/dL
Standard Deviation 0.10
|
4.89 mg/dL
Standard Deviation 0.18
|
5.00 mg/dL
Standard Deviation 0.14
|
5.23 mg/dL
Standard Deviation 0.17
|
5.17 mg/dL
Standard Deviation 0.12
|
5.07 mg/dL
Standard Deviation 0.19
|
5.02 mg/dL
Standard Deviation 0.17
|
|
Ionized Calcium Over Time
Day 11
|
5.05 mg/dL
Standard Deviation 0.14
|
4.93 mg/dL
Standard Deviation 0.14
|
5.06 mg/dL
Standard Deviation 0.17
|
4.90 mg/dL
Standard Deviation 0.13
|
4.92 mg/dL
Standard Deviation 0.15
|
5.00 mg/dL
Standard Deviation 0.11
|
5.23 mg/dL
Standard Deviation 0.13
|
5.20 mg/dL
Standard Deviation 0.13
|
5.10 mg/dL
Standard Deviation 0.20
|
5.01 mg/dL
Standard Deviation 0.14
|
|
Ionized Calcium Over Time
Day 29
|
5.05 mg/dL
Standard Deviation 0.08
|
4.92 mg/dL
Standard Deviation 0.17
|
5.02 mg/dL
Standard Deviation 0.20
|
4.85 mg/dL
Standard Deviation 0.08
|
5.22 mg/dL
Standard Deviation 0.12
|
5.03 mg/dL
Standard Deviation 0.16
|
5.28 mg/dL
Standard Deviation 0.17
|
5.22 mg/dL
Standard Deviation 0.10
|
5.13 mg/dL
Standard Deviation 0.20
|
5.13 mg/dL
Standard Deviation 0.17
|
|
Ionized Calcium Over Time
Day 1 Pre-dose
|
4.95 mg/dL
Standard Deviation 0.18
|
5.02 mg/dL
Standard Deviation 0.16
|
5.01 mg/dL
Standard Deviation 0.18
|
4.88 mg/dL
Standard Deviation 0.08
|
5.07 mg/dL
Standard Deviation 0.18
|
4.85 mg/dL
Standard Deviation 0.10
|
5.30 mg/dL
Standard Deviation 0.12
|
5.18 mg/dL
Standard Deviation 0.15
|
5.27 mg/dL
Standard Deviation 0.15
|
5.02 mg/dL
Standard Deviation 0.20
|
|
Ionized Calcium Over Time
Day 1 Hour 6
|
4.93 mg/dL
Standard Deviation 0.10
|
4.98 mg/dL
Standard Deviation 0.10
|
4.97 mg/dL
Standard Deviation 0.21
|
4.93 mg/dL
Standard Deviation 0.08
|
5.06 mg/dL
Standard Deviation 0.24
|
4.87 mg/dL
Standard Deviation 0.12
|
5.10 mg/dL
Standard Deviation 0.14
|
5.28 mg/dL
Standard Deviation 0.15
|
5.30 mg/dL
Standard Deviation 0.09
|
4.97 mg/dL
Standard Deviation 0.19
|
|
Ionized Calcium Over Time
Day 1 Hour 8
|
4.92 mg/dL
Standard Deviation 0.15
|
5.00 mg/dL
Standard Deviation 0.11
|
5.00 mg/dL
Standard Deviation 0.21
|
4.90 mg/dL
Standard Deviation 0.06
|
5.04 mg/dL
Standard Deviation 0.27
|
4.78 mg/dL
Standard Deviation 0.12
|
5.30 mg/dL
Standard Deviation 0.08
|
5.28 mg/dL
Standard Deviation 0.17
|
5.30 mg/dL
Standard Deviation 0.09
|
4.93 mg/dL
Standard Deviation 0.14
|
|
Ionized Calcium Over Time
Day 1 Hour 10
|
5.00 mg/dL
Standard Deviation 0.09
|
5.05 mg/dL
Standard Deviation 0.10
|
5.11 mg/dL
Standard Deviation 0.19
|
4.95 mg/dL
Standard Deviation 0.15
|
5.07 mg/dL
Standard Deviation 0.34
|
4.88 mg/dL
Standard Deviation 0.12
|
5.30 mg/dL
Standard Deviation 0.12
|
5.32 mg/dL
Standard Deviation 0.18
|
5.38 mg/dL
Standard Deviation 0.15
|
5.06 mg/dL
Standard Deviation 0.20
|
|
Ionized Calcium Over Time
Day 15
|
5.10 mg/dL
Standard Deviation 0.19
|
4.92 mg/dL
Standard Deviation 0.12
|
5.02 mg/dL
Standard Deviation 0.16
|
4.83 mg/dL
Standard Deviation 0.12
|
4.98 mg/dL
Standard Deviation 0.19
|
5.00 mg/dL
Standard Deviation 0.06
|
5.20 mg/dL
Standard Deviation 0.22
|
5.25 mg/dL
Standard Deviation 0.12
|
5.07 mg/dL
Standard Deviation 0.12
|
5.05 mg/dL
Standard Deviation 0.16
|
|
Ionized Calcium Over Time
Day 22
|
5.05 mg/dL
Standard Deviation 0.18
|
4.82 mg/dL
Standard Deviation 0.12
|
4.92 mg/dL
Standard Deviation 0.16
|
4.85 mg/dL
Standard Deviation 0.08
|
5.08 mg/dL
Standard Deviation 0.17
|
5.05 mg/dL
Standard Deviation 0.08
|
5.18 mg/dL
Standard Deviation 0.24
|
5.12 mg/dL
Standard Deviation 0.15
|
5.05 mg/dL
Standard Deviation 0.21
|
5.03 mg/dL
Standard Deviation 0.17
|
|
Ionized Calcium Over Time
Day 36
|
—
|
—
|
4.96 mg/dL
Standard Deviation 0.14
|
5.07 mg/dL
Standard Deviation 0.16
|
5.11 mg/dL
Standard Deviation 0.18
|
4.96 mg/dL
Standard Deviation 0.16
|
5.28 mg/dL
Standard Deviation 0.13
|
5.18 mg/dL
Standard Deviation 0.10
|
5.18 mg/dL
Standard Deviation 0.15
|
5.16 mg/dL
Standard Deviation 0.17
|
|
Ionized Calcium Over Time
Day 43
|
—
|
—
|
4.99 mg/dL
Standard Deviation 0.15
|
5.22 mg/dL
Standard Deviation 0.13
|
5.26 mg/dL
Standard Deviation 0.21
|
5.02 mg/dL
Standard Deviation 0.08
|
5.23 mg/dL
Standard Deviation 0.17
|
5.30 mg/dL
Standard Deviation 0.13
|
5.18 mg/dL
Standard Deviation 0.12
|
5.18 mg/dL
Standard Deviation 0.23
|
|
Ionized Calcium Over Time
Day 50
|
—
|
—
|
5.19 mg/dL
Standard Deviation 0.16
|
5.20 mg/dL
Standard Deviation 0.11
|
5.16 mg/dL
Standard Deviation 0.11
|
5.00 mg/dL
Standard Deviation 0.13
|
5.28 mg/dL
Standard Deviation 0.15
|
5.32 mg/dL
Standard Deviation 0.13
|
5.15 mg/dL
Standard Deviation 0.14
|
5.21 mg/dL
Standard Deviation 0.19
|
|
Ionized Calcium Over Time
Day 57
|
—
|
—
|
5.22 mg/dL
Standard Deviation 0.14
|
5.22 mg/dL
Standard Deviation 0.10
|
5.21 mg/dL
Standard Deviation 0.15
|
5.18 mg/dL
Standard Deviation 0.13
|
5.33 mg/dL
Standard Deviation 0.17
|
5.23 mg/dL
Standard Deviation 0.08
|
5.25 mg/dL
Standard Deviation 0.15
|
5.26 mg/dL
Standard Deviation 0.14
|
|
Ionized Calcium Over Time
Day 64
|
—
|
—
|
—
|
—
|
5.22 mg/dL
Standard Deviation 0.18
|
5.13 mg/dL
Standard Deviation 0.14
|
5.15 mg/dL
Standard Deviation 0.07
|
—
|
5.17 mg/dL
Standard Deviation 0.14
|
5.18 mg/dL
Standard Deviation 0.11
|
|
Ionized Calcium Over Time
Day 71
|
—
|
—
|
—
|
—
|
5.38 mg/dL
Standard Deviation 0.16
|
5.12 mg/dL
Standard Deviation 0.18
|
5.30 mg/dL
Standard Deviation 0.28
|
—
|
5.20 mg/dL
Standard Deviation 0.13
|
5.18 mg/dL
Standard Deviation 0.08
|
|
Ionized Calcium Over Time
Day 78
|
—
|
—
|
—
|
—
|
5.30 mg/dL
Standard Deviation 0.17
|
5.15 mg/dL
Standard Deviation 0.19
|
5.15 mg/dL
Standard Deviation 0.07
|
—
|
5.27 mg/dL
Standard Deviation 0.15
|
5.28 mg/dL
Standard Deviation 0.08
|
|
Ionized Calcium Over Time
Day 85
|
—
|
—
|
—
|
—
|
5.36 mg/dL
Standard Deviation 0.13
|
5.13 mg/dL
Standard Deviation 0.22
|
5.20 mg/dL
Standard Deviation 0.14
|
—
|
5.23 mg/dL
Standard Deviation 0.14
|
5.24 mg/dL
Standard Deviation 0.11
|
Adverse Events
Placebo SC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Romosozumab 0.1 mg/kg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Romosozumab 0.3 mg/kg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Romosozumab 1.0 mg/kg SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Romosozumab 10.0 mg/kg SC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Romosozumab 3.0 mg/kg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Romosozumab 5.0 mg/kg SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Romosozumab 1.0 mg/kg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Romosozumab 5.0 mg/kg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SC
n=14 participants at risk
Participants received a single subcutaneous (SC) injection of matching placebo.
|
Placebo IV
n=4 participants at risk
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 0.1 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 participants at risk
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 participants at risk
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg IV
n=6 participants at risk
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 participants at risk
Participants received a single intravenous injection of 5.0 mg/kg romosozumab.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo SC
n=14 participants at risk
Participants received a single subcutaneous (SC) injection of matching placebo.
|
Placebo IV
n=4 participants at risk
Participants received a single intravenous (IV) injection of matching placebo.
|
Romosozumab 0.1 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
|
Romosozumab 0.3 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg SC
n=9 participants at risk
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 10.0 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
|
Romosozumab 3.0 mg/kg SC
n=6 participants at risk
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg SC
n=9 participants at risk
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
|
Romosozumab 1.0 mg/kg IV
n=6 participants at risk
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
|
Romosozumab 5.0 mg/kg IV
n=6 participants at risk
Participants received a single intravenous injection of 5.0 mg/kg romosozumab.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
TINEA PEDIS
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
2/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
LIP DRY
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
NAUSEA
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
ASTHENIA
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
CHEST PAIN
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
4/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
2/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
2/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE REACTION
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
THIRST
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
2/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.3%
2/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
14.3%
2/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
DIZZINESS
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
HEADACHE
|
21.4%
3/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
BREAST TENDERNESS
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
1/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
7.1%
1/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/14 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/9 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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