Trial Outcomes & Findings for ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis (NCT NCT00379899)
NCT ID: NCT00379899
Last Updated: 2014-07-23
Results Overview
Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
360 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2014-07-23
Participant Flow
Participants were enrolled from 27 October 2006 through 2 May 2008
Participant milestones
| Measure |
Cinacalcet
Cinacalcet plus low dose vitamin D
|
Control
Flexible vitamin D dosing
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
|
Overall Study
COMPLETED
|
140
|
140
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
Reasons for withdrawal
| Measure |
Cinacalcet
Cinacalcet plus low dose vitamin D
|
Control
Flexible vitamin D dosing
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Death
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Physician Decision
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Ineligibility determined
|
0
|
1
|
|
Overall Study
Noncompliance
|
1
|
1
|
|
Overall Study
Parathyroidectomy
|
0
|
2
|
|
Overall Study
Renal transplantation
|
5
|
4
|
|
Overall Study
Coronary artery bypass graft
|
1
|
1
|
|
Overall Study
Other protocol-specified criteria
|
3
|
4
|
|
Overall Study
Other
|
3
|
1
|
Baseline Characteristics
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
Cinacalcet
n=180 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=180 Participants
Flexible vitamin D dosing
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 Years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
61.8 Years
STANDARD_DEVIATION 12.8 • n=107 Participants
|
61.5 Years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
116 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Coronary Artery Calcification Score Stratification Factor
≥30 to 399
|
67 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Coronary Artery Calcification Score Stratification Factor
≥400 to 999
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Coronary Artery Calcification Score Stratification Factor
≥1000
|
66 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Percent Change From Baseline in CAC Score
|
43.74 Units on a scale
Standard Error 7.40
|
57.39 Units on a scale
Standard Error 7.77
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Number of participants achieving \>15% progression of coronary artery calcification (CAC) at week 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Number of Participants Achieving > 15% Progression of CAC.
|
63 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Absolute change from baseline in intact Parathyroid Hormone (iPTH)
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Absolute Change in PTH
|
-132.86 pg/mL
Standard Error 29.46
|
-71.55 pg/mL
Standard Error 30.83
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to \>75,000, with 0 representing no calcification.
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Change From Baseline in AC Score
|
935.92 Units on a scale
Standard Error 233.81
|
1677.28 Units on a scale
Standard Error 385.39
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to \>10,000, with 0 representing no calcification.
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Change From Baseline of the Progression of AVC.
|
24.29 Units on a scale
Standard Error 24.19
|
55.96 Units on a scale
Standard Error 18.34
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Percent change from baseline in intact Parathyroid Hormone (iPTH)
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Percent Change in PTH
|
-18.18 Percentage
Standard Error 5.53
|
-3.88 Percentage
Standard Error 5.70
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Absolute change from baseline in serum calcium to weeks 44 through 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Absolute Change in Calcium
|
-0.51 mg/dL
Standard Error 0.07
|
0.17 mg/dL
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Percent change from baseline in corrected serum calcium to weeks 44 through 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Percent Change in Calcium
|
-5.24 Percentage
Standard Error 0.72
|
1.98 Percentage
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Absolute change from baseline in serum phosphorus to weeks 44 through 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Absolute Change in Phosphorus
|
-0.92 mg/dL
Standard Error 0.18
|
-0.24 mg/dL
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Percent change from baseline in serum phosphorus to weeks 44 through 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Percent Change in Phosphorus
|
-9.63 Percentage
Standard Error 2.93
|
5.26 Percentage
Standard Error 5.48
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Absolute Change in Ca x P
|
-11.22 (mg/dL)2
Standard Error 1.68
|
-1.32 (mg/dL)2
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Baseline and Weeks 44 through 52Population: Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
Outcome measures
| Measure |
Cinacalcet
n=115 Participants
Cinacalcet plus low dose vitamin D
|
Control
n=120 Participants
Flexible vitamin D dosing
|
|---|---|---|
|
Percent Change in Ca x P
|
-14.56 Percentage
Standard Error 2.88
|
6.54 Percentage
Standard Error 5.15
|
Adverse Events
Cinacalcet
Serious events: 88 serious events
Other events: 95 other events
Deaths: 0 deaths
Control Group
Serious events: 82 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cinacalcet
n=180 participants at risk
|
Control Group
n=180 participants at risk
|
|---|---|---|
|
Infections and infestations
Bone abscess
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchiectasis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
7/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina pectoris
|
3.9%
7/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure acute
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter sepsis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Congenital, familial and genetic disorders
Familial mediterranean fever
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye pain
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Glaucoma
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter related complication
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter thrombosis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Drug intolerance
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Multi-organ failure
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Kidney transplant rejection
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abdominal abscess
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abdominal wall abscess
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abscess
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abscess limb
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abscess neck
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacterial sepsis
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Central line infection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Endocarditis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Enterococcal sepsis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gangrene
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Graft infection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lobar pneumonia
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Localised infection
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Peritoneal candidiasis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Peritonitis bacterial
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.9%
7/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Scrotal abscess
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urosepsis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood glucose increased
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dementia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Disturbance in attention
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypertonia
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Myoclonus
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Sciatica
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Spinal cord compression
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Arteriovenous graft
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Renal transplant
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Aortic aneurysm
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Embolism
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Extremity necrosis
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haematoma
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
2.2%
4/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Malignant hypertension
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
2/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral vascular disorder
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Shock
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Cinacalcet
n=180 participants at risk
|
Control Group
n=180 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.2%
13/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
11/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.1%
29/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.2%
22/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
29/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.8%
14/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
23/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.2%
22/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
10/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
6.1%
11/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.2%
13/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
7/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
12/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
3/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
10/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.8%
14/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.56%
1/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.9%
16/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
11/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
7/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.2%
22/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
5.6%
10/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.2%
13/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
7.2%
13/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.7%
21/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
18/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.8%
23/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
9/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.4%
17/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
6/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
10/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
7.8%
14/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.8%
5/180 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of 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 after completion. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER