Trial Outcomes & Findings for Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD) (NCT NCT00701805)

NCT ID: NCT00701805

Last Updated: 2011-04-19

Results Overview

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 107 participants
• Primary outcome timeframe: Anytime during the study through Week 53
• Results posted on: 2011-04-19

Participant Flow

A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.

One of the 107 subjects withdrew consent before receiving study drug in this study. 106 subjects were treated with study drug. Two of these subjects were not included in the Full Analysis Set for analysis of efficacy because of subject death (n = 1) and withdrawal of consent (n = 1).

Participant milestones

Measure	Paricalcitol 2 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Overall Study STARTED	26	29	23	26
Overall Study COMPLETED	23	25	16	22
Overall Study NOT COMPLETED	3	4	7	4

Reasons for withdrawal

Measure	Paricalcitol 2 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Overall Study Withdrawal by Subject	3	1	4	3
Overall Study Adverse Event	0	1	1	0
Overall Study Missed 7 consecutive doses	0	1	0	0
Overall Study Admitted to hospital for 2 weeks	0	0	1	0
Overall Study Physician decision, change of therapy	0	0	0	1
Overall Study Difficult to travel to dialysis site	0	0	1	0
Overall Study Resumption criteria were not met	0	1	0	0

Baseline Characteristics

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Baseline characteristics by cohort

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	16 Participants n=4 Participants	63 Participants n=21 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	41 Participants n=21 Participants
Age Continuous	62.4 years STANDARD_DEVIATION 11.89 • n=5 Participants	60.3 years STANDARD_DEVIATION 12.06 • n=7 Participants	58.6 years STANDARD_DEVIATION 12.14 • n=5 Participants	61.1 years STANDARD_DEVIATION 11.91 • n=4 Participants	60.6 years STANDARD_DEVIATION 11.90 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	44 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment Japan	26 participants n=5 Participants	29 participants n=7 Participants	23 participants n=5 Participants	26 participants n=4 Participants	104 participants n=21 Participants

PRIMARY outcome

Timeframe: Anytime during the study through Week 53

Population: All subjects who received at least 1 dose of paricalcitol in this study.

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=27 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=30 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants With of Hypercalcemia	40.74 Percentage of participants	63.33 Percentage of participants	60.87 Percentage of participants	65.38 Percentage of participants

PRIMARY outcome

Timeframe: Anytime during the study through Week 53

Population: All subjects who received at least 1 dose of paricalcitol in this study.

The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=27 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=30 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants With Hyperphosphatemia	40.74 Percentage of participants	36.67 Percentage of participants	26.09 Percentage of participants	38.46 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Mean Change in Intact Parathyroid Hormone (iPTH)	-263.7 picograms/milliliter (pg/mL) Interval -342.59 to -184.8	-223.3 picograms/milliliter (pg/mL) Interval -295.58 to -151.11	-248.3 picograms/milliliter (pg/mL) Interval -308.16 to -188.36	-173.3 picograms/milliliter (pg/mL) Interval -345.37 to -1.24

SECONDARY outcome

Timeframe: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit Subjects with iPTH <= 180 pg/mL	42.3 Percentage of participants	41.4 Percentage of participants	39.1 Percentage of participants	38.5 Percentage of participants
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit Subjects with decrease in iPTH >= 50%	57.7 Percentage of participants	51.7 Percentage of participants	56.5 Percentage of participants	57.7 Percentage of participants

SECONDARY outcome

Timeframe: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%	100.0 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	96.2 Percentage of Participants

SECONDARY outcome

Timeframe: Every week from Baseline through Week 13 and every other week thereafter until Week 53

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Change in Mean iPTH Baseline	517.7 pg/mL Standard Deviation 208.90	502.5 pg/mL Standard Deviation 158.02	510.9 pg/mL Standard Deviation 110.73	519.7 pg/mL Standard Deviation 191.00
Change in Mean iPTH Week 1	543.5 pg/mL Standard Deviation 227.63	548.2 pg/mL Standard Deviation 186.89	527.7 pg/mL Standard Deviation 126.04	623.2 pg/mL Standard Deviation 250.76
Change in Mean iPTH Week 2	472.5 pg/mL Standard Deviation 214.50	478.8 pg/mL Standard Deviation 189.24	408.0 pg/mL Standard Deviation 120.17	490.3 pg/mL Standard Deviation 254.65
Change in Mean iPTH Week 3	463.4 pg/mL Standard Deviation 219.02	451.8 pg/mL Standard Deviation 198.15	337.0 pg/mL Standard Deviation 130.90	381.3 pg/mL Standard Deviation 233.11
Change in Mean iPTH Week 4	363.7 pg/mL Standard Deviation 226.01	378.9 pg/mL Standard Deviation 228.00	286.8 pg/mL Standard Deviation 123.40	291.7 pg/mL Standard Deviation 237.20
Change in Mean iPTH Week 5	356.6 pg/mL Standard Deviation 250.28	312.4 pg/mL Standard Deviation 204.53	251.6 pg/mL Standard Deviation 97.55	236.0 pg/mL Standard Deviation 192.90
Change in Mean iPTH Week 6	292.4 pg/mL Standard Deviation 246.21	244.7 pg/mL Standard Deviation 183.57	222.6 pg/mL Standard Deviation 109.80	228.8 pg/mL Standard Deviation 194.85
Change in Mean iPTH Week 7	255.0 pg/mL Standard Deviation 213.14	200.4 pg/mL Standard Deviation 157.93	198.1 pg/mL Standard Deviation 110.03	242.2 pg/mL Standard Deviation 172.47
Change in Mean iPTH Week 8	241.5 pg/mL Standard Deviation 213.32	185.3 pg/mL Standard Deviation 145.92	200.0 pg/mL Standard Deviation 89.35	242.5 pg/mL Standard Deviation 152.77
Change in Mean iPTH Week 9	245.1 pg/mL Standard Deviation 226.00	193.0 pg/mL Standard Deviation 139.02	203.7 pg/mL Standard Deviation 99.57	291.5 pg/mL Standard Deviation 225.08
Change in Mean iPTH Week 10	232.3 pg/mL Standard Deviation 192.04	219.7 pg/mL Standard Deviation 155.85	231.6 pg/mL Standard Deviation 136.57	247.5 pg/mL Standard Deviation 238.10
Change in Mean iPTH Week 11	253.6 pg/mL Standard Deviation 160.57	251.8 pg/mL Standard Deviation 170.12	246.2 pg/mL Standard Deviation 146.08	240.8 pg/mL Standard Deviation 216.55
Change in Mean iPTH Week 12	237.7 pg/mL Standard Deviation 161.57	267.1 pg/mL Standard Deviation 200.43	277.3 pg/mL Standard Deviation 192.73	266.2 pg/mL Standard Deviation 193.01
Change in Mean iPTH Week 13	268.6 pg/mL Standard Deviation 205.67	282.6 pg/mL Standard Deviation 192.29	312.4 pg/mL Standard Deviation 205.30	329.1 pg/mL Standard Deviation 236.15
Change in Mean iPTH Week 15	264.2 pg/mL Standard Deviation 165.97	317.3 pg/mL Standard Deviation 193.50	359.4 pg/mL Standard Deviation 198.28	357.4 pg/mL Standard Deviation 243.67
Change in Mean iPTH Week 17	260.3 pg/mL Standard Deviation 150.59	345.2 pg/mL Standard Deviation 242.46	338.2 pg/mL Standard Deviation 172.23	368.9 pg/mL Standard Deviation 290.14
Change in Mean iPTH Week 19	235.3 pg/mL Standard Deviation 153.17	314.9 pg/mL Standard Deviation 209.30	332.9 pg/mL Standard Deviation 169.80	357.0 pg/mL Standard Deviation 297.39
