Trial Outcomes & Findings for Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function (NCT NCT05001269)
NCT ID: NCT05001269
Last Updated: 2026-04-16
Results Overview
This outcome measure reported percent change from baseline to Month 6 in spot urinary oxalate-to-creatinine ratio in pediatric participants (birth to 11 years of age) with genetically confirmed primary hyperoxaluria type 1 (PH1), primary hyperoxaluria type 2 (PH2), or primary hyperoxaluria type 3 (PH3) subgroups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline (Week 0), Month 6
Results posted on
2026-04-16
Participant Flow
The study was conducted at 13 sites in 9 countries.
This is Phase 2, open-label, single-arm uncontrolled study in pediatric participants with genetically confirmed primary hyperoxaluria (PH), with relatively intact renal function based upon estimated glomerular filtration rate (eGFR) and serum creatinine.
Participant milestones
| Measure |
Children 0 to <2 Years
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 6 to 11 Years
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
13
|
9
|
|
Overall Study
Modified Intent-To-Treat (MITT)
|
5
|
13
|
9
|
|
Overall Study
Safety
|
5
|
13
|
9
|
|
Overall Study
COMPLETED
|
5
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function
Baseline characteristics by cohort
| Measure |
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
11 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
|
Age, Continuous
|
1.30 years
STANDARD_DEVIATION 0.529 • n=193 Participants
|
3.54 years
STANDARD_DEVIATION 1.198 • n=193 Participants
|
7.78 years
STANDARD_DEVIATION 1.093 • n=386 Participants
|
4.54 years
STANDARD_DEVIATION 2.687 • n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
11 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
16 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
24 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
6 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
9 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Month 6Population: The MITT Population included all participants who received at least 1 dose of study intervention and have at least 1 post-baseline spot urinary oxalate to creatinine ratio. Here 'Number of participant analyzed' signified 'Overall number of participants analyzed' and 'Number Analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported percent change from baseline to Month 6 in spot urinary oxalate-to-creatinine ratio in pediatric participants (birth to 11 years of age) with genetically confirmed primary hyperoxaluria type 1 (PH1), primary hyperoxaluria type 2 (PH2), or primary hyperoxaluria type 3 (PH3) subgroups.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Percent Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH1
|
-61.44 Percent change
Standard Deviation 24.565
|
-74.06 Percent change
Standard Deviation 13.193
|
-68.34 Percent change
Standard Deviation 8.574
|
|
Percent Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH2
|
-16.10 Percent change
Standard Deviation 0
|
—
|
-17.98 Percent change
Standard Deviation 37.847
|
|
Percent Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH3
|
—
|
-41.43 Percent change
Standard Deviation 13.633
|
—
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Month 6Population: The MITT Population included all participants who received at least 1 dose of study intervention and have at least 1 post-baseline spot urinary oxalate to creatinine ratio. Here 'Number of participant analyzed' signified 'Overall number of participants analyzed' and 'Number Analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported absolute change from baseline to Month 6 in spot urinary oxalate-to-creatinine ratio in pediatric participants (birth to 11 years of age) with genetically confirmed PH1, PH2, or PH3 subgroups.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Absolute Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH1
|
-189.106 micromole/millimole
Standard Deviation 120.5939
|
-563.972 micromole/millimole
Standard Deviation 378.3308
|
-316.344 micromole/millimole
Standard Deviation 150.6332
|
|
Absolute Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH2
|
-27.583 micromole/millimole
Standard Deviation 0
|
—
|
-64.458 micromole/millimole
Standard Deviation 92.5196
|
|
Absolute Change From Baseline to Month 6 in Spot Urinary Oxalate-to-creatinine Ratio in PH1, PH2, or PH3 Participant Subgroups
PH3
|
—
|
-135.283 micromole/millimole
Standard Deviation 17.1591
|
—
|
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported number of incidents of TEAEs and SAEs. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and medical events. An AE will be defined as treatment emergent if they have an onset or worsen in severity after a participant receives the study intervention.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
38 Events
|
37 Events
|
66 Events
|
|
Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Events
|
1 Events
|
4 Events
|
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported nature of TEAEs and SAEs. An AE is any untoward medical occurrence in clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and medical events. An AE is treatment emergent if they have an onset or worsen in severity after a participant receives the study intervention. TEAEs are considered as leading to discontinuation if the action taken is marked as "drug withdrawn" on the case report form. TEAEs of special interest include injection site reactions, muscle pain and weakness, and kidney stone events.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
Treatment Related TEAEs
|
4 Events
|
2 Events
|
7 Events
|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
TEAEs Leading to Treatment Interruption
|
0 Events
|
1 Events
|
0 Events
|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
TEAEs Leading to Treatment Discontinuation
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
TEAEs of Special Interest
|
8 Events
|
7 Events
|
8 Events
|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
Serious Treatment Related TEAEs
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Treatment Emergent Adverse Events and Serious Adverse Events-Nature
Fatal TEAEs
|
0 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in ECG mean heart rate.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead Electrocardiogram (ECG)- ECG Mean Heart Rate
|
6.2 beats/minute
Standard Deviation 16.98
|
-11.6 beats/minute
Standard Deviation 32.34
|
-4.2 beats/minute
Standard Deviation 15.73
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in RR Interval.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead ECG- RR Interval
|
-0.1 seconds
Standard Deviation 0.12
|
0.1 seconds
Standard Deviation 0.16
|
0.0 seconds
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in aggregate PR Interval.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead ECG-PR Interval, Aggregate
|
-1.0 milliseconds
Standard Deviation 8.75
|
3.6 milliseconds
Standard Deviation 8.56
|
1.8 milliseconds
Standard Deviation 6.39
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in aggregate QRS Interval.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead ECG-QRS Duration, Aggregate
|
1.7 milliseconds
Standard Deviation 3.24
|
3.2 milliseconds
Standard Deviation 5.45
|
0.5 milliseconds
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in aggregate QT Interval.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead ECG-QT Interval, Aggregate
|
-6.7 milliseconds
Standard Deviation 23.69
|
28.0 milliseconds
Standard Deviation 30.60
|
8.2 milliseconds
Standard Deviation 20.46
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in aggregate QTcF Interval.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in 12-lead ECG-QTcF Interval, Aggregate
|
1.8 milliseconds
Standard Deviation 13.29
|
21.0 milliseconds
Standard Deviation 17.68
|
4.5 milliseconds
Standard Deviation 14.88
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in number of participants with significant findings (physical examination). Change from baseline was calculated using formula: value at current time point - baseline value.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Participants With Significant Findings- Physical Examination
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants heights.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment- Height
|
2.76 centimeters
Standard Deviation 1.548
|
6.24 centimeters
Standard Deviation 2.220
|
4.01 centimeters
Standard Deviation 1.237
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants weights.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Weight
|
2.411 kilograms (kg)
Standard Deviation 1.4575
|
1.130 kilograms (kg)
Standard Deviation 0.3033
|
1.488 kilograms (kg)
Standard Deviation 1.2636
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants BMI.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Body Mass Index (BMI)
|
0.608 Kilograms per meter square (kg/m^2)
Standard Deviation 0.9316
|
-0.668 Kilograms per meter square (kg/m^2)
Standard Deviation 0.8318
|
0.152 Kilograms per meter square (kg/m^2)
Standard Deviation 0.9265
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants oral body temperature.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Oral Body Temperature
|
-0.00 degree celcius (˚C)
Standard Deviation 0.339
|
0.36 degree celcius (˚C)
Standard Deviation 0.555
|
-0.01 degree celcius (˚C)
Standard Deviation 0.441
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants respiratory rate.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Respiratory Rate
|
0.8 breaths/minute
Standard Deviation 2.44
|
-1.4 breaths/minute
Standard Deviation 6.77
|
-1.8 breaths/minute
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants heart rate.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Heart Rate
|
4.7 beats/minute
Standard Deviation 16.96
|
6.2 beats/minute
Standard Deviation 14.13
|
-1.5 beats/minute
Standard Deviation 12.52
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in participants systolic and diastolic blood pressure.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign Assessment-Systolic Blood Pressure and Diastolic Blood Pressure
Systolic Blood Pressure
|
2.8 Millimeters of Mercury (mmHg)
Standard Deviation 7.95
|
6.8 Millimeters of Mercury (mmHg)
Standard Deviation 22.20
|
-6.8 Millimeters of Mercury (mmHg)
Standard Deviation 17.21
|
|
Change From Baseline in Vital Sign Assessment-Systolic Blood Pressure and Diastolic Blood Pressure
Diastolic Blood Pressure
|
2.8 Millimeters of Mercury (mmHg)
Standard Deviation 4.27
|
7.6 Millimeters of Mercury (mmHg)
Standard Deviation 17.84
|
1.1 Millimeters of Mercury (mmHg)
Standard Deviation 13.62
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants erythrocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Erythrocytes
|
0.055 Tera cells per liter (10^12 cells /L)
Standard Deviation 0.2076
|
0.195 Tera cells per liter (10^12 cells /L)
Standard Deviation 0.3375
|
0.173 Tera cells per liter (10^12 cells /L)
Standard Deviation 0.2765
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants hemoglobin.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Hemoglobin
|
0.250 Grams per deciliter (g/dL)
Standard Deviation 0.7051
|
0.575 Grams per deciliter (g/dL)
Standard Deviation 0.7632
|
0.155 Grams per deciliter (g/dL)
Standard Deviation 0.8092
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants hematocrit.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Hematocrit
|
0.00 Ratio of Hematocrit
Standard Deviation 0.023
|
0.01 Ratio of Hematocrit
Standard Deviation 0.025
|
0.01 Ratio of Hematocrit
Standard Deviation 0.019
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants erythrocytes mean corpuscular volume.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Erythrocytes Mean Corpuscular Volume
|
-0.05 Femtoliter (fL)
Standard Deviation 2.530
|
1.70 Femtoliter (fL)
Standard Deviation 3.818
|
-1.25 Femtoliter (fL)
Standard Deviation 2.393
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants erythrocytes mean corpuscular hemoglobin.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Erythrocytes Mean Corpuscular Hemoglobin
|
0.18 picograms
Standard Deviation 0.738
|
0.25 picograms
Standard Deviation 0.624
|
-0.48 picograms
Standard Deviation 1.244
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participant's erythrocytes mean corpuscular hemoglobin concentration.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Erythrocytes Mean Corpuscular Hemoglobin Concentration
|
0.19 g/dL
Standard Deviation 0.783
|
-0.42 g/dL
Standard Deviation 1.754
|
-0.09 g/dL
Standard Deviation 1.691
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants reticulocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Reticulocytes
|
-0.08 Percentage of Reticulocytes
Standard Deviation 0.443
|
0.15 Percentage of Reticulocytes
Standard Deviation 0.208
|
0.14 Percentage of Reticulocytes
Standard Deviation 0.781
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants platelets.
Outcome measures
| Measure |
Children 6 to 11 Years
n=7 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Haematology Assessment: Platelets
|
-27.7 Giga cells per liter (10^9 cells /L)
Standard Deviation 102.53
|
-1.8 Giga cells per liter (10^9 cells /L)
Standard Deviation 40.87
|
-18.6 Giga cells per liter (10^9 cells /L)
Standard Deviation 62.25
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants mean platelet volume.
Outcome measures
| Measure |
Children 6 to 11 Years
n=7 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Mean Platelet Volume
|
0.03 fL
Standard Deviation 0.553
|
0.05 fL
Standard Deviation 0.507
|
-0.10 fL
Standard Deviation 0.610
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Leukocytes
|
-0.625 10^9 cells /L
Standard Deviation 2.2732
|
-1.460 10^9 cells /L
Standard Deviation 2.1985
|
0.383 10^9 cells /L
Standard Deviation 2.3556
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants lymphocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Lymphocytes
|
-0.577 10^9 cells /L
Standard Deviation 0.9109
|
-1.808 10^9 cells /L
Standard Deviation 2.3547
|
0.429 10^9 cells /L
Standard Deviation 1.1896
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants monocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Monocytes
|
-0.038 10^9 cells /L
Standard Deviation 0.1288
|
-0.013 10^9 cells /L
Standard Deviation 0.2295
|
-0.024 10^9 cells /L
Standard Deviation 0.1306
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants eosinophils.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Eosinophils
|
0.106 10^9 cells /L
Standard Deviation 0.3064
|
0.078 10^9 cells /L
Standard Deviation 0.1441
|
0.029 10^9 cells /L
Standard Deviation 0.1495
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants basophils.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Basophils
|
-0.014 10^9 cells /L
Standard Deviation 0.0320
|
0.035 10^9 cells /L
Standard Deviation 0.0545
|
-0.008 10^9 cells /L
Standard Deviation 0.0606
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in participants neutrophils.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Neutrophils
|
-0.106 10^9 cells /L
Standard Deviation 1.3720
|
-0.165 10^9 cells /L
Standard Deviation 2.1021
|
-0.073 10^9 cells /L
Standard Deviation 1.4642
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in the ratio of lymphocytes/leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Lymphocytes/Leukocytes
|
-2.51 Ratio of Lymphocytes/Leukocytes
Standard Deviation 13.862
|
-10.25 Ratio of Lymphocytes/Leukocytes
Standard Deviation 16.801
|
2.20 Ratio of Lymphocytes/Leukocytes
Standard Deviation 9.901
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in the ratio of monocytes/leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Monocytes/Leukocytes
|
-0.14 Ratio of Monocytes/Leukocytes
Standard Deviation 1.255
|
0.70 Ratio of Monocytes/Leukocytes
Standard Deviation 2.534
|
-0.45 Ratio of Monocytes/Leukocytes
Standard Deviation 1.109
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in the ratio of eosinophils/leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Eosinophils/Leukocytes
|
1.29 Ratio of Eosinophils/Leukocytes
Standard Deviation 3.061
|
1.33 Ratio of Eosinophils/Leukocytes
Standard Deviation 1.531
|
0.22 Ratio of Eosinophils/Leukocytes
Standard Deviation 1.829
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in the ratio of basophils/leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Basophils/Leukocytes
|
-0.09 Ratio of Basophils/Leukocytes
Standard Deviation 0.606
|
0.55 Ratio of Basophils/Leukocytes
Standard Deviation 0.777
|
-0.01 Ratio of Basophils/Leukocytes
Standard Deviation 0.517
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in the ratio of neutrophils/leukocytes.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=11 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Hematology Assessment: Neutrophils/Leukocytes
|
1.50 Ratio of Neutrophils/Leukocytes
Standard Deviation 12.398
|
7.63 Ratio of Neutrophils/Leukocytes
Standard Deviation 14.717
|
-2.31 Ratio of Neutrophils/Leukocytes
Standard Deviation 9.655
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in alanine aminotransferase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase
|
5.1 Units per liter (U/L)
Standard Deviation 4.61
|
-1.8 Units per liter (U/L)
Standard Deviation 4.44
|
14.9 Units per liter (U/L)
Standard Deviation 24.68
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in aspartate aminotransferase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase
|
7.1 U/L
Standard Deviation 6.94
|
-4.0 U/L
Standard Deviation 11.94
|
6.4 U/L
Standard Deviation 13.83
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in lactate dehydrogenase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=4 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=12 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase
|
1.6 U/L
Standard Deviation 23.44
|
-29.3 U/L
Standard Deviation 17.29
|
19.5 U/L
Standard Deviation 67.20
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in glutamate dehydrogenase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Glutamate Dehydrogenase
|
0.06 U/L
Standard Deviation 0.316
|
0.00 U/L
Standard Deviation 0.000
|
0.28 U/L
Standard Deviation 0.601
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in gamma glutamyl transferase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Gamma Glutamyl Transferase
|
1.6 U/L
Standard Deviation 0.92
|
-0.4 U/L
Standard Deviation 4.45
|
1.4 U/L
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in alkaline phosphatase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Alkaline Phosphatase
|
-8.4 U/L
Standard Deviation 14.88
|
-6.6 U/L
Standard Deviation 19.65
|
14.6 U/L
Standard Deviation 37.61
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participant analyzed' signified 'Overall number of participants analyzed' and 'Number Analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported change from baseline to Month 6 in bilirubin and direct bilirubin.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin and Direct Bilirubin
Bilirubin
|
1.23 micromole per liter (umol/L)
Standard Deviation 2.355
|
-0.46 micromole per liter (umol/L)
Standard Deviation 1.389
|
1.62 micromole per liter (umol/L)
Standard Deviation 3.467
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin and Direct Bilirubin
Direct Bilirubin
|
-0.03 micromole per liter (umol/L)
Standard Deviation 0.588
|
-0.07 micromole per liter (umol/L)
Standard Deviation 0.096
|
0.20 micromole per liter (umol/L)
Standard Deviation 1.224
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in protein.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
|
-2.0 Grams per liter (g/L)
Standard Deviation 5.55
|
-0.8 Grams per liter (g/L)
Standard Deviation 6.76
|
0.6 Grams per liter (g/L)
Standard Deviation 3.71
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in albumin.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin
|
-0.2 g/L
Standard Deviation 2.64
|
-0.2 g/L
Standard Deviation 2.17
|
1.2 g/L
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in creatine kinase.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Creatine Kinase
|
5.0 U/L
Standard Deviation 20.34
|
-45.6 U/L
Standard Deviation 58.24
|
9.5 U/L
Standard Deviation 37.12
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention.
This outcome measure reported change from baseline to Month 6 in sodium.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium
|
-0.2 millimole per liter (mmol/L)
Standard Deviation 2.91
|
-0.4 millimole per liter (mmol/L)
Standard Deviation 2.51
|
-0.6 millimole per liter (mmol/L)
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in chloride.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Chloride
|
-0.9 mmol/L
Standard Deviation 2.64
|
-1.0 mmol/L
Standard Deviation 1.22
|
0.4 mmol/L
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in potassium.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Potassium
|
-0.15 mmol/L
Standard Deviation 0.411
|
-0.42 mmol/L
Standard Deviation 0.356
|
-0.11 mmol/L
Standard Deviation 0.571
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in creatinine.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
|
1.26 umol/L
Standard Deviation 1.965
|
0.66 umol/L
Standard Deviation 5.062
|
1.10 umol/L
Standard Deviation 6.327
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in blood urea nitrogen.
Outcome measures
| Measure |
Children 6 to 11 Years
n=8 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Blood Urea Nitrogen
|
-0.11 mmol/L
Standard Deviation 1.082
|
0.56 mmol/L
Standard Deviation 2.016
|
0.06 mmol/L
Standard Deviation 1.999
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participants analyzed' signified number of participant with available data for particular timepoint, in the respective arms.
This outcome measure reported change from baseline to Month 6 in blood urea Cystatin C.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=12 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Cystatin C
|
0.024 milligrams per liter (mg/L)
Standard Deviation 0.1283
|
-0.120 milligrams per liter (mg/L)
Standard Deviation 0.1595
|
-0.026 milligrams per liter (mg/L)
Standard Deviation 0.1962
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: Safety population included all participants who received at least 1 dose of study intervention. Here 'Number of participant analyzed' signified 'Overall number of participants analyzed' and 'Number Analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported change from baseline to Month 6 in blood urea plasma oxalate.
Outcome measures
| Measure |
Children 6 to 11 Years
n=5 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=8 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Plasma Oxalate
PH1
|
-4.400 umol/L
Standard Deviation 4.3932
|
-9.000 umol/L
Standard Deviation 10.5830
|
-5.667 umol/L
Standard Deviation 2.6583
|
|
Change From Baseline in Clinical Chemistry Parameter: Plasma Oxalate
PH3
|
—
|
-2.000 umol/L
Standard Deviation 1.4142
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter: Plasma Oxalate
PH2
|
—
|
—
|
-2.500 umol/L
Standard Deviation 0.7071
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: PK population: All participants who received at least one dose of the study intervention and had at least one evaluable post dose PK assessment. Due to only 2 PK concentration - time data (0 to 4 hrs and 4 to 24 hrs) being available within 24 hours post dose in each participant, Cmax was not calculated. Although the protocol allows for calculation of this parameter if, estimable, reliable estimation was not possible in this study. Consequently, Cmax was not reported in the outcomes.
This outcome measure, if estimable, was expected to report Cmax which is defined as maximum observed concentration. However, in this study, a non-compartmental PK analysis was not planned or executed due to the limited PK samples (2 PK concentration - time data points between 0 to 4 hours and 4 to 24 hours following dose administration on Day 1) collected in pediatric participants per protocol, hence this PK parameter was not estimated. To estimate Cmax, at least one data point prior to Tmax and one data point post-Tmax at the designated time points are needed; however, only two flexible post-dose PK concentration data points were available in this study. Although Cmax was not estimated in this study, the PK data collected in this study will be used in a population PK analysis in the future.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax), if Estimable
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
SECONDARY outcome
Timeframe: Day 1: Postdose 0- to 4-hour and 4- to 24-hour, Days 2, 30, and 90: post dose, Day 150: predose and Day 150: postdose: 0- to 4-hour and 4- to 24-hourPopulation: PK population: All participants who received at least one dose of study intervention and had at least one evaluable post dose PK assessment. Due to only 2 PK concentration-time data (0 to 4hrs and 4 to 24hrs) being available within 24 hours post dose in each participant, AUCt was not calculated. Although the protocol allows for calculation of AUCt if estimable, reliable estimation was not possible in this study. Consequently, AUCt was not reported in the outcomes.
This outcome measure, if estimable, was expected to report AUCt which is defined as area under the concentration-time curve calculated from time zero to the last observable concentration at time t. However, in this study, a non-compartmental PK analysis was not planned or executed due to the limited PK samples (2 PK concentration - time data points between 0 to 4 hours and 4 to 24 hours following dose administration on Day 1) collected in pediatric participants per protocol, hence this PK parameter was not estimated. To estimate AUCt, at least one data point prior to Tmax and three data points post-Tmax at the designated time points are needed; however, only two flexible post-dose PK concentration data points were available in this study. Although AUCt was not estimated in this study, the PK data collected in this study shall be used in a population PK analysis in the future.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Plasma PK Parameters: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt), if Estimable
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
SECONDARY outcome
Timeframe: Day 1: Postdose 0- to 4-hour and 4- to 24-hour, Days 2, 30, and 90: post dose, Day 150: predose and Day 150: post-dose: 0- to 4-hour and 4- to 24-hourPopulation: PK population: All participants who received at least one dose of study intervention and had at least one evaluable post dose PK assessment. Due to only 2 PK concentration-time data (0 to 4hrs and 4 to 24hrs) being available within 24 hours post dose in each participant, AUC∞ was not calculated. Although the protocol allows for calculation of AUC∞ if estimable, reliable estimation was not possible in this study. Consequently, AUC∞ was not reported in the outcomes.
This outcome measure, if estimable, was expected to report AUC∞ which is defined as area under the concentration-time curve calculated to the last observable concentration at time t. However, in this study, a non-compartmental PK analysis was not planned or executed due to the limited PK samples (2 PK concentration - time data points between 0 to 4 hours and 4 to 24 hours following dose administration on Day 1) collected in pediatric participants per protocol, hence this PK parameter was not estimated. To estimate AUC∞, at least one data point prior to Tmax and three data points post-Tmax at the designated time points are needed; however, only two flexible post-dose PK concentration data points were available in this study. Although AUC∞ was not estimated in this study, the PK data collected in this study will be used in a population PK analysis in the future.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Plasma PK Parameters: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞), if Estimable
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
NA hour*nanograms per milliliter
Standard Deviation NA
NA signifies that the data was non-estimable and non-reliable.
|
SECONDARY outcome
Timeframe: From baseline (week 0) through Month 6Population: The MITT Population included all participants who received at least 1 dose of study intervention and have at least 1 post-baseline spot urinary oxalate to creatinine ratio. Here 'Number of participant analyzed' signifies 'Overall number of participants analyzed' and 'Number analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported percentage of participants from baseline to Month 6 Oxalate-to-creatinine Ratio less than and equal to (\<=) ULN or \<=1.5\*ULN at any time point through Month 6 in pediatric participants (birth to 11 years of age) with genetically confirmed PH1, PH2, or PH3 subgroups.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH1: <= 1.0 * ULN
|
62.5 Percentage of participants
|
66.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH1: <= 1.5 * ULN
|
100 Percentage of participants
|
100 Percentage of participants
|
88.9 Percentage of participants
|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH2: <= 1.0 * ULN
|
0 Percentage of participants
|
—
|
50.0 Percentage of participants
|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH2: <= 1.5 * ULN
|
100 Percentage of participants
|
—
|
75.0 Percentage of participants
|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH3: <= 1.0 * ULN
|
—
|
50.0 Percentage of participants
|
—
|
|
Percentage of Participants With Spot Urinary Oxalate-to-Creatinine Ratio <=Upper Limit of Normal (ULN) or <=1.5*ULN at Any Time Point Through Month 6 in PH1, PH2, or PH3 Participant Subgroups
PH3: <= 1.5 * ULN
|
—
|
100 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Month 6Population: MITT Population included all participants who received at least 1 dose of study intervention and have at least 1 post-baseline spot urinary oxalate to creatinine ratio. Here 'Number of participant analyzed' signifies 'Overall number of participants analyzed' and 'Number analyzed' signifies number of participants with available data for particular timepoint, for the respective arms.
