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An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

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ClinicalTrials.gov Identifier: NCT01194973
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : April 24, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atypical Hemolytic-Uremic Syndrome
Intervention Drug: Eculizumab
Enrollment 44
Recruitment Details A total of 44 patients diagnosed with aHUS signed the informed consent and of these, 41 patients were treated. Three patients were excluded from the study due to failed screening procedure and did not receive eculizumab.
Pre-assignment Details At screening, patients had to have signs or symptoms of hemolysis; serum creatinine level ≥ ULN and platelet count < LLN
Arm/Group Title Eculizumab
Hide Arm/Group Description Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Period Title: Screening Period
Started 44
Completed 41
Not Completed 3
Reason Not Completed
Screen Failure             3
Period Title: 26 Week Treatment Period
Started 41
Completed 38
Not Completed 3
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Pregnancy             1
Arm/Group Title Eculizumab
Hide Arm/Group Description Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 41 patients who were treated with study drug were included in the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
40.3  (15.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
28
  68.3%
Male
13
  31.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.9%
White
38
  92.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Patients With Complete TMA Response
Hide Description Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
73.2
(57.1 to 85.8)
2.Primary Outcome
Title Percentage of Patients With Modified Complete TMA Response
Hide Description Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
56.1
(39.7 to 71.5)
3.Secondary Outcome
Title Percentage of Patients With Complete Hematologic Response
Hide Description Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
87.8
(73.8 to 95.9)
4.Secondary Outcome
Title Percentage of Patients With Platelet Count Normalization
Hide Description Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
97.6
(87.1 to 99.9)
5.Secondary Outcome
Title Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement
Hide Description Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
53.7
(37.4 to 69.3)
6.Secondary Outcome
Title Platelet Count Change From Baseline to 26 Weeks
Hide Description [Not Specified]
Time Frame Through 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline platelet counts were analyzed for the ITT population using a repeated measures Analysis of variance (ANOVA) model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: 10^9 cells/L
117.68
(92.77 to 142.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eculizumab
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 ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean change from baseline
Estimated Value 117.68
Confidence Interval (2-Sided) 95%
92.77 to 142.59
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients With Complete TMA Response
Hide Description Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through End of Study, Median Exposure 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
80.5
(65.1 to 91.2)
8.Secondary Outcome
Title Percentage of Patients With Modified Complete TMA Response
Hide Description Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through End of Study, Median Exposure 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
63.4
(46.9 to 77.9)
9.Secondary Outcome
Title Percentage of Patients With Complete Hematologic Response
Hide Description Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.
Time Frame Through End of Study, Median Exposure 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
97.6
(87.1 to 99.9)
10.Secondary Outcome
Title Percentage of Patients With Platelet Count Normalization
Hide Description Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks
Time Frame Through End of Study, Median Exposure 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(91.4 to 100.0)
11.Secondary Outcome
Title Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement
Hide Description Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart
Time Frame Through End of Study, Median Exposure 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
61.0
(44.5 to 75.8)
12.Secondary Outcome
Title Platelet Count Change From Baseline to 52 Weeks
Hide Description [Not Specified]
Time Frame Through 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.
Arm/Group Title Eculizumab
Hide Arm/Group Description:
Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: 10^9 cells/L
102.49
(68.15 to 136.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eculizumab
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 ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean change from baseline
Estimated Value 102.49
Confidence Interval (2-Sided) 95%
68.15 to 136.82
Estimation Comments [Not Specified]
Time Frame Through end of study; exposure to eculizumab in this study extended for a median duration of 11.9 months and ranged from 2.9 months to 28.8 months
Adverse Event Reporting Description At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
 
Arm/Group Title Eculizumab
Hide Arm/Group Description Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
All-Cause Mortality
Eculizumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Eculizumab
Affected / at Risk (%)
Total   19/41 (46.34%) 
Blood and lymphatic system disorders   
Haemolytic uraemic syndrome  1  1/41 (2.44%) 
Thrombotic microangiopathy  1  1/41 (2.44%) 
Gastrointestinal disorders   
Abdominal pain  1  1/41 (2.44%) 
Diarrhoea  1  1/41 (2.44%) 
Gastrointestinal haemorrhage  1  1/41 (2.44%) 
General disorders   
Medical device complication  1  1/41 (2.44%) 
Immune system disorders   
Kidney transplant rejection  1  1/41 (2.44%) 
Infections and infestations   
Bronchitis  1  1/41 (2.44%) 
Device related infection  1  1/41 (2.44%) 
Device related sepsis  1  2/41 (4.88%) 
Genitourinary tract gonococcal infection  1  1/41 (2.44%) 
Meningitis meningococcal  1  1/41 (2.44%) 
Meningococcal sepsis  1  1/41 (2.44%) 
Pneumonia  1  1/41 (2.44%) 
Pyelonephritis  1  2/41 (4.88%) 
Shunt infection  1  1/41 (2.44%) 
Injury, poisoning and procedural complications   
Shunt malfunction  1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/41 (2.44%) 
Hypoglycemia  1  1/41 (2.44%) 
Nervous system disorders   
Convulsion  1  2/41 (4.88%) 
Haemorrhage intracranial  1  1/41 (2.44%) 
Paraesthesia  1  1/41 (2.44%) 
Posterior reversible encephalopathy syndrome  1  1/41 (2.44%) 
Renal and urinary disorders   
Renal failure acute  1  2/41 (4.88%) 
Renal failure chronic  1  2/41 (4.88%) 
Renal impairment  1  2/41 (4.88%) 
Renal vessel disorder  1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/41 (4.88%) 
Pulmonary oedema  1  2/41 (4.88%) 
Respiratory failure  1  1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
Rash papular  1  1/41 (2.44%) 
Skin necrosis  1  1/41 (2.44%) 
Vascular disorders   
Hypertension  1  1/41 (2.44%) 
Hypertensive crisis  1  1/41 (2.44%) 
Venous thrombosis  1  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eculizumab
Affected / at Risk (%)
Total   41/41 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  7/41 (17.07%) 
EOSINOPHILIA  1  1/41 (2.44%) 
IRON DEFICIENCY ANAEMIA  1  1/41 (2.44%) 
LEUKOPENIA  1  5/41 (12.20%) 
LYMPHOPENIA  1  3/41 (7.32%) 
NEUTROPENIA  1  2/41 (4.88%) 
SPONTANEOUS HAEMATOMA  1  1/41 (2.44%) 
THROMBOCYTOPENIA  1  2/41 (4.88%) 
Cardiac disorders   
ANGINA PECTORIS  1  1/41 (2.44%) 
CARDIOMYOPATHY  1  1/41 (2.44%) 
PALPITATIONS  1  1/41 (2.44%) 
TACHYCARDIA  1  2/41 (4.88%) 
Ear and labyrinth disorders   
EAR PAIN  1  1/41 (2.44%) 
TINNITUS  1  1/41 (2.44%) 
TYMPANIC MEMBRANE PERFORATION  1  1/41 (2.44%) 
VERTIGO  1  3/41 (7.32%) 
Endocrine disorders   
HYPERPARATHYROIDISM  1  2/41 (4.88%) 
Eye disorders   
CONJUNCTIVAL HAEMORRHAGE  1  1/41 (2.44%) 
CONJUNCTIVITIS  1  1/41 (2.44%) 
EYE INFLAMMATION  1  1/41 (2.44%) 
LACRIMATION INCREASED  1  1/41 (2.44%) 
RETINOPATHY HYPERTENSIVE  1  2/41 (4.88%) 
UVEITIS  1  1/41 (2.44%) 
VISION BLURRED  1  1/41 (2.44%) 
Gastrointestinal disorders   
ABDOMINAL DISCOMFORT  1  1/41 (2.44%) 
ABDOMINAL PAIN  1  3/41 (7.32%) 
ABDOMINAL PAIN UPPER  1  2/41 (4.88%) 
CONSTIPATION  1  3/41 (7.32%) 
DIARRHOEA  1  13/41 (31.71%) 
DRY MOUTH  1  1/41 (2.44%) 
DYSPEPSIA  1  1/41 (2.44%) 
DYSPHAGIA  1  1/41 (2.44%) 
ENTERITIS  1  2/41 (4.88%) 
GASTROINTESTINAL DISORDER  1  1/41 (2.44%) 
GASTROINTESTINAL PAIN  1  1/41 (2.44%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/41 (2.44%) 
GINGIVAL HYPERTROPHY  1  1/41 (2.44%) 
MOUTH ULCERATION  1  1/41 (2.44%) 
NAUSEA  1  5/41 (12.20%) 
ODYNOPHAGIA  1  2/41 (4.88%) 
STOMATITIS  1  1/41 (2.44%) 
VOMITING  1  6/41 (14.63%) 
General disorders   
ASTHENIA  1  6/41 (14.63%) 
CALCINOSIS  1  1/41 (2.44%) 
CATHETER SITE DISCHARGE  1  1/41 (2.44%) 
CATHETER SITE ERYTHEMA  1  1/41 (2.44%) 
CATHETER SITE PRURITUS  1  1/41 (2.44%) 
CHEST DISCOMFORT  1  1/41 (2.44%) 
CHEST PAIN  1  2/41 (4.88%) 
CHILLS  1  1/41 (2.44%) 
DEVICE OCCLUSION  1  1/41 (2.44%) 
FATIGUE  1  3/41 (7.32%) 
IMPAIRED HEALING  1  1/41 (2.44%) 
INFLUENZA LIKE ILLNESS  1  1/41 (2.44%) 
MALAISE  1  1/41 (2.44%) 
MEDICAL DEVICE COMPLICATION  1  2/41 (4.88%) 
OEDEMA  1  2/41 (4.88%) 
OEDEMA PERIPHERAL  1  9/41 (21.95%) 
PYREXIA  1  7/41 (17.07%) 
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/41 (2.44%) 
CHOLELITHIASIS  1  1/41 (2.44%) 
CHOLESTASIS  1  2/41 (4.88%) 
HEPATOCELLULAR INJURY  1  1/41 (2.44%) 
Infections and infestations   
ASYMPTOMATIC BACTERIURIA  1  1/41 (2.44%) 
BACTERIAL INFECTION  1  1/41 (2.44%) 
BACTERIURIA  1  1/41 (2.44%) 
BK VIRUS INFECTION  1  1/41 (2.44%) 
BRONCHITIS  1  5/41 (12.20%) 
BRONCHITIS VIRAL  1  1/41 (2.44%) 
CATHETER SITE INFECTION  1  1/41 (2.44%) 
CYSTITIS  1  1/41 (2.44%) 
DENTAL GANGRENE  1  1/41 (2.44%) 
DEVICE RELATED INFECTION  1  1/41 (2.44%) 
DEVICE RELATED SEPSIS  1  1/41 (2.44%) 
EAR INFECTION  1  1/41 (2.44%) 
ERYSIPELAS  1  1/41 (2.44%) 
FOLLICULITIS  1  1/41 (2.44%) 
GASTROENTERITIS  1  3/41 (7.32%) 
GENITAL INFECTION FUNGAL  1  1/41 (2.44%) 
HERPES ZOSTER  1  1/41 (2.44%) 
INFECTION  1  1/41 (2.44%) 
INFLUENZA  1  2/41 (4.88%) 
LARYNGITIS  1  1/41 (2.44%) 
LUNG INFECTION  1  1/41 (2.44%) 
LYMPHANGITIS  1  1/41 (2.44%) 
NASOPHARYNGITIS  1  8/41 (19.51%) 
ONYCHOMYCOSIS  1  1/41 (2.44%) 
ORAL FUNGAL INFECTION  1  1/41 (2.44%) 
ORAL HERPES  1  3/41 (7.32%) 
OTITIS MEDIA  1  1/41 (2.44%) 
PHARYNGITIS  1  1/41 (2.44%) 
PULMONARY SEPSIS  1  1/41 (2.44%) 
PYELONEPHRITIS  1  1/41 (2.44%) 
RESPIRATORY TRACT INFECTION  1  1/41 (2.44%) 
RHINITIS  1  3/41 (7.32%) 
SINUSITIS  1  2/41 (4.88%) 
STAPHYLOCOCCAL INFECTION  1  2/41 (4.88%) 
TINEA PEDIS  1  1/41 (2.44%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/41 (2.44%) 
URINARY TRACT INFECTION  1  7/41 (17.07%) 
VAGINITIS BACTERIAL  1  1/41 (2.44%) 
VIRAL INFECTION  1  2/41 (4.88%) 
Injury, poisoning and procedural complications   
ARTERIOVENOUS FISTULA SITE COMPLICATION  1  1/41 (2.44%) 
CONTUSION  1  1/41 (2.44%) 
FOOT FRACTURE  1  1/41 (2.44%) 
INFUSION RELATED REACTION  1  1/41 (2.44%) 
PROCEDURAL COMPLICATION  1  1/41 (2.44%) 
SHUNT MALFUNCTION  1  1/41 (2.44%) 
SKELETAL INJURY  1  1/41 (2.44%) 
UPPER LIMB FRACTURE  1  1/41 (2.44%) 
WOUND  1  1/41 (2.44%) 
Investigations   
BLOOD PRESSURE INCREASED  1  1/41 (2.44%) 
CARDIAC MURMUR  1  2/41 (4.88%) 
EOSINOPHIL COUNT INCREASED  1  2/41 (4.88%) 
FREE HAEMOGLOBIN PRESENT  1  1/41 (2.44%) 
LIVER FUNCTION TEST ABNORMAL  1  1/41 (2.44%) 
PLATELET COUNT DECREASED  1  2/41 (4.88%) 
URINE PROTEIN/CREATININE RATIO INCREASED  1  1/41 (2.44%) 
WEIGHT DECREASED  1  1/41 (2.44%) 
WHITE BLOOD CELL COUNT INCREASED  1  1/41 (2.44%) 
Metabolism and nutrition disorders   
ACIDOSIS  1  2/41 (4.88%) 
DECREASED APPETITE  1  1/41 (2.44%) 
DEHYDRATION  1  1/41 (2.44%) 
ELECTROLYTE IMBALANCE  1  1/41 (2.44%) 
HYPERCALCAEMIA  1  1/41 (2.44%) 
HYPERCREATININAEMIA  1  2/41 (4.88%) 
HYPERKALAEMIA  1  4/41 (9.76%) 
HYPERPHOSPHATAEMIA  1  5/41 (12.20%) 
HYPERURICAEMIA  1  1/41 (2.44%) 
HYPERVOLAEMIA  1  2/41 (4.88%) 
HYPOCALCAEMIA  1  3/41 (7.32%) 
HYPOGLYCAEMIA  1  1/41 (2.44%) 
HYPOKALAEMIA  1  4/41 (9.76%) 
HYPOMAGNESAEMIA  1  1/41 (2.44%) 
HYPOPHOSPHATAEMIA  1  4/41 (9.76%) 
IRON DEFICIENCY  1  1/41 (2.44%) 
METABOLIC ACIDOSIS  1  1/41 (2.44%) 
OVERWEIGHT  1  1/41 (2.44%) 
TYPE 2 DIABETES MELLITUS  1  1/41 (2.44%) 
VITAMIN D DEFICIENCY  1  4/41 (9.76%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  8/41 (19.51%) 
BACK PAIN  1  3/41 (7.32%) 
BONE PAIN  1  1/41 (2.44%) 
CHONDROCALCINOSIS  1  1/41 (2.44%) 
HAEMARTHROSIS  1  1/41 (2.44%) 
JOINT EFFUSION  1  1/41 (2.44%) 
JOINT STIFFNESS  1  1/41 (2.44%) 
MUSCLE SPASMS  1  1/41 (2.44%) 
MUSCULOSKELETAL PAIN  1  2/41 (4.88%) 
MYALGIA  1  4/41 (9.76%) 
NECK PAIN  1  2/41 (4.88%) 
OSTEOPENIA  1  1/41 (2.44%) 
PAIN IN EXTREMITY  1  2/41 (4.88%) 
RHABDOMYOLYSIS  1  1/41 (2.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PARATHYROID TUMOUR BENIGN  1  1/41 (2.44%) 
Nervous system disorders   
AMNESIA  1  1/41 (2.44%) 
DIZZINESS  1  2/41 (4.88%) 
HEADACHE  1  15/41 (36.59%) 
LOSS OF CONSCIOUSNESS  1  1/41 (2.44%) 
MIGRAINE  1  2/41 (4.88%) 
PARAESTHESIA  1  3/41 (7.32%) 
POLYNEUROPATHY  1  1/41 (2.44%) 
PRESYNCOPE  1  1/41 (2.44%) 
SCIATICA  1  1/41 (2.44%) 
SYNCOPE  1  1/41 (2.44%) 
TREMOR  1  1/41 (2.44%) 
Psychiatric disorders   
AGITATION  1  1/41 (2.44%) 
ANXIETY  1  4/41 (9.76%) 
DEPRESSED MOOD  1  2/41 (4.88%) 
DEPRESSION  1  3/41 (7.32%) 
INSOMNIA  1  5/41 (12.20%) 
NIGHTMARE  1  1/41 (2.44%) 
Renal and urinary disorders   
ANURIA  1  1/41 (2.44%) 
DYSURIA  1  1/41 (2.44%) 
HAEMATURIA  1  1/41 (2.44%) 
PROTEINURIA  1  5/41 (12.20%) 
RENAL FAILURE ACUTE  1  1/41 (2.44%) 
RENAL FAILURE CHRONIC  1  2/41 (4.88%) 
RENAL IMPAIRMENT  1  6/41 (14.63%) 
RENAL VESSEL DISORDER  1  1/41 (2.44%) 
TUBULOINTERSTITIAL NEPHRITIS  1  1/41 (2.44%) 
URINE ABNORMALITY  1  1/41 (2.44%) 
VESICOURETERIC REFLUX  1  1/41 (2.44%) 
Reproductive system and breast disorders   
AMENORRHOEA  1  2/41 (4.88%) 
ATROPHIC VULVOVAGINITIS  1  1/41 (2.44%) 
BREAST CYST  1  1/41 (2.44%) 
DYSMENORRHOEA  1  2/41 (4.88%) 
ENDOMETRIOSIS  1  1/41 (2.44%) 
HAEMATOSPERMIA  1  1/41 (2.44%) 
METRORRHAGIA  1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  7/41 (17.07%) 
DYSPNOEA  1  5/41 (12.20%) 
DYSPNOEA EXERTIONAL  1  2/41 (4.88%) 
EPISTAXIS  1  1/41 (2.44%) 
NASAL SEPTUM DEVIATION  1  1/41 (2.44%) 
OROPHARYNGEAL PAIN  1  3/41 (7.32%) 
PLEURAL EFFUSION  1  1/41 (2.44%) 
PRODUCTIVE COUGH  1  2/41 (4.88%) 
PULMONARY CONGESTION  1  1/41 (2.44%) 
PULMONARY OEDEMA  1  1/41 (2.44%) 
RHINITIS ALLERGIC  1  1/41 (2.44%) 
RHINORRHOEA  1  2/41 (4.88%) 
SNORING  1  1/41 (2.44%) 
WHEEZING  1  1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
ALOPECIA  1  5/41 (12.20%) 
DERMATITIS  1  1/41 (2.44%) 
ECZEMA  1  2/41 (4.88%) 
ERYTHEMA  1  2/41 (4.88%) 
INTERTRIGO  1  1/41 (2.44%) 
NIGHT SWEATS  1  1/41 (2.44%) 
PETECHIAE  1  1/41 (2.44%) 
PHOTOSENSITIVITY REACTION  1  1/41 (2.44%) 
PRURITUS  1  4/41 (9.76%) 
PURPURA  1  2/41 (4.88%) 
RASH  1  4/41 (9.76%) 
RASH ERYTHEMATOUS  1  1/41 (2.44%) 
RASH PRURITIC  1  2/41 (4.88%) 
SKIN DISCOLOURATION  1  1/41 (2.44%) 
URTICARIA  1  2/41 (4.88%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/41 (2.44%) 
HAEMATOMA  1  3/41 (7.32%) 
HOT FLUSH  1  1/41 (2.44%) 
HYPERTENSION  1  5/41 (12.20%) 
HYPOTENSION  1  7/41 (17.07%) 
STEAL SYNDROME  1  1/41 (2.44%) 
THROMBOPHLEBITIS  1  1/41 (2.44%) 
VENOUS THROMBOSIS  1  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Participation in this multicenter study involved a commitment to publish the data from the study in a cooperative publication prior to release of study results on an individual basis.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alexion Pharmaceuticals Inc
Organization: Alexion Pharmaceuticals Inc
EMail: clinicaltrials@alexion.com
Layout table for additonal information
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01194973    
Other Study ID Numbers: C10-004
First Submitted: August 31, 2010
First Posted: September 3, 2010
Results First Submitted: April 7, 2015
Results First Posted: April 24, 2015
Last Update Posted: May 30, 2017