Change in Mean iPTH Week 21	226.4 pg/mL Standard Deviation 133.54	301.0 pg/mL Standard Deviation 188.52	314.0 pg/mL Standard Deviation 100.02	307.8 pg/mL Standard Deviation 233.98
Change in Mean iPTH Week 23	238.5 pg/mL Standard Deviation 190.65	309.3 pg/mL Standard Deviation 212.15	315.4 pg/mL Standard Deviation 106.45	323.7 pg/mL Standard Deviation 207.68
Change in Mean iPTH Week 25	207.1 pg/mL Standard Deviation 159.00	298.7 pg/mL Standard Deviation 207.91	307.9 pg/mL Standard Deviation 137.16	349.4 pg/mL Standard Deviation 246.98
Change in Mean iPTH Week 27	233.8 pg/mL Standard Deviation 154.92	293.6 pg/mL Standard Deviation 193.28	271.7 pg/mL Standard Deviation 117.34	349.3 pg/mL Standard Deviation 277.43
Change in Mean iPTH Week 29	233.4 pg/mL Standard Deviation 169.07	267.7 pg/mL Standard Deviation 173.87	270.9 pg/mL Standard Deviation 161.03	306.4 pg/mL Standard Deviation 217.70
Change in Mean iPTH Week 31	241.3 pg/mL Standard Deviation 148.54	287.9 pg/mL Standard Deviation 151.70	257.1 pg/mL Standard Deviation 132.29	285.7 pg/mL Standard Deviation 209.17
Change in Mean iPTH Week 33	238.8 pg/mL Standard Deviation 151.08	293.9 pg/mL Standard Deviation 175.41	263.2 pg/mL Standard Deviation 122.00	319.7 pg/mL Standard Deviation 285.10
Change in Mean iPTH Week 35	242.4 pg/mL Standard Deviation 154.48	290.7 pg/mL Standard Deviation 150.82	227.3 pg/mL Standard Deviation 109.73	336.0 pg/mL Standard Deviation 231.41
Change in Mean iPTH Week 37	277.7 pg/mL Standard Deviation 155.17	294.7 pg/mL Standard Deviation 176.56	267.6 pg/mL Standard Deviation 144.44	299.8 pg/mL Standard Deviation 241.77
Change in Mean iPTH Week 39	275.5 pg/mL Standard Deviation 156.20	316.0 pg/mL Standard Deviation 218.05	236.9 pg/mL Standard Deviation 124.05	296.7 pg/mL Standard Deviation 298.52
Change in Mean iPTH Week 41	224.0 pg/mL Standard Deviation 119.93	304.6 pg/mL Standard Deviation 163.90	239.1 pg/mL Standard Deviation 108.72	242.4 pg/mL Standard Deviation 115.27
Change in Mean iPTH Week 43	249.8 pg/mL Standard Deviation 145.48	319.4 pg/mL Standard Deviation 188.02	277.9 pg/mL Standard Deviation 117.03	246.2 pg/mL Standard Deviation 105.05
Change in Mean iPTH Week 45	247.7 pg/mL Standard Deviation 148.75	279.4 pg/mL Standard Deviation 171.65	251.5 pg/mL Standard Deviation 88.42	204.3 pg/mL Standard Deviation 96.70
Change in Mean iPTH Week 47	250.2 pg/mL Standard Deviation 162.72	272.0 pg/mL Standard Deviation 160.91	204.2 pg/mL Standard Deviation 70.13	240.2 pg/mL Standard Deviation 162.50
Change in Mean iPTH Week 49	271.0 pg/mL Standard Deviation 183.26	277.7 pg/mL Standard Deviation 212.64	221.3 pg/mL Standard Deviation 102.75	294.5 pg/mL Standard Deviation 213.57
Change in Mean iPTH Week 51	278.0 pg/mL Standard Deviation 180.69	295.0 pg/mL Standard Deviation 214.96	267.5 pg/mL Standard Deviation 165.72	283.0 pg/mL Standard Deviation 212.41
Change in Mean iPTH Week 53	258.6 pg/mL Standard Deviation 173.45	254.8 pg/mL Standard Deviation 143.86	252.7 pg/mL Standard Deviation 163.02	281.4 pg/mL Standard Deviation 221.18

SECONDARY outcome

Timeframe: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Duration of 2 Consecutive Decreases in iPTH >= 50%	60.6 days Standard Deviation 94.13	38.8 days Standard Deviation 34.51	47.2 days Standard Deviation 62.98	30.2 days Standard Deviation 32.52

SECONDARY outcome

Timeframe: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=29 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Duration of 2 Consecutive iPTH Values <= 180 pg/mL	35.1 days Standard Deviation 50.58	29.2 days Standard Deviation 20.15	28.2 days Standard Deviation 24.35	20.7 days Standard Deviation 33.43

SECONDARY outcome

Timeframe: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=3 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=4 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=4 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=7 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit	66.7 Percentage of participants	50.0 Percentage of participants	50.0 Percentage of participants	42.9 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Population: All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=10 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=10 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=4 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=11 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit	50.0 Percentage of participants	80.0 Percentage of participants	50.0 Percentage of participants	72.7 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Anytime from Week 13 through Week 53

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)

Outcome measures

Measure	Paricalcitol 2 µg ± 1 µg n=27 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=30 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 Participants Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
The Percentage of Participants With Hypercalcemia	22.22 Percentage of participants	43.30 Percentage of participants	30.43 Percentage of participants	46.15 Percentage of participants

Adverse Events

Paricalcitol 2 µg ± 1 µg

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

Paricalcitol 2 µg ± 2 µg

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Paricalcitol 4 µg ± 1 µg

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Paricalcitol 4 µg ± 2 µg

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol 2 µg ± 1 µg n=27 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=30 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Injury, poisoning and procedural complications Shunt stenosis	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Myocardial infarction	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Pneumonia	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Shunt occlusion	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Vascular disorders Arteriosclerosis obliterans	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Angina pectoris	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Cardiac failure	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Cardiac failure acute	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Supraventricular tachycardia	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Ear and labyrinth disorders Vertigo	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Colonic polyp	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Duodenal ulcer	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Oesophageal ulcer	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Sudden death	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Nasopharyngitis	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Shunt infection	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Contusion	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Shunt aneurysm	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Metabolism and nutrition disorders Fluid overload	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Spondylolithesis	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Cerebellar infarction	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Cerebral haemorrhage	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Cerebral infarction	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Transient ischaemic attack	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Renal and urinary disorders Renal haemorrhage	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Vascular disorders Hypotension	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Vascular disorders Shock	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.

Other adverse events

Measure	Paricalcitol 2 µg ± 1 µg n=27 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 2 µg ± 2 µg n=30 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 1 µg n=23 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.	Paricalcitol 4 µg ± 2 µg n=26 participants at risk Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Blood and lymphatic system disorders Nephrogenic anaemia	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Angina pectoris	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Cardiac disorders Palpitations	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Ear and labyrinth disorders Vertigo	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Eye disorders Cataract	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Eye disorders Conjunctival haemorrhage	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Eye disorders Conjunctivitis	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Eye disorders Ocular hyperaemia	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Abdominal pain upper	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Cheilitis	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Constipation	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	16.7% 5/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	34.8% 8/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	15.4% 4/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Dental caries	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Diarrhoea	22.2% 6/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	20.0% 6/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	26.1% 6/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	19.2% 5/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Dyspepsia	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Enterocolitis	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Gastritis	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Nausea	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Stomach discomfort	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Stomatitis	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Toothache	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Gastrointestinal disorders Vomiting	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.0% 3/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Feeling abnormal	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Malaise	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Oedema peripheral	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Pain	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Puncture site haemorrhage	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Puncture site pain	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Pyrexia	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
General disorders Vessel puncture site pain	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Immune system disorders Seasonal allergy	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Cystitis	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Gastroenteritis	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Herpes simplex	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Nasopharyngitis	74.1% 20/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	66.7% 20/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	65.2% 15/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	57.7% 15/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Oral herpes	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Pharyngitis	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Infections and infestations Upper respiratory tract infection	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Contusion	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	17.4% 4/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	30.8% 8/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Excoriation	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Fall	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	15.4% 4/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Joint sprain	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Procedural hypotension	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	19.2% 5/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Shunt occlusion	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Shunt stenosis	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Thermal burn	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Injury, poisoning and procedural complications Wound	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Investigations Bleeding time prolonged	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Investigations Blood alkaline phosphatase increased	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Investigations Blood pressure decreased	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Investigations Eosinophil percentage increased	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Metabolism and nutrition disorders Hypercalcaemia	55.6% 15/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	76.7% 23/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	73.9% 17/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	84.6% 22/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Metabolism and nutrition disorders Hyperkalaemia	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	20.0% 6/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Metabolism and nutrition disorders Hyperphosphataemia	55.6% 15/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	73.3% 22/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	52.2% 12/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	61.5% 16/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Arthralgia	25.9% 7/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	15.4% 4/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Back pain	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	15.4% 4/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	16.7% 5/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Myalgia	18.5% 5/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Dizziness	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Headache	18.5% 5/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	17.4% 4/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	15.4% 4/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Hypoaesthesia	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Nervous system disorders Restless legs syndrome	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Psychiatric disorders Insomnia	14.8% 4/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.7% 1/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Erythema	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	18.5% 5/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	13.3% 4/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	11.5% 3/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	6.7% 2/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Ingrowing nail	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Pruritus	22.2% 6/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	10.0% 3/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	17.4% 4/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	19.2% 5/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Pruritus generalised	7.4% 2/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Rash	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	4.3% 1/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.8% 1/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	3.3% 1/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	7.7% 2/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Vascular disorders Haemorrhage	0.00% 0/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	8.7% 2/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.
Vascular disorders Hypertension	11.1% 3/27 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	36.7% 11/30 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	0.00% 0/23 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.	19.2% 5/26 • All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form. Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.

Additional Information

Global Medical Services

Abbott

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