Trial Outcomes & Findings for 20070360 Incident Dialysis (NCT NCT00803712)
NCT ID: NCT00803712
Last Updated: 2018-10-17
Results Overview
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
313 participants
Primary outcome timeframe
Weeks 22-26
Results posted on
2018-10-17
Participant Flow
First participant was enrolled on 19 February 2009 and last participant completed the study on 5 July 2011. 313 participants were enrolled from 82 study centers in US, Europe, Canada, Australia and Russia.
Once participants were determined to be eligible for the study, they entered a pre-randomization wash-out phase of 4 weeks (if receiving vitamin D at the time of enrollment). Four enrolled participants did not complete the pre-randomization wash-out phase and were not randomized into the study.
Participant milestones
| Measure |
Cinacalcet
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
155
|
|
Overall Study
Full Analysis Set
|
153
|
151
|
|
Overall Study
Safety Analysis Set
|
155
|
154
|
|
Overall Study
COMPLETED
|
118
|
128
|
|
Overall Study
NOT COMPLETED
|
36
|
27
|
Reasons for withdrawal
| Measure |
Cinacalcet
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Overall Study
Noncompliance
|
3
|
0
|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Death
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
"Other" in electronic Case Report Form
|
0
|
1
|
|
Overall Study
Protocol criteria (other)
|
0
|
2
|
|
Overall Study
Protocol criteria (renal transplant)
|
12
|
8
|
|
Overall Study
Administrative decision
|
2
|
3
|
|
Overall Study
Protocol criteria (parathyroidectomy)
|
1
|
1
|
Baseline Characteristics
20070360 Incident Dialysis
Baseline characteristics by cohort
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
57.0 years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
57.4 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
|
Age, Customized
Between 18 and 65 years
|
105 participants
n=99 Participants
|
99 participants
n=107 Participants
|
204 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
48 participants
n=99 Participants
|
52 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
120 participants
n=99 Participants
|
111 participants
n=107 Participants
|
231 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 participants
n=99 Participants
|
31 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Active Vitamin D Use
Active Vitamin D use
|
74 participants
n=99 Participants
|
72 participants
n=107 Participants
|
146 participants
n=206 Participants
|
|
Active Vitamin D Use
No active Vitamin D use
|
79 participants
n=99 Participants
|
79 participants
n=107 Participants
|
158 participants
n=206 Participants
|
|
iPTH
|
559.2 pg/mL
STANDARD_DEVIATION 338.2 • n=99 Participants
|
511.6 pg/mL
STANDARD_DEVIATION 253.6 • n=107 Participants
|
535.5 pg/mL
STANDARD_DEVIATION 299.6 • n=206 Participants
|
|
Corrected Serum Calcium
|
9.30 mg/dL
STANDARD_DEVIATION 0.69 • n=99 Participants
|
9.14 mg/dL
STANDARD_DEVIATION 0.49 • n=107 Participants
|
9.22 mg/dL
STANDARD_DEVIATION 0.60 • n=206 Participants
|
|
Serum Phosphorus
|
5.55 mg/dL
STANDARD_DEVIATION 1.70 • n=99 Participants
|
5.49 mg/dL
STANDARD_DEVIATION 1.60 • n=107 Participants
|
5.52 mg/dL
STANDARD_DEVIATION 1.65 • n=206 Participants
|
|
Albumin
|
3.93 g/dL
STANDARD_DEVIATION 0.39 • n=99 Participants
|
3.89 g/dL
STANDARD_DEVIATION 0.40 • n=107 Participants
|
3.91 g/dL
STANDARD_DEVIATION 0.39 • n=206 Participants
|
|
Dialysis Vintage
|
7.29 months
STANDARD_DEVIATION 2.54 • n=99 Participants
|
7.02 months
STANDARD_DEVIATION 2.78 • n=107 Participants
|
7.16 months
STANDARD_DEVIATION 2.66 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Responders defined as >= 30% reduction in Mean PTH
|
96 participants
|
58 participants
|
|
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Non responders
|
57 participants
|
93 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Responders defined as a mean PTH <= 300 pg/mL
|
87 participants
|
53 participants
|
|
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Non responders
|
66 participants
|
98 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Responders defined as >= 30% reduction in mean PTH
|
97 participants
|
72 participants
|
|
Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Non responders
|
56 participants
|
79 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Responders defined as a mean PTH <= 300 pg/mL
|
80 participants
|
67 participants
|
|
Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Non responders
|
73 participants
|
84 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Responders, a mean corrected calcium < 10.2 mg/dL
|
151 participants
|
144 participants
|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Non responders
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Responders, a mean corrected calcium < 10.2 mg/dL
|
146 participants
|
141 participants
|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Non responders
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26
All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Responders, a mean phosphorus < 5.5 mg/dL
|
100 participants
|
85 participants
|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
Non responders
|
53 participants
|
66 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52
All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Responders, a mean serum phosphorus < 5.5 mg/dL
|
81 participants
|
80 participants
|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
Non responders
|
72 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26 and Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Responders, a >= 30% reduction in mean iPTH
|
74 participants
|
42 participants
|
|
Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Non responders
|
79 participants
|
109 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26 and Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Responders, a mean iPTH <= 300 pg/mL
|
54 participants
|
39 participants
|
|
Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Non responders
|
99 participants
|
112 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26 and Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Responders, a mean corrected calcium < 10.2 mg/dL
|
145 participants
|
139 participants
|
|
Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Non responders
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26 and Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Responders, a mean serum phosphorus < 5.5 mg/dL
|
71 participants
|
64 participants
|
|
Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
Non responders
|
82 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
|
291.15 pg/mL
Interval 264.24 to 320.81
|
402.11 pg/mL
Interval 364.51 to 443.59
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
|
-34.62 percent change
Interval -41.32 to -27.93
|
-9.69 percent change
Interval -16.47 to -2.91
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
|
293.95 pg/mL
Interval 262.92 to 328.64
|
364.79 pg/mL
Interval 325.84 to 408.4
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
|
-34.15 percent change
Interval -41.96 to -26.33
|
-12.41 percent change
Interval -20.32 to -4.49
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
|
8.66 mg/dL
Interval 8.56 to 8.76
|
9.30 mg/dL
Interval 9.2 to 9.4
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
|
-5.68 percent change
Interval -6.73 to -4.63
|
1.05 percent change
Interval -0.01 to 2.12
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
|
8.95 mg/dL
Interval 8.85 to 9.06
|
9.42 mg/dL
Interval 9.32 to 9.53
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
|
-2.62 percent change
Interval -3.72 to -1.51
|
2.37 percent change
Interval 1.25 to 3.49
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
|
5.11 mg/dL
Interval 4.88 to 5.34
|
5.52 mg/dL
Interval 5.29 to 5.75
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
|
-1.79 percent change
Interval -6.51 to 2.93
|
3.94 percent change
Interval -0.87 to 8.75
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
|
5.37 mg/dL
Interval 5.12 to 5.62
|
5.53 mg/dL
Interval 5.27 to 5.78
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase
All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
Outcome measures
| Measure |
Cinacalcet
n=153 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=151 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
|
3.21 percent change
Interval -1.71 to 8.14
|
4.26 percent change
Interval -0.76 to 9.28
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=136 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=143 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
|
11 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Weeks 26-48Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=133 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=136 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hypercalcemia During the Maintenance Phase
|
16 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.
Hypercalcemia is defined as at least one corrected serum calcium value \>= 10.2 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=119 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=128 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
|
15 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Weeks 22-26Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=136 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=143 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
|
71 participants
|
93 participants
|
SECONDARY outcome
Timeframe: Weeks 26-48Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=133 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=138 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hyperphosphatemia During the Maintenance Phase
|
71 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Weeks 48-52Population: Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.
Hyperphosphatemia is defined as at least one serum phosphorus value \>= 5.5 mg/dL
Outcome measures
| Measure |
Cinacalcet
n=119 Participants
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=128 Participants
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
|
74 participants
|
83 participants
|
Adverse Events
Cinacalcet
Serious events: 72 serious events
Other events: 107 other events
Deaths: 0 deaths
Control Group
Serious events: 52 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cinacalcet
n=155 participants at risk
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=154 participants at risk
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Angina pectoris
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
4/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
2.6%
4/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Atrial tachycardia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
2.6%
4/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Pericarditis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Pericarditis uraemic
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Eye disorders
Diabetic retinopathy
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Eye disorders
Eye pain
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Eye disorders
Eyelid ptosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Eye disorders
Papilloedema
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Asthenia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Catheter site discharge
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Chest pain
|
1.9%
3/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Chills
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Death
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Hernia obstructive
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Inflammation
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Local swelling
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Nodule
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Oedema peripheral
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Pyrexia
|
1.9%
3/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Abscess
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Anal abscess
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Arthritis infective
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Bronchitis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Cellulitis
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Clostridial infection
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Device related infection
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Gangrene
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Groin infection
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Influenza
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Lobar pneumonia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Localised infection
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Osteomyelitis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Postoperative wound infection
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Sepsis
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Septic embolus
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Varicella
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
2.6%
4/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
4.5%
7/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.9%
3/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Investigations
Intraocular pressure increased
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
4/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Grand mal convulsion
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Hemianopia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Presyncope
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Syncope
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Psychiatric disorders
Disorientation
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Renal and urinary disorders
Azotaemia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Reproductive system and breast disorders
Priapism
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Hypertension
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
1.9%
3/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Hypotension
|
1.9%
3/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Steal syndrome
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Venous stenosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Venous thrombosis
|
0.65%
1/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.00%
0/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
Other adverse events
| Measure |
Cinacalcet
n=155 participants at risk
cinacalcet in combination with low-dose active vitamin D (if prescribed)
|
Control Group
n=154 participants at risk
Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
4/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
10/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
4.5%
7/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.1%
25/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
11.7%
18/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
30/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
9.7%
15/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
26/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
8.4%
13/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
General disorders
Pyrexia
|
5.2%
8/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
7.8%
12/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
9/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
3.2%
5/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
5.2%
8/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
9.1%
14/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
4.5%
7/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.2%
8/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
1.3%
2/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
8/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
3.2%
5/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.1%
25/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
0.65%
1/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
3/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.8%
9/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.7%
15/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
8.4%
13/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
4/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Nervous system disorders
Headache
|
5.2%
8/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
7.8%
12/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Psychiatric disorders
Insomnia
|
7.1%
11/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
10/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
6.5%
10/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.8%
9/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
5/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
6.5%
10/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Hypertension
|
6.5%
10/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
7.1%
11/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
|
Vascular disorders
Hypotension
|
3.9%
6/155 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
5.2%
8/154 • 56 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient randomized to the control group received cinacalcet throughout the study and is summarized in the cinacalcet arm for adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER