Trial Outcomes & Findings for Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis (NCT NCT00667576)
NCT ID: NCT00667576
Last Updated: 2012-01-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Baseline to Week 13 (Final Visit)
Results posted on
2012-01-20
Participant Flow
Participant milestones
| Measure |
Paricalcitol 2 µg ± 1 µg
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
31
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
29
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
Paricalcitol 2 µg ± 1 µg
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Missed Visit
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
87 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
66 Participants
n=10 Participants
|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 11.94 • n=93 Participants
|
60.7 years
STANDARD_DEVIATION 11.80 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 12.35 • n=27 Participants
|
61.5 years
STANDARD_DEVIATION 11.17 • n=483 Participants
|
64.1 years
STANDARD_DEVIATION 11.98 • n=36 Participants
|
61.3 years
STANDARD_DEVIATION 11.86 • n=10 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
64 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
89 Participants
n=10 Participants
|
|
Region of Enrollment
Japan
|
30 participants
n=93 Participants
|
31 participants
n=4 Participants
|
31 participants
n=27 Participants
|
31 participants
n=483 Participants
|
30 participants
n=36 Participants
|
153 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 13 (Final Visit)Population: The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=30 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
|
53.3 Percentage of participants
|
41.9 Percentage of participants
|
38.7 Percentage of participants
|
56.7 Percentage of participants
|
43.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 13 (Final Visit)Population: The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=30 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
|
-233.2 pg/mL
Interval -313.37 to -153.03
|
-260.8 pg/mL
Interval -366.64 to -154.9
|
-178.2 pg/mL
Interval -246.22 to -110.1
|
-211.7 pg/mL
Interval -309.14 to -114.33
|
-236.6 pg/mL
Interval -311.46 to -161.68
|
SECONDARY outcome
Timeframe: Baseline to Week 13 (Final Visit)Population: The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=30 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
|
36.7 Percentage of participants
|
32.3 Percentage of participants
|
32.3 Percentage of participants
|
36.7 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Through Week 13Population: The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=30 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
|
90.0 Percentage of participants
|
100 Percentage of participants
|
90.3 Percentage of participants
|
90.0 Percentage of participants
|
93.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Through Week 13Population: Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=27 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=28 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=27 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=28 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values
|
23.8 days
Standard Deviation 14.34
|
27.7 days
Standard Deviation 14.60
|
29.0 days
Standard Deviation 15.26
|
25.2 days
Standard Deviation 18.21
|
10.9 days
Standard Deviation 12.18
|
SECONDARY outcome
Timeframe: Through Week 13Population: Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=20 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=25 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=24 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=22 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=23 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL
|
22.0 days
Standard Deviation 12.23
|
26.1 days
Standard Deviation 15.36
|
19.7 days
Standard Deviation 13.32
|
17.2 days
Standard Deviation 15.52
|
3.1 days
Standard Deviation 3.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Week 13Population: Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.
Hypercalcemia was defined as at least 1 adjusted calcium value \> 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Hypercalcemia
|
30.0 Percentage of participants
|
48.4 Percentage of participants
|
45.2 Percentage of participants
|
58.1 Percentage of participants
|
30.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Week 13Population: Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.
Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL
Outcome measures
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=31 Participants
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 Participants
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Hyperphosphatemia
|
10.0 Percentage of participants
|
9.7 Percentage of participants
|
9.7 Percentage of participants
|
19.4 Percentage of participants
|
13.3 Percentage of participants
|
Adverse Events
Paricalcitol 2 µg ± 1 µg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Paricalcitol 2 µg ± 2 µg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Paricalcitol 4 µg ± 1 µg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Paricalcitol 4 µg ± 2 µg
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Maxacalcitol 5 or 10 µg ± 2.5 µg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 participants at risk
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 participants at risk
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 participants at risk
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=31 participants at risk
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 participants at risk
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Vascular disorders
iliac artery stenosis
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Vascular disorders
arteriosclerosis obliterans
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
shunt stenosis
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
shunt aneurysm
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Cardiac disorders
ventricular extrasystoles
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Nervous system disorders
cerebellar infarction
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
femoral neck fracture
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
General disorders
chest pain
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
Other adverse events
| Measure |
Paricalcitol 2 µg ± 1 µg
n=30 participants at risk
Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
|
Paricalcitol 2 µg ± 2 µg
n=31 participants at risk
Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
|
Paricalcitol 4 µg ± 1 µg
n=31 participants at risk
Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
|
Paricalcitol 4 µg ± 2 µg
n=31 participants at risk
Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
|
Maxacalcitol 5 or 10 µg ± 2.5 µg
n=30 participants at risk
Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Gastrointestinal disorders
cheilitis
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Gastrointestinal disorders
constipation
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
12.9%
4/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Gastrointestinal disorders
dental caries
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
3/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
9.7%
3/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Gastrointestinal disorders
epigastric discomfort
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
General disorders
puncture site haemorrhage
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Hepatobiliary disorders
hepatic function abnormal
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Infections and infestations
nasopharyngitis
|
30.0%
9/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
29.0%
9/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
32.3%
10/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
29.0%
9/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
30.0%
9/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Infections and infestations
pharyngitis
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Infections and infestations
upper respiratory tract infection
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
arthropod sting
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
13.3%
4/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
fall
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
10.0%
3/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
shunt occlusion
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Injury, poisoning and procedural complications
wound
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Investigations
blood pressure decreased
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
40.0%
12/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
61.3%
19/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
64.5%
20/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
74.2%
23/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
43.3%
13/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Metabolism and nutrition disorders
hyperphosphataemia
|
20.0%
6/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
32.3%
10/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
19.4%
6/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
38.7%
12/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
26.7%
8/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
10.0%
3/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
10.0%
3/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
10.0%
3/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Nervous system disorders
headache
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
9.7%
3/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
9.7%
3/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Nervous system disorders
restless leg syndrome
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract inflammation
|
6.7%
2/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
9.7%
3/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
13.3%
4/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
6.5%
2/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
0.00%
0/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
|
Vascular disorders
hypertension
|
3.3%
1/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
19.4%
6/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
3.2%
1/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
9.7%
3/31 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
13.3%
4/30 • Adverse events were collected after the first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks of treatment).
The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.
|
Additional Information
Global Medical Services
Abbott Japan Co., Ltd.
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER