Trial Outcomes & Findings for Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D (NCT NCT00977080)

Last Updated: 2012-06-20

Results Overview

iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

272 participants

Primary outcome timeframe

Weeks 21 to 28

Results posted on

2012-06-20

Participant Flow

Of the 272 participants enrolled in the study, 4 did not receive study drug and were not included in the population analyzed.

Participant milestones

Participant milestones
Measure	IV Paricalcitol in the IV Stratum IV stratum	Cinacalcet in the IV Stratum IV stratum	Oral Paricalcitol in the Oral Stratum Oral stratum	Cinacalcet in the Oral Stratum Oral stratum
Overall Study STARTED	62	64	72	70
Overall Study COMPLETED	50	44	56	53
Overall Study NOT COMPLETED	12	20	16	17

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Paricalcitol in the IV Stratum IV stratum	Cinacalcet in the IV Stratum IV stratum	Oral Paricalcitol in the Oral Stratum Oral stratum	Cinacalcet in the Oral Stratum Oral stratum
Overall Study Adverse Event	2	7	7	7
Overall Study Withdrawal by Subject	1	5	1	5
Overall Study Protocol Violation	7	3	4	3
Overall Study Noncompliance	0	2	1	0
Overall Study Calcium < 7.5 mg/dL on 3 draws	0	0	0	1
Overall Study Required kidney transplantation	1	3	3	1
Overall Study Travel for family reasons	1	0	0	0

Baseline Characteristics

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Paricalcitol in the IV Stratum n=62 Participants IV stratum	Cinacalcet in the IV Stratum n=64 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=72 Participants Oral stratum	Cinacalcet in the Oral Stratum n=70 Participants Oral stratum	Total n=268 Participants Total of all reporting groups
Age Continuous	61.2 years STANDARD_DEVIATION 12.71 • n=5 Participants	59.9 years STANDARD_DEVIATION 12.04 • n=7 Participants	65.7 years STANDARD_DEVIATION 13.48 • n=5 Participants	65.1 years STANDARD_DEVIATION 12.50 • n=4 Participants	63.1 years STANDARD_DEVIATION 12.89 • n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	23 Participants n=5 Participants	27 Participants n=4 Participants	100 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	38 Participants n=7 Participants	49 Participants n=5 Participants	43 Participants n=4 Participants	168 Participants n=21 Participants
History of type 1 diabetes mellitus Yes	6 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
History of type 1 diabetes mellitus No	56 Participants n=5 Participants	63 Participants n=7 Participants	71 Participants n=5 Participants	68 Participants n=4 Participants	258 Participants n=21 Participants
History of type 2 diabetes mellitus Yes	37 Participants n=5 Participants	34 Participants n=7 Participants	28 Participants n=5 Participants	9 Participants n=4 Participants	108 Participants n=21 Participants
History of type 2 diabetes mellitus No	25 Participants n=5 Participants	30 Participants n=7 Participants	44 Participants n=5 Participants	61 Participants n=4 Participants	160 Participants n=21 Participants
History of angina Yes	8 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	28 Participants n=21 Participants
History of angina No	54 Participants n=5 Participants	62 Participants n=7 Participants	61 Participants n=5 Participants	63 Participants n=4 Participants	240 Participants n=21 Participants
History of coronary artery disease Yes	25 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	6 Participants n=4 Participants	61 Participants n=21 Participants
History of coronary artery disease No	37 Participants n=5 Participants	45 Participants n=7 Participants	61 Participants n=5 Participants	64 Participants n=4 Participants	207 Participants n=21 Participants
History of left ventricular hypertrophy Yes	12 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	29 Participants n=21 Participants
History of left ventricular hypertrophy No	50 Participants n=5 Participants	60 Participants n=7 Participants	65 Participants n=5 Participants	64 Participants n=4 Participants	239 Participants n=21 Participants
History of myocardial infarction Yes	12 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	38 Participants n=21 Participants
History of myocardial infarction No	50 Participants n=5 Participants	56 Participants n=7 Participants	62 Participants n=5 Participants	62 Participants n=4 Participants	230 Participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=57 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).	30 Participants	16 Participants	31 Participants	23 Participants

SECONDARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28)

iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=57 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).	44 Participants	24 Participants	39 Participants	30 Participants

SECONDARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=57 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).	34 Participants	11 Participants	26 Participants	22 Participants

SECONDARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=57 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata	30 Participants	16 Participants	31 Participants	23 Participants

SECONDARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)

Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was \< 8.4 mg/dL were counted.

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=56 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)	0 Participants	23 Participants	2 Participants	29 Participants

SECONDARY outcome

Timeframe: Weeks 21 to 28

Population: Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)

Outcome measures

Outcome measures
Measure	IV Paricalcitol in the IV Stratum n=52 Participants IV stratum	Cinacalcet in the IV Stratum n=49 Participants IV stratum	Oral Paricalcitol in the Oral Stratum n=56 Participants Oral stratum	Cinacalcet in the Oral Stratum n=53 Participants Oral stratum
Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)	4 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

IV Paricalcitol in the IV Stratum

Serious events: 22 serious events

Other events: 48 other events

Deaths: 0 deaths

Cinacalcet in the IV Stratum

Serious events: 28 serious events

Other events: 46 other events

Deaths: 0 deaths

Oral Paricalcitol in the Oral Stratum

Serious events: 22 serious events

Other events: 59 other events

Deaths: 0 deaths

Cinacalcet in the Oral Stratum

Serious events: 15 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Serious adverse events
Measure	IV Paricalcitol in the IV Stratum n=62 participants at risk IV stratum	Cinacalcet in the IV Stratum n=64 participants at risk IV stratum	Oral Paricalcitol in the Oral Stratum n=72 participants at risk Oral stratum	Cinacalcet in the Oral Stratum n=70 participants at risk Oral stratum
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Perirenal haematoma	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Blood and lymphatic system disorders Haemolysis	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Acute myocardial infarction	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Angina pectoris	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Atril fibrillation	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Bradycardia	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Cardiac arrest	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Cardiac failure congestive	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Coronary artery disease	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Myocardial infarction	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Pericarditis	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Eye disorders Eye pain	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Asthenia	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Chest pain	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Device occlusion	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Malaise	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Medical device complication	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Non-cardiac chest pain	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Hepatobiliary disorders Cholecystitis	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Abdominal infection	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Bacteraemia	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Bronchitis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Cellulitis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Device related infection	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Endocarditis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Gangrene	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.

Other adverse events
Measure	IV Paricalcitol in the IV Stratum n=62 participants at risk IV stratum	Cinacalcet in the IV Stratum n=64 participants at risk IV stratum	Oral Paricalcitol in the Oral Stratum n=72 participants at risk Oral stratum	Cinacalcet in the Oral Stratum n=70 participants at risk Oral stratum
Blood and lymphatic system disorders Anaemia	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.6% 4/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal discomfort	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain	9.7% 6/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.2% 3/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.6% 4/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	6.2% 4/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.7% 4/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Diarhhoea	9.7% 6/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	7.8% 5/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	9.7% 7/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 3/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Diverticulum	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.2% 3/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	11.3% 7/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	12.5% 8/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.6% 4/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	10.0% 7/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	9.7% 6/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	9.4% 6/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	12.5% 9/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	7.1% 5/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Asthenia	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Chest pain	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.2% 3/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Fatigue	9.7% 6/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Oedema peripheral	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.7% 4/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Pain	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Pyrexia	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.6% 4/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.7% 4/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Arteriovenous fistula site infection	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Bronchitis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Cellulitis	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Cystitis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Influenza	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Nasopharyngitis	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	5.6% 4/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Pneumonia	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	7.1% 5/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Urinary tract infection	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	3.1% 2/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	6.5% 4/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.9% 2/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Contusion	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Fall	1.6% 1/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Vascular graft complication	4.8% 3/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.6% 1/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	4.7% 3/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	1.4% 1/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Wound	3.2% 2/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.
Investigations Blood calcium increased	0.00% 0/62 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/64 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	2.8% 2/72 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/70 • Treatment-emergent adverse events were reported. These include all adverse events that began on or after the first dose of study drug through 30 days after the last dose of study drug.