Trial Outcomes & Findings for Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta (NCT NCT04545554)
NCT ID: NCT04545554
Last Updated: 2024-04-15
Results Overview
Mean Cmax values following Days 1 and 57 are presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57
Results posted on
2024-04-15
Participant Flow
Participants were enrolled at 15 study centers in Austria, Germany, Greece, Hungary, Italy, Spain, Turkey, and the United States, and participated from 21 January 2021 until 30 March 2023.
Ambulatory children (5 to \< 12 years of age) and adolescents (12 to \< 18 years of age) with osteogenesis imperfecta were enrolled to receive 1 of 3 subcutaneous (SC) dose levels of romosozumab. Specific doses are blinded due to the protection of propriety information.
Participant milestones
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
5
|
4
|
4
|
|
Overall Study
Received at Least 1 Dose Romosozumab
|
4
|
4
|
4
|
5
|
4
|
4
|
|
Overall Study
Received All Doses of Romosozumab
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
Baseline characteristics by cohort
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
6.0 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
14.3 years
STANDARD_DEVIATION 0.5 • n=206 Participants
|
8.4 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 1.8 • n=31 Participants
|
6.5 years
STANDARD_DEVIATION 0.6 • n=30 Participants
|
10.5 years
STANDARD_DEVIATION 4.0 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
Asian
|
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
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57Population: Pharmacokinetic (PK) Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
Mean Cmax values following Days 1 and 57 are presented.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Romosozumab
Day 1
|
2.64 μg/mL
Standard Deviation 1.06
|
1.74 μg/mL
Standard Deviation 0.825
|
13.8 μg/mL
Standard Deviation 6.32
|
10.3 μg/mL
Standard Deviation 1.70
|
25.7 μg/mL
Standard Deviation 3.02
|
21.3 μg/mL
Standard Deviation 6.45
|
|
Maximum Observed Serum Concentration (Cmax) of Romosozumab
Day 57
|
2.43 μg/mL
Standard Deviation 1.36
|
5.55 μg/mL
Standard Deviation 2.11
|
12.8 μg/mL
Standard Deviation 6.31
|
9.14 μg/mL
Standard Deviation 7.50
|
22.8 μg/mL
Standard Deviation 10.5
|
19.4 μg/mL
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
Median tmax values following Days 1 and 57 are presented.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Romosozumab
Day 1
|
6.5 day
Interval 5.9 to 7.9
|
7.9 day
Interval 7.9 to 15.0
|
6.9 day
Interval 6.9 to 7.0
|
6.9 day
Interval 4.9 to 7.1
|
7.0 day
Interval 4.9 to 8.0
|
7.5 day
Interval 6.9 to 8.9
|
|
Time to Cmax (Tmax) of Romosozumab
Day 57
|
7.0 day
Interval 7.0 to 12.0
|
7.0 day
Interval 6.9 to 7.0
|
7.0 day
Interval 6.0 to 7.9
|
8.0 day
Interval 6.0 to 11.0
|
7.0 day
Interval 4.0 to 12.0
|
7.5 day
Interval 6.0 to 8.8
|
PRIMARY outcome
Timeframe: Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
Mean AUC(0-28) values following Days 1 and 57 are presented.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab
Day 1
|
30.9 day*μg/mL
Standard Deviation 13.5
|
16.9 day*μg/mL
Standard Deviation 5.78
|
163 day*μg/mL
Standard Deviation 89.1
|
113 day*μg/mL
Standard Deviation 50.3
|
344 day*μg/mL
Standard Deviation 106
|
234 day*μg/mL
Standard Deviation 93.7
|
|
Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab
Day 57
|
27.4 day*μg/mL
Standard Deviation 15.1
|
50.5 day*μg/mL
Standard Deviation 20.7
|
153 day*μg/mL
Standard Deviation 86.7
|
95.1 day*μg/mL
Standard Deviation 76.1
|
293 day*μg/mL
Standard Deviation 134
|
203 day*μg/mL
Standard Deviation 40.7
|
PRIMARY outcome
Timeframe: Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.
The accumulation ratio was calculated as AUC(0-28) at Day 57/AUC(0-28) at Day 1. Mean accumulation ratio values based on analysis at Days 1 and 57 are presented, as pre-specified.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Accumulation Ratio of Romosozumab
|
0.885 ratio
Standard Deviation 0.487
|
3.6 ratio
Standard Deviation 2.56
|
0.922 ratio
Standard Deviation 0.0673
|
0.724 ratio
Standard Deviation 0.392
|
0.843 ratio
Standard Deviation 0.260
|
0.935 ratio
Standard Deviation 0.283
|
PRIMARY outcome
Timeframe: Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Day 57Population: PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. Data is presented for participants with evaluable data.
Median terminal half-life values at Day 57 are presented.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=2 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=1 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=3 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Terminal Half-life of Romosozumab
|
—
|
9.41 day
Interval 7.62 to 11.2
|
—
|
7.01 day
Interval 7.01 to 7.01
|
6.11 day
Interval 5.58 to 6.56
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of study (up to Day 169); median duration on study was 5.55 monthsPopulation: Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.
TEAEs were adverse events (AEs) that started on or after first dose of investigational product up to the end of study (up to Day 169). Any clinically significant changes in vital signs, electrocardiogram parameters, physical exam findings, and clinical laboratory parameters were reported as TEAEs. Injection site reactions were events of interest (EOI) for this study.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any Treatment-emergent EOI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 57, Day 85, and Day 169Population: Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product. Participants with data available at each time point are presented.
Facial nerve (cranial nerve VII) function was assessed clinically by facial symmetry inspection at rest, followed by assessment of the symmetry of specific facial movements: raising eyebrows, closing the eyes, blowing out the cheeks, smiling, pursing and closing the lips. Results of the cranial nerve examination were classed as 0 = Normal; 1 = Abnormal not clinically significant; and 2 = Abnormal clinically significant. An increase from baseline indicates an increase in abnormal clinical findings on the cranial nerve VII examination.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Blowing out of cheeks - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Smiling - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Smiling - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Blowing out of cheeks - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Closing eyes - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Closing eyes - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Closing of lips - No change (0)
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Closing of lips - Increase (to 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Closing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Raising eyebrows - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Closing of lips - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Closing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Raising eyebrows - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Raising eyebrows - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Smiling - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Blowing out of cheeks - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Closing eyes - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Closing eyes - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Closing of lips - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Closing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Pursing of lips - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Pursing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Raising eyebrows - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 57: Raising eyebrows - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Blowing out of cheeks - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Blowing out of cheeks - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Pursing of lips - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Pursing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Raising eyebrows - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Smiling - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 85: Smiling - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Blowing out of cheeks - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Closing eyes - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Closing eyes - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Pursing of lips - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Pursing of lips - Undetermined
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169
Day 169: Smiling - No change (0)
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169Population: Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.
Treatment-boosted anti-romosozumab antibody was defined as binding antibody positive at baseline with a \>4 x increase in magnitude post-baseline. Transient results were defined as negative results at the participant's last time point tested within the study period.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-romosozumab Antibodies
Binding antibody positive at/before baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Neutralizing antibody positive at/before baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Neutralizing antibody positive post-baseline with a negative/no result at baseline
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Transient neutralizing antibody positive post-baseline with a negative/no result at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Binding antibody positive anytime
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Neutralizing antibody positive anytime
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Treatment-boosted antibody positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Binding antibody positive post-baseline with negative/no results at baseline
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Anti-romosozumab Antibodies
Transient binding antibody positive post-baseline with negative/no results at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169Population: PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented.
Serum concentrations of the bone turnover marker CTX were determined at pre-specified time points.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 8
|
2.65 percentage change
Standard Deviation 27.91
|
-19.93 percentage change
Standard Deviation 33.97
|
8.79 percentage change
Standard Deviation 19.21
|
-19.38 percentage change
Standard Deviation 20.01
|
-12.33 percentage change
Standard Deviation 12.93
|
7.14 percentage change
Standard Deviation 29.89
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 29
|
-4.67 percentage change
Standard Deviation 21.35
|
-6.67 percentage change
Standard Deviation 39.99
|
26.00 percentage change
Standard Deviation 15.11
|
-7.43 percentage change
Standard Deviation 18.63
|
-16.09 percentage change
Standard Deviation 27.05
|
3.76 percentage change
Standard Deviation 24.72
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 57
|
1.03 percentage change
Standard Deviation 34.14
|
-7.34 percentage change
Standard Deviation 25.32
|
-0.32 percentage change
Standard Deviation 32.21
|
-7.66 percentage change
Standard Deviation 13.16
|
-1.40 percentage change
Standard Deviation 38.10
|
44.17 percentage change
Standard Deviation 95.30
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 85
|
-10.56 percentage change
Standard Deviation 22.18
|
-37.50 percentage change
Standard Deviation 14.12
|
9.95 percentage change
Standard Deviation 30.71
|
5.08 percentage change
Standard Deviation 24.34
|
0.71 percentage change
Standard Deviation 44.55
|
15.77 percentage change
Standard Deviation 58.40
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 113
|
-3.83 percentage change
Standard Deviation 22.30
|
-30.38 percentage change
Standard Deviation 19.59
|
25.94 percentage change
Standard Deviation 39.76
|
6.98 percentage change
Standard Deviation 37.98
|
7.03 percentage change
Standard Deviation 40.23
|
-19.58 percentage change
Standard Deviation 10.98
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 169
|
-6.15 percentage change
Standard Deviation 54.87
|
-29.78 percentage change
Standard Deviation 31.60
|
-1.72 percentage change
Standard Deviation 40.42
|
11.08 percentage change
Standard Deviation 16.19
|
-8.07 percentage change
Standard Deviation 16.73
|
8.08 percentage change
Standard Deviation 49.45
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 15
|
12.26 percentage change
Standard Deviation 28.20
|
-3.24 percentage change
Standard Deviation 41.30
|
-2.14 percentage change
Standard Deviation 52.91
|
-20.24 percentage change
Standard Deviation 21.12
|
-17.22 percentage change
Standard Deviation 17.39
|
42.62 percentage change
Standard Deviation 54.95
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 64
|
-13.37 percentage change
Standard Deviation 36.33
|
-18.26 percentage change
Standard Deviation 49.19
|
19.91 percentage change
Standard Deviation 43.95
|
-10.60 percentage change
Standard Deviation 36.12
|
10.95 percentage change
Standard Deviation 23.38
|
-28.14 percentage change
Standard Deviation 11.51
|
|
Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)
Day 71
|
18.20 percentage change
Standard Deviation 53.85
|
-25.30 percentage change
Standard Deviation 50.43
|
35.26 percentage change
Standard Deviation 68.16
|
-3.37 percentage change
Standard Deviation 8.25
|
15.14 percentage change
Standard Deviation 51.39
|
60.12 percentage change
Standard Deviation 106.28
|
SECONDARY outcome
Timeframe: Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169Population: PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented.
Serum concentrations of the bone turnover marker P1NP were determined at pre-specified time points.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 8
|
19.81 percentage change
Standard Deviation 20.96
|
12.75 percentage change
Standard Deviation 13.03
|
65.12 percentage change
Standard Deviation 17.75
|
31.77 percentage change
Standard Deviation 11.69
|
35.91 percentage change
Standard Deviation 21.89
|
35.35 percentage change
Standard Deviation 47.08
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 29
|
5.24 percentage change
Standard Deviation 12.87
|
6.18 percentage change
Standard Deviation 18.64
|
21.52 percentage change
Standard Deviation 25.01
|
1.96 percentage change
Standard Deviation 9.22
|
32.13 percentage change
Standard Deviation 59.10
|
-11.54 percentage change
Standard Deviation 11.35
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 57
|
-2.11 percentage change
Standard Deviation 20.26
|
-22.37 percentage change
Standard Deviation 19.82
|
14.57 percentage change
Standard Deviation 36.09
|
-6.36 percentage change
Standard Deviation 17.51
|
19.07 percentage change
Standard Deviation 56.24
|
-14.26 percentage change
Standard Deviation 12.93
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 64
|
14.82 percentage change
Standard Deviation 28.86
|
19.12 percentage change
Standard Deviation 40.48
|
39.63 percentage change
Standard Deviation 31.92
|
25.42 percentage change
Standard Deviation 16.73
|
77.17 percentage change
Standard Deviation 109.07
|
17.51 percentage change
Standard Deviation 35.74
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 113
|
-1.13 percentage change
Standard Deviation 13.42
|
-13.75 percentage change
Standard Deviation 19.11
|
21.10 percentage change
Standard Deviation 40.61
|
2.53 percentage change
Standard Deviation 42.46
|
-5.02 percentage change
Standard Deviation 21.00
|
-26.95 percentage change
Standard Deviation 10.23
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 169
|
-6.62 percentage change
Standard Deviation 30.96
|
-3.13 percentage change
Standard Deviation 10.54
|
18.10 percentage change
Standard Deviation 57.53
|
-2.24 percentage change
Standard Deviation 23.99
|
-14.30 percentage change
Standard Deviation 19.41
|
-21.85 percentage change
Standard Deviation 16.18
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 15
|
11.03 percentage change
Standard Deviation 13.94
|
12.43 percentage change
Standard Deviation 13.07
|
52.25 percentage change
Standard Deviation 29.71
|
10.52 percentage change
Standard Deviation 14.72
|
58.58 percentage change
Standard Deviation 54.61
|
28.35 percentage change
Standard Deviation 55.00
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 71
|
12.19 percentage change
Standard Deviation 21.37
|
-5.72 percentage change
Standard Deviation 28.50
|
49.37 percentage change
Standard Deviation 37.99
|
16.79 percentage change
Standard Deviation 12.29
|
42.16 percentage change
Standard Deviation 59.39
|
5.12 percentage change
Standard Deviation 29.54
|
|
Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)
Day 85
|
-7.34 percentage change
Standard Deviation 22.50
|
-23.50 percentage change
Standard Deviation 13.42
|
26.12 percentage change
Standard Deviation 48.97
|
-0.72 percentage change
Standard Deviation 21.29
|
5.79 percentage change
Standard Deviation 23.45
|
-11.78 percentage change
Standard Deviation 30.09
|
SECONDARY outcome
Timeframe: DXA scans were during screening (baseline) and at Day 85 and Day 169Population: The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.
BMD was assessed by dual energy X-ray absorptiometry (DXA) scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine
Day 85
|
4.84 percentage change
Standard Deviation 3.29
|
7.94 percentage change
Standard Deviation 5.32
|
12.91 percentage change
Standard Deviation 2.60
|
7.78 percentage change
Standard Deviation 9.16
|
7.88 percentage change
Standard Deviation 1.99
|
13.07 percentage change
Standard Deviation 13.45
|
|
Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine
Day 169
|
7.80 percentage change
Standard Deviation 2.23
|
9.24 percentage change
Standard Deviation 7.98
|
15.04 percentage change
Standard Deviation 4.32
|
7.09 percentage change
Standard Deviation 7.03
|
7.10 percentage change
Standard Deviation 6.58
|
12.70 percentage change
Standard Deviation 12.86
|
SECONDARY outcome
Timeframe: DXA scans were during screening (baseline) and at Day 85 and Day 169Population: The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.
BMC was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine
Day 85
|
7.68 percentage change
Standard Deviation 8.10
|
10.13 percentage change
Standard Deviation 6.05
|
18.16 percentage change
Standard Deviation 7.86
|
8.41 percentage change
Standard Deviation 6.90
|
14.62 percentage change
Standard Deviation 3.39
|
16.03 percentage change
Standard Deviation 8.32
|
|
Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine
Day 169
|
12.64 percentage change
Standard Deviation 4.07
|
11.40 percentage change
Standard Deviation 7.82
|
21.29 percentage change
Standard Deviation 11.31
|
7.98 percentage change
Standard Deviation 7.77
|
14.27 percentage change
Standard Deviation 5.52
|
12.42 percentage change
Standard Deviation 10.72
|
SECONDARY outcome
Timeframe: DXA scans were during screening (baseline) and at Day 85 and Day 169Population: The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement.
Bone area was assessed by DXA scans of the anteroposterior lumbar spine (L1 through L4) and analyzed by a central imaging laboratory. At least 2 lumbar vertebrae from L1 - L4 must be evaluable by DXA.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine Bone Area
Day 85
|
2.72 percentage change
Standard Deviation 6.99
|
2.03 percentage change
Standard Deviation 1.62
|
4.60 percentage change
Standard Deviation 5.00
|
0.80 percentage change
Standard Deviation 4.62
|
6.23 percentage change
Standard Deviation 2.15
|
3.44 percentage change
Standard Deviation 11.05
|
|
Percentage Change From Baseline in Lumbar Spine Bone Area
Day 169
|
4.53 percentage change
Standard Deviation 4.92
|
1.92 percentage change
Standard Deviation 0.66
|
5.30 percentage change
Standard Deviation 6.06
|
0.82 percentage change
Standard Deviation 1.95
|
6.87 percentage change
Standard Deviation 5.14
|
-0.09 percentage change
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: DXA scans were during screening (baseline) and at Day 85 and Day 169Population: The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.
Lumbar spine BMD was assessed by DXA scans. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from baseline indicated an improvement in lumbar spine BMD.
Outcome measures
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 Participants
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 Participants
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Lumbar Spine BMD Z-Score
Day 85
|
0.20 Z-score
Standard Deviation 0.39
|
0.45 Z-score
Standard Deviation 0.37
|
0.50 Z-score
Standard Deviation 0.12
|
0.33 Z-score
Standard Deviation 0.53
|
0.33 Z-score
Standard Deviation 0.26
|
0.53 Z-score
Standard Deviation 0.79
|
|
Mean Change From Baseline in Lumbar Spine BMD Z-Score
Day 169
|
0.33 Z-score
Standard Deviation 0.46
|
0.48 Z-score
Standard Deviation 0.51
|
0.48 Z-score
Standard Deviation 0.21
|
0.25 Z-score
Standard Deviation 0.39
|
0.23 Z-score
Standard Deviation 0.56
|
0.50 Z-score
Standard Deviation 0.62
|
Adverse Events
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 participants at risk
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
Other adverse events
| Measure |
Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose A (low dose).
|
Cohort 3: Romosozumab Dose B (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 4: Romosozumab Dose B (5 to < 12 Years of Age)
n=5 participants at risk
Participants received multiple SC doses of romosozumab Dose B (medium dose).
|
Cohort 5: Romosozumab Dose C (12 to < 18 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
Cohort 6: Romosozumab Dose C (5 to < 12 Years of Age)
n=4 participants at risk
Participants received multiple SC doses of romosozumab Dose C (high dose).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
General disorders
Injection site swelling
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
50.0%
2/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
50.0%
2/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
50.0%
2/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
50.0%
2/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
25.0%
1/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
20.0%
1/5 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
0.00%
0/4 • All-cause mortality was collected from enrollment to the end of study visit (Day 169); median time on study was 5.55 months. Adverse events were collected from first dose of study drug until the end of study visit (Day 169); median duration was 5.55 months.
|
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