This outcome measure reported Change from Baseline in GFR estimated Cystatin C at Month 6 (only in participants \>=12 Months of age at Screening) in PH1, PH2, or PH3 participant subgroups. The eGFR was calculated using multivariate Schwartz equation using formula: eGFR=39.8\*\[ht/Scr\]\^0.456 \[1.8/cysC\]\^0.418 \[30/BUN\]\^0.0791.076\^male\[ht/1.4\]\^0.179 where ht (height) = meters, Scr (serum creatinine) = milligrams per deciliter (mg/dL), cysC (cystatin C) = mg/L, and BUN (blood urea nitrogen) = mg/dL.
Outcome measures
| Measure |
Children 6 to 11 Years
n=9 Participants
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 0 to <2 Years
n=5 Participants
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=12 Participants
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|
|
Change From Baseline in eGFR at Month 6 (Only in Participants >=12 Months of Age at Screening) in PH1, PH2, or PH3 Participant Subgroups
PH1
|
-0.8 milliliters/minute/1.73m^2
Standard Deviation 7.21
|
0.0 milliliters/minute/1.73m^2
Standard Deviation 17.06
|
0.3 milliliters/minute/1.73m^2
Standard Deviation 10.2
|
|
Change From Baseline in eGFR at Month 6 (Only in Participants >=12 Months of Age at Screening) in PH1, PH2, or PH3 Participant Subgroups
PH2
|
-7.0 milliliters/minute/1.73m^2
Standard Deviation 0
|
—
|
3.5 milliliters/minute/1.73m^2
Standard Deviation 13.48
|
|
Change From Baseline in eGFR at Month 6 (Only in Participants >=12 Months of Age at Screening) in PH1, PH2, or PH3 Participant Subgroups
PH3
|
—
|
15.0 milliliters/minute/1.73m^2
Standard Deviation 9.90
|
—
|
Adverse Events
Children 0 to <2 Years
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Children 2 to <6 Years
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Children 6 to 11 Years
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Overall
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Children 0 to <2 Years
n=5 participants at risk
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 participants at risk
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 6 to 11 Years
n=9 participants at risk
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Overall
n=27 participants at risk
All participants that included children (0 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Children 0 to <2 Years
n=5 participants at risk
All participants that included neonates (0 to less than \[\<\] 2 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 milligrams per kilogram \[mg/kg\], not to exceed 170 milligrams \[mg\]), subcutaneously from Day 1 through Month 6.
|
Children 2 to <6 Years
n=13 participants at risk
All participants that included infants (2 to \<6 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Children 6 to 11 Years
n=9 participants at risk
All participants that included children (6 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
Overall
n=27 participants at risk
All participants that included children (0 to 11 years) with PH and relatively intact renal function based upon eGFR and serum creatinine, received monthly dose of nedosiran (3.5 mg/kg, not to exceed 170 mg), subcutaneously from Day 1 through Month 6.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 6 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 6 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
30.8%
4/13 • Number of events 5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Number of events 5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Investigations
Cystatin C increased
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Number of events 5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Impetigo
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
40.0%
2/5 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
18.5%
5/27 • Number of events 6 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
40.0%
2/5 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Number of events 8 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
40.0%
2/5 • Number of events 6 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 7 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
80.0%
4/5 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Number of events 9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
15.4%
2/13 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Tic
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
23.1%
3/13 • Number of events 8 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 8 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Investigations
Urinary sediment
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 4 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/5 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
20.0%
1/5 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/13 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline (Week 0) to Month 6
AE: Any untoward medical occurrence in participant, temporally associated with use of study drug, whether or not considered related to study drug. TEAE: Any AE if they have an onset or worsen in severity after a participant receives the study. Safety population: All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER