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Trial record 28 of 380 for:    FERRIC CATION

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01191255
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Hyperphosphatemia
Kidney Failure
Intervention Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
Enrollment 441
Recruitment Details  
Pre-assignment Details
  1. Only subjects that completed the SAP on KRX-0502 were eligible to be included in the EAP
  2. in the EAP, subjects received only Placebo or KRX-0502-EAP
  3. 3 Subjects switched from 'Active Control' to KRX-0502 during the SAP and were randomized into the EAP
  4. In the 'Active Control' group, a combination of phosphate binders was allowed
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period. Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Period Title: Safety Assessment Period
Started 149 [1] 292 0 0
Safety Population 149 289 0 0
Completed 111 193 0 0
Not Completed 38 99 0 0
[1]
3 subjects were assigned to receive KRX-0502 but didn't receive a single dose
Period Title: Efficacy Assessment Period
Started 0 0 96 96
Completed 0 0 70 90
Not Completed 0 0 26 6
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP Total
Hide Arm/Group Description Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period. Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period. Total of all reporting groups
Overall Number of Baseline Participants 146 281 91 91 609
Hide Baseline Analysis Population Description
Total number of subjects in the full analysis population in the SAP was 427. 182 subjects that were treated with KRX-0502 in the SAP were randomized 1:1 to receive either KRX-0502 or Placebo in the EAP.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 281 participants 91 participants 91 participants 609 participants
Age <65 years (SAP) 118 223 0 0 341
Age >= 65 years (SAP) 28 58 0 0 86
Age <65 years (EAP) 0 0 77 73 150
Age >= 65 years (EAP) 0 0 14 18 32
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 281 participants 91 participants 91 participants 609 participants
Female (SAP) 62 106 0 0 168
Male (SAP) 84 175 0 0 259
Female (EAP) 0 0 77 73 150
Male (EAP) 0 0 14 18 32
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 281 participants 91 participants 91 participants 609 participants
Hispanic or Latino (SAP) 23 41 0 0 64
Not Hispanic or Latino (SAP) 123 239 0 0 362
Unknown or not reported (SAP) 0 1 0 0 1
Hispanic or Latino (EAP) 0 0 14 9 23
Not Hispanic or Latino (EAP) 0 0 77 82 159
Unknown or not reported (EAP) 0 0 0 0 0
American Indian or Alaska Native (SAP) 1 2 0 0 3
Asian (SAP) 1 0 0 0 1
Native Hawaiian or Other Pacific Islander (SAP) 2 0 0 0 2
Black or African American (SAP) 77 153 0 0 230
White (SAP) 61 114 0 0 175
More Than One Race (SAP) 0 1 0 0 1
Unknown or Not Reported (SAP) 4 11 0 0 15
American Indian or Alaska Native (EAP) 0 0 1 0 1
Asian (EAP) 0 0 0 0 0
Native Hawaiian or Other Pacific Islander (EAP) 0 0 0 0 0
Black or African American (EAP) 0 0 48 59 107
White (EAP) 0 0 39 28 67
More Than One Race (EAP) 0 0 1 0 1
Unknown or Not Reported (EAP) 0 0 2 4 6
1.Primary Outcome
Title Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
Hide Description Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (LOCF)
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description:
Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Overall Number of Participants Analyzed 0 0 91 91
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (Week 52) 5.44  (1.459) 5.12  (1.189)
End of EAP (Week 56) 7.23  (1.784) 4.89  (1.291)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo-EAP, KRX-0502 (Ferric Citrate)-EAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Mean Serum Ferritin From Baseline to Week 52
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (LOCF)
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description:
Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Overall Number of Participants Analyzed 137 253 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 609.50  (307.689) 592.80  (292.863)
End of SAP (Week 52) 631.87  (368.919) 894.88  (481.788)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Control-SAP, KRX-0502 (Ferric Citrate)-SAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (LOCF)
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description:
Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Overall Number of Participants Analyzed 137 252 0 0
Mean (Standard Deviation)
Unit of Measure: % Saturation
Baseline 30.8  (11.57) 31.3  (11.21)
End of SAP (Week 52) 29.7  (11.43) 39.2  (16.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Control-SAP, KRX-0502 (Ferric Citrate)-SAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title IV Iron Analysis
Hide Description Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description:
Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Overall Number of Participants Analyzed 138 271 0 0
Median (Full Range)
Unit of Measure: mg/day
3.83
(0.0 to 43.6)
1.87
(0.0 to 24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Control-SAP, KRX-0502 (Ferric Citrate)-SAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title ESA Analysis
Hide Description Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Control-SAP KRX-0502 (Ferric Citrate)-SAP Placebo-EAP KRX-0502 (Ferric Citrate)-EAP
Hide Arm/Group Description:
Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.

Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.

Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.

Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Overall Number of Participants Analyzed 141 273 0 0
Median (Full Range)
Unit of Measure: Units/Day
993.46
(0.0 to 11015)
755.80
(0.0 to 8171.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Control-SAP, KRX-0502 (Ferric Citrate)-SAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Serious treatement emergent adverse events (TEAEs) up to 56 weeks
Adverse Event Reporting Description Safety Population, includes all patients that took at least 1 dose of study drug
 
Arm/Group Title KRX-0502 (SAP) Active Control (SAP) KRX-0502 (EAP) Placebo (EAP)
Hide Arm/Group Description Safety Assessment Period (Week 1-52) Safety Assessment Period (Week 1-52) Efficacy Assessment Period (Week 52-56) Efficacy Assessment Period (Week 52-56)
All-Cause Mortality
KRX-0502 (SAP) Active Control (SAP) KRX-0502 (EAP) Placebo (EAP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
KRX-0502 (SAP) Active Control (SAP) KRX-0502 (EAP) Placebo (EAP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/289 (39.45%)      73/149 (48.99%)      11/95 (11.58%)      17/95 (17.89%)    
Blood and lymphatic system disorders         
Anemia  1  4/289 (1.38%)  4 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Graft thrombosis  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Iron deficiency anemia  1  1/289 (0.35%)  1 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Sepsis  1  5/289 (1.73%)  5 8/149 (5.37%)  8 0/95 (0.00%)  0 1/95 (1.05%)  1
Disseminated Intravascular Coagulation  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Leukocytosis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Lymphadenopathy  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Thrombocytopenia  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardiac disorders         
Acute coronary syndrome  1  1/289 (0.35%)  1 2/149 (1.34%)  2 1/95 (1.05%)  1 0/95 (0.00%)  0
Acute myocardial infarction  1  1/289 (0.35%)  1 4/149 (2.68%)  4 0/95 (0.00%)  0 0/95 (0.00%)  0
Aortic stenosis  1  0/289 (0.00%)  0 2/149 (1.34%)  2 1/95 (1.05%)  1 0/95 (0.00%)  0
Atrial fibrillation  1  4/289 (1.38%)  4 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardiac arrest  1  3/289 (1.04%)  3 2/149 (1.34%)  2 1/95 (1.05%)  1 0/95 (0.00%)  0
Cardiac failure congestive  1  1/289 (0.35%)  1 3/149 (2.01%)  3 0/95 (0.00%)  0 0/95 (0.00%)  0
Chest discomfort  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Chest pain  1  8/289 (2.77%)  8 5/149 (3.36%)  5 2/95 (2.11%)  2 1/95 (1.05%)  1
Coronary artery disease  1  1/289 (0.35%)  1 3/149 (2.01%)  3 1/95 (1.05%)  1 0/95 (0.00%)  0
Dyspnea  1  1/289 (0.35%)  1 3/149 (2.01%)  3 0/95 (0.00%)  0 0/95 (0.00%)  0
Hypertensive crisis  1  3/289 (1.04%)  3 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Hypertensive emergency  1  3/289 (1.04%)  3 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Myocardial infarction  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Orthostatic hypotension  1  3/289 (1.04%)  3 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Sudden death  1  2/289 (0.69%)  2 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Atrial Thrombosis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Diastolic Dysfunction  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Sinus Tachycardia  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Angina Pectoris  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Angina Unstable  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Arrhythmia  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardiac Failure  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardiac Failure Acute  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardiac Tamponade  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cardio-Respiratory Arrest  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pericardial Effusion  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Tachycardia  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Ventricular Fibrillation  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Endocarditis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
atrial flutter  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Mitral Valve Incompetence  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Vertigo Positional  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Eye disorders         
Retinopathy Hypertensive  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Gastrointestinal disorders         
Abdominal pain  1  4/289 (1.38%)  4 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Constipation  1  2/289 (0.69%)  2 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Diarrhea  1  2/289 (0.69%)  2 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastroenteritis  1  0/289 (0.00%)  0 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastrointestinal hemorrhage  1  5/289 (1.73%)  5 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Ileitis  1  0/289 (0.00%)  0 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Impaired gastric emptying  1  1/289 (0.35%)  1 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Nausea  1  3/289 (1.04%)  3 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Pancreatitis  1  2/289 (0.69%)  2 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Pancreatitis acute  1  0/289 (0.00%)  0 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Rectal hemorrhage  1  0/289 (0.00%)  0 3/149 (2.01%)  3 0/95 (0.00%)  0 0/95 (0.00%)  0
Vomiting  1  2/289 (0.69%)  2 4/149 (2.68%)  4 0/95 (0.00%)  0 0/95 (0.00%)  0
Colitis  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Duodenitis  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Small Intestinal Obstruction  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Abdominal Pain Upper  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Ascites  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastritis Erosive  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Haematemesis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Lower Gastrointestinal Haemorrhage  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Oesophagitis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Retroperitoneal Haematoma  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Swollen Tongue  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Upper Gastrointestinal Haemorrhage  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastroenteritis Viral  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastrointestinal Viral Infection  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
General disorders         
Asthenia  1  3/289 (1.04%)  3 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Fluid Overload  1  5/289 (1.73%)  5 5/149 (3.36%)  5 0/95 (0.00%)  0 0/95 (0.00%)  0
Hyperkalemia  1  4/289 (1.38%)  4 2/149 (1.34%)  2 0/95 (0.00%)  0 1/95 (1.05%)  1
Hypokalemia  1  3/289 (1.04%)  3 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Non-cardiac chest pain  1  0/289 (0.00%)  0 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Pyrexia  1  4/289 (1.38%)  4 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Adverse Event  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Device Occlusion  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Hernia Obstructive  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Oedema  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Acute Hepatic Failure  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cholecystitis Acute  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Cholelithiasis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Hepatic Cirrhosis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Immune system disorders         
Anaphylactic Reaction  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Infections and infestations         
Bacteremia  1  1/289 (0.35%)  1 3/149 (2.01%)  3 0/95 (0.00%)  0 2/95 (2.11%)  2
Cellulitis  1  1/289 (0.35%)  1 2/149 (1.34%)  2 0/95 (0.00%)  0 1/95 (1.05%)  1
Clostridium difficile colitis  1  0/289 (0.00%)  0 2/149 (1.34%)  2 0/95 (0.00%)  0 1/95 (1.05%)  1
Device related infection  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Gangrene  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Osteomyelitis  1  3/289 (1.04%)  3 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Peritonitis  1  2/289 (0.69%)  2 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Urinary tract infection  1  4/289 (1.38%)  4 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Wound infection  1  3/289 (1.04%)  3 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Lobar Pneumonia  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Staphylococcal Bacteraemia  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Staphylococcal Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Viral Infection  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Abscess  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Anal Abscess  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Appendicitis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Arteriovenous Graft Site Infection  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Breast Abscess  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Catheter Site Cellulitis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Catheter Site Infection  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Clostridial Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Diabetic Foot Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Diverticulitis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Enterococcal Sepsis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastroenteritis Viral  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Graft Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Localised Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Oesophageal Candidiasis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pelvic Abscess  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Postoperative Wound Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Tooth Abscess  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Viral Upper Respiratory Tract Infection  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Bronchitis  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Injury, poisoning and procedural complications         
Hip Fracture  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Vascular Graft Complication  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Arteriovenous Fistula Site Complication  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Arteriovenous Fistula Site Haemorrhage  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Fall  1  1/289 (0.35%)  1 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Fibula Fracture  1  0/289 (0.00%)  0 1/149 (0.67%)  1 1/95 (1.05%)  1 0/95 (0.00%)  0
Post Procedural Haematoma  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Post Procedural Haemorrhage  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Postoperative Wound Complication  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Procedural Hypertension  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Procedural Pain  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Spinal Compression Fracture  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Subdural Haematoma  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Tibia Fracture  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Vascular Graft Thrombosis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Wound  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Graft Infection  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Ankle Fracture  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Rib Fracture  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Investigations         
Alanine Aminotransferase Increased  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Aspartate Aminotransferase Increased  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Blood Glucose Decreased  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Catheterisation Cardiac  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Electrocardiogram Qt Prolonged  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Heart Rate Increased  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
International Normalised Ratio Increased  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Liver Function Test Abnormal  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Troponin I Increased  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Troponin Increased  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycemia  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Hyperglycaemia  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Decreased Appetite  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Diabetic Ketoacidosis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Back Pain  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Chondrocalcinosis Pyrophosphate  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Fistula  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Intervertebral Disc Degeneration  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Joint Effusion  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Joint Swelling  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Muscular Weakness  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 1/95 (1.05%)  1
Musculoskeletal Pain  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pain In Extremity  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Spinal Column Stenosis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Gallbladder Cancer Metastatic  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Metastatic Neoplasm  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Oesophageal Neoplasm  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Lymphoma  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Neoplasm Malignant  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Renal Cyst Infection  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Prostate Cancer  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Hepatobiliary Disorders  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Nervous system disorders         
Syncope  1  4/289 (1.38%)  4 2/149 (1.34%)  2 0/95 (0.00%)  0 0/95 (0.00%)  0
Transient ischemic attack  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cerebrovascular Accident  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 1/95 (1.05%)  1
Cerebral Haemorrhage  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Aphasia  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Brain Oedema  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Brain Stem Haemorrhage  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Cerebral Infarction  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Convulsion  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Encephalopathy  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Hemiparesis  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Ischaemic Cerebral Infarction  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Lumbar Radiculopathy  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Myoclonus  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Quadriplegia  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Hepatic Cancer Metastatic  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Haemorrhagic Stroke  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Loss of Consciousness  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Psychiatric Disorders  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Psychiatric disorders         
Confusional state  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0/95 (0.00%)  0
Mental disorder  1  3/289 (1.04%)  3 2/149 (1.34%)  2 1/95 (1.05%)  1 0/95 (0.00%)  0
Depression  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Anxiety  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Mental Status Changes  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Suicide Attempt  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Renal and urinary disorders         
Renal failure chronic  1  1/289 (0.35%)  1 2/149 (1.34%)  2 1/95 (1.05%)  1 0/95 (0.00%)  0
Renal Failure Acute  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Renal Mass  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Urethral Obstruction  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Reproductive system and breast disorders         
Vaginal Haemorrhage  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute pulmonary edema  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Cough  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Dyspnea  1  2/289 (0.69%)  2 4/149 (2.68%)  4 0/95 (0.00%)  0 0/95 (0.00%)  0
Hypoxia  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pleural effusion  1  3/289 (1.04%)  3 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Pneumonia  1  8/289 (2.77%)  8 4/149 (2.68%)  4 0/95 (0.00%)  0 1/95 (1.05%)  1
Pulmonary edema  1  2/289 (0.69%)  2 3/149 (2.01%)  3 0/95 (0.00%)  0 1/95 (1.05%)  1
Pulmonary embolism  1  2/289 (0.69%)  2 3/149 (2.01%)  3 0/95 (0.00%)  0 0/95 (0.00%)  0
Respiratory failure  1  3/289 (1.04%)  3 3/149 (2.01%)  3 0/95 (0.00%)  0 0/95 (0.00%)  0
Acute Respiratory Failure  1  1/289 (0.35%)  1 1/149 (0.67%)  1 0/95 (0.00%)  0 1/95 (1.05%)  1
Asthma  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Dyspnoea Exertional  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pulmonary Mass  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Respiratory Distress  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Pneumonia Aspiration  1  0/289 (0.00%)  0 0/149 (0.00%)  0 1/95 (1.05%)  1 0/95 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin ulcer  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Penile Ulceration  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Angioedema  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Surgical and medical procedures         
Arteriovenous graft  1  2/289 (0.69%)  2 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Leg amputation  1  2/289 (0.69%)  2 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Renal transplant  1  13/289 (4.50%)  13 5/149 (3.36%)  5 1/95 (1.05%)  1 0/95 (0.00%)  0
Arterial Bypass Operation  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Arteriovenous Fistula Operation  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Coronary Angioplasty  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Coronary Artery Bypass  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Debridement  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Pancreas Transplant  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Parathyroidectomy  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Renal And Pancreas Transplant  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Stent Placement  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Surgery  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Metabolism And Nutrition Disorders  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Vascular disorders         
Deep vein thrombosis  1  1/289 (0.35%)  1 3/149 (2.01%)  3 0/95 (0.00%)  0 1/95 (1.05%)  1
Hypertension  1  5/289 (1.73%)  5 5/149 (3.36%)  5 1/95 (1.05%)  1 1/95 (1.05%)  1
Hypotension  1  6/289 (2.08%)  6 4/149 (2.68%)  4 1/95 (1.05%)  1 0/95 (0.00%)  0
Vascular access complication  1  2/289 (0.69%)  2 3/149 (2.01%)  3 1/95 (1.05%)  1 0/95 (0.00%)  0
Arteriosclerosis  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Arteriovenous Fistula  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Haematoma  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Hypovolaemic Shock  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Ischaemia  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Malignant Hypertension  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Necrosis Ischaemic  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Peripheral Ischaemia  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Peripheral Vascular Disorder  1  1/289 (0.35%)  1 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Steal Syndrome  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Subclavian Artery Occlusion  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 1/95 (1.05%)  1
Septic Shock  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Dizziness  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Haemorrhoids  1  0/289 (0.00%)  0 1/149 (0.67%)  1 0/95 (0.00%)  0 0/95 (0.00%)  0
Haemorrhage  1  0/289 (0.00%)  0 0/149 (0.00%)  0 0/95 (0.00%)  0 1/95 (1.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KRX-0502 (SAP) Active Control (SAP) KRX-0502 (EAP) Placebo (EAP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   211/289 (73.01%)      88/149 (59.06%)      5/95 (5.26%)      0/95 (0.00%)    
Cardiac disorders         
Dyspnea  1  10/289 (3.46%)  10 11/149 (7.38%)  11 0/95 (0.00%)  0 0/95 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  14/289 (4.84%)  14 7/149 (4.70%)  7 0/95 (0.00%)  0 0/95 (0.00%)  0
Constipation  1  21/289 (7.27%)  21 6/149 (4.03%)  6 0/95 (0.00%)  0 0/95 (0.00%)  0
Diarrhea  1  72/289 (24.91%)  72 19/149 (12.75%)  19 0/95 (0.00%)  0 0/95 (0.00%)  0
Feces discolored  1  49/289 (16.96%)  49 0/149 (0.00%)  0 0/95 (0.00%)  0 0/95 (0.00%)  0
Nausea  1  38/289 (13.15%)  38 18/149 (12.08%)  18 0/95 (0.00%)  0 0/95 (0.00%)  0
Vomiting  1  24/289 (8.30%)  24 18/149 (12.08%)  18 0/95 (0.00%)  0 0/95 (0.00%)  0
General disorders         
Chest pain  1  15/289 (5.19%)  15 6/149 (4.03%)  6 0/95 (0.00%)  0 0/95 (0.00%)  0
Edema peripheral  1  9/289 (3.11%)  9 8/149 (5.37%)  8 0/95 (0.00%)  0 0/95 (0.00%)  0
Pyrexia  1  9/289 (3.11%)  9 7/149 (4.70%)  7 0/95 (0.00%)  0 0/95 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  21/289 (7.27%)  21 9/149 (6.04%)  9 0/95 (0.00%)  0 0/95 (0.00%)  0
Injury, poisoning and procedural complications         
Arteriovenous fistula site complication  1  12/289 (4.15%)  12 8/149 (5.37%)  8 0/95 (0.00%)  0 0/95 (0.00%)  0
Vascular access complication  1  23/289 (7.96%)  23 14/149 (9.40%)  14 5/95 (5.26%)  5 0/95 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  15/289 (5.19%)  15 5/149 (3.36%)  5 0/95 (0.00%)  0 0/95 (0.00%)  0
Hyperkalemia  1  8/289 (2.77%)  8 9/149 (6.04%)  9 0/95 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  7/289 (2.42%)  7 7/149 (4.70%)  7 0/95 (0.00%)  0 0/95 (0.00%)  0
Pain in extremity  1  15/289 (5.19%)  15 14/149 (9.40%)  14 0/95 (0.00%)  0 0/95 (0.00%)  0
Nervous system disorders         
Dizziness  1  14/289 (4.84%)  14 10/149 (6.71%)  10 0/95 (0.00%)  0 0/95 (0.00%)  0
Headache  1  22/289 (7.61%)  22 11/149 (7.38%)  11 0/95 (0.00%)  0 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  26/289 (9.00%)  26 15/149 (10.07%)  15 0/95 (0.00%)  0 0/95 (0.00%)  0
Dyspnea  1  12/289 (4.15%)  12 7/149 (4.70%)  7 0/95 (0.00%)  0 0/95 (0.00%)  0
Hypotension  1  15/289 (5.19%)  15 12/149 (8.05%)  12 0/95 (0.00%)  0 0/95 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  14/289 (4.84%)  14 10/149 (6.71%)  10 0/95 (0.00%)  0 0/95 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Keryx Biopharmaceuticals Inc
Phone: 1-844-44-KERYX (1-844-445-3799
EMail: medicalinfo@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01191255     History of Changes
Obsolete Identifiers: NCT01510106
Other Study ID Numbers: KRX-0502-304
First Submitted: August 26, 2010
First Posted: August 30, 2010
Results First Submitted: October 4, 2014
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014