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Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease

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: NCT00364858
Recruitment Status : Completed
First Posted : August 16, 2006
Results First Posted : September 2, 2009
Last Update Posted : April 3, 2015
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gaucher Disease, Type 1
Cerebroside Lipidosis Syndrome
Glucocerebrosidase Deficiency Disease
Glucosylceramide Beta-Glucosidase Deficiency Disease
Gaucher Disease, Non-Neuronopathic Form
Intervention Drug: Cerezyme
Enrollment 95
Recruitment Details Eligible patients were randomized 2:1 to receive Cerezyme either once every 4 weeks (Q4) or once every 2 weeks (Q2) for 24 months. The studied period was from 14 December 2001 through 01 February 2007. There were 26 centers worldwide (18 United States, 1 Canada, 6 Europe, and 1 Brazil); 25 centers randomized patients to treatment.
Pre-assignment Details  
Arm/Group Title Q2 Cerezyme Q4 Cerezyme
Hide Arm/Group Description Patients receiving Cerezyme one infusion every 2 weeks (Q2). Patients receiving Cerezyme one infusion every 4 weeks(Q4).
Period Title: Overall Study
Started 33 62
Completed 26 40
Not Completed 7 22
Reason Not Completed
Adverse Event             1             5
Withdrawal by Subject             1             1
Pregnancy             1             1
Clinical failure             2             13
Discontinuation at baseline             1             0
Non-compliant             1             0
Return to Q2 regimen             0             1
Clinical baseline issue             0             1
Arm/Group Title Q2 Cerezyme Q4 Cerezyme Total
Hide Arm/Group Description Patients receiving Cerezyme one infusion every 2 weeks (Q2). Patients receiving Cerezyme one infusion every 4 weeks(Q4). Total of all reporting groups
Overall Number of Baseline Participants 33 62 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 62 participants 95 participants
44.8  (17.40) 47.8  (14.47) 46.8  (15.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 62 participants 95 participants
Female
13
  39.4%
34
  54.8%
47
  49.5%
Male
20
  60.6%
28
  45.2%
48
  50.5%
1.Primary Outcome
Title Number of Participants With Clinical Success at Month 24/Discontinuation
Hide Description Patients are considered to be a clinical success if ALL of the following are met: The patient’s hemoglobin does not fall more than 1.25g/dL for women or 1.5 g/dL for men below the patient’s baseline value, platelet count does not fall more than 25% below the patient’s baseline value or does not fall below 80,000 mm3, liver and spleen volumes are not greater than 20% above the patient’s baseline value, no evidence of bone disease progression, including no incidence of pathologic fractures, medullary infarctions, lytic lesions or avascular necrosis and has had no bone crises during the study.
Time Frame Month 24 (or at time of discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population. All patients who enrolled in the study and received AT LEAST ONE infusion were included in the ITT population.
Arm/Group Title Q2 Cerezyme Q4 Cerezyme
Hide Arm/Group Description:
Patients receiving Cerezyme one infusion every 2 weeks (Q2).
Patients receiving Cerezyme one infusion every 4 weeks(Q4).
Overall Number of Participants Analyzed 26 57
Measure Type: Number
Unit of Measure: patients
Number of participants with Clinical Success 21 36
Proportion of participants with Clinical Success 0.808 0.632
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Q2 Cerezyme, Q4 Cerezyme
Comments Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Agresti and Min
Estimated Value -0.176
Confidence Interval 95%
-0.357 to 0.058
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Composite Scores of the SF-36 Health Survey at Baseline
Hide Description The mean composite scores (0 being worst and 100 being best) for both treatment groups at Baseline. Composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Quality of life was evaluated and measured by the SF-36 questionnaire.
Arm/Group Title Q2 Cerezyme Q4 Cerezyme
Hide Arm/Group Description:
Patients receiving Cerezyme one infusion every 2 weeks (Q2).
Patients receiving Cerezyme one infusion every 4 weeks(Q4).
Overall Number of Participants Analyzed 33 61
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Composite Physical Health 49.8  (8.41) 46.9  (10.26)
Composite Mental Health 52.9  (7.6) 53.0  (8.47)
3.Secondary Outcome
Title Mean Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation.
Hide Description The mean composite scores (0 being worst and 100 being best) for both treatment groups at Month 24/Discontinuation. The mean composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.
Time Frame Month 24 (or at time of discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Quality of life was evaluated and measured by the SF-36 questionnaire.
Arm/Group Title Q2 Cerezyme Q4 Cerezyme
Hide Arm/Group Description:
Patients receiving Cerezyme one infusion every 2 weeks (Q2).
Patients receiving Cerezyme one infusion every 4 weeks(Q4).
Overall Number of Participants Analyzed 25 53
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Composite Physical Health 49.1  (7.52) 46.2  (12.39)
Composite Mental Health 53.8  (8.47) 52.6  (7.35)
4.Secondary Outcome
Title Mean Change From Baseline in Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation
Hide Description The mean composite scores (0 being worst and 100 being best) for both treatment groups approximated those of the general population at baseline. Composite score - The overall composite scores were comprised of a standardized physical and mental component score.
Time Frame Baseline and Month 24 (or at time of discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Quality of life was evaluated and measured by the SF-36 questionnaire.
Arm/Group Title Q2 Cerezyme Q4 Cerezyme
Hide Arm/Group Description:
Patients receiving Cerezyme one infusion every 2 weeks (Q2).
Patients receiving Cerezyme one infusion every 4 weeks(Q4).
Overall Number of Participants Analyzed 25 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Composite Physical Health -1.5  (7.40) -0.5  (7.33)
Composite Mental Health 0.6  (6.48) -0.5  (7.34)
Time Frame [Not Specified]
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title Q2 Cerezyme Q4 Cerezyme Total
Hide Arm/Group Description Patients receiving Cerezyme one infusion every 2 weeks (Q2). Patients receiving Cerezyme one infusion every 4 weeks(Q4). Total of all reporting groups
All-Cause Mortality
Q2 Cerezyme Q4 Cerezyme Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Q2 Cerezyme Q4 Cerezyme Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/33 (21.21%)   4/62 (6.45%)   11/95 (11.58%) 
Cardiac disorders       
Cardiac failure congestive  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Eye disorders       
Blindness  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Gastrointestinal disorders       
Duodenitis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Gastritis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Injury, poisoning and procedural complications       
Eye injury  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Fibula fracture  1  2/33 (6.06%)  0/62 (0.00%)  2/95 (2.11%) 
Procedural hypotension  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Road traffic accident  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Tibia fracture  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Metabolism and nutrition disorders       
Hyponatraemia  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Multiple myeloma  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Non-Hodgkin's lymphoma  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Nervous system disorders       
Parkinson's disease  1  2/33 (6.06%)  0/62 (0.00%)  2/95 (2.11%) 
Renal and urinary disorders       
Renal failure  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Vascular disorders       
Aortic dilatation  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Q2 Cerezyme Q4 Cerezyme Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/33 (60.61%)   51/62 (82.26%)   71/95 (74.74%) 
Blood and lymphatic system disorders       
Anaemia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Splenic infarction  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Splenomegaly  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Thrombocytopenia  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Cardiac disorders       
Cardiomegaly  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Palpitations  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Supraventricular tachycardia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Congenital, familial and genetic disorders       
Spondylolisthesis  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Ear and labyrinth disorders       
Deafness bilateral  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Tinnitus  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Endocrine disorders       
Hypothyroidism  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Eye disorders       
Cataract  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Conjunctival haemorrhage  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Vision blurred  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Gastrointestinal disorders       
Abdominal pain  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Abdominal pain upper  1  0/33 (0.00%)  3/62 (4.84%)  3/95 (3.16%) 
Acquired oesophageal web  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Colonic polyp  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Constipation  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Diarrhoea  1  1/33 (3.03%)  2/62 (3.23%)  3/95 (3.16%) 
Duodenitis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Gastritis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Gastrooesophageal reflux disease  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Inguinal hernia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Nausea  1  1/33 (3.03%)  2/62 (3.23%)  3/95 (3.16%) 
Oral mucosa erosion  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Stomach discomfort  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Vomiting  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
General disorders       
Asthenia  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Fatigue  1  0/33 (0.00%)  6/62 (9.68%)  6/95 (6.32%) 
Feeling hot  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Ill-defined disorder  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Infusion site erythema  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Infusion site pain  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Irritability  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Non-cardiac chest pain  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Oedema peripheral  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Pyrexia  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Immune system disorders       
Hypersensitivity  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Multiple allergies  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Infections and infestations       
Acariasis  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Bronchitis  1  0/33 (0.00%)  3/62 (4.84%)  3/95 (3.16%) 
Bronchitis acute  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Cystitis  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Furuncle  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Gastroenteritis viral  1  0/33 (0.00%)  4/62 (6.45%)  4/95 (4.21%) 
Influenza  1  0/33 (0.00%)  4/62 (6.45%)  4/95 (4.21%) 
Laryngitis  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Nail bed infection  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Nasopharyngitis  1  1/33 (3.03%)  3/62 (4.84%)  4/95 (4.21%) 
Otitis externa  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Otitis media  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Pneumonia  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Sinusitis  1  2/33 (6.06%)  5/62 (8.06%)  7/95 (7.37%) 
Tinea versicolour  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Upper respiratory tract infection  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Urinary tract infection  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Wound infection  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Contusion  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Fall  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Foot fracture  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Hand fracture  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Joint dislocation  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Joint sprain  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Ligament rupture  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Meniscus lesion  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Mountain sickness acute  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Muscle strain  1  2/33 (6.06%)  0/62 (0.00%)  2/95 (2.11%) 
Post-traumatic pain  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Procedural pain  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Spinal cord injury lumbar  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Tendon injury  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Tibia fracture  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Wrist fracture  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Investigations       
Antibody test positive  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Blood pressure increased  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Breath sounds abnormal  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Cardiac murmur  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Computerised tomogram abdomen abnormal  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Haemoglobin decreased  1  0/33 (0.00%)  5/62 (8.06%)  5/95 (5.26%) 
Platelet count decreased  1  0/33 (0.00%)  5/62 (8.06%)  5/95 (5.26%) 
Prostatic specific antigen increased  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Weight increased  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
White blood cells urine positive  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Metabolism and nutrition disorders       
Dehydration  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Fluid overload  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Folate deficiency  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Gout  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Hypercholesterolaemia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Vitamin B12 deficiency  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/33 (9.09%)  10/62 (16.13%)  13/95 (13.68%) 
Back pain  1  0/33 (0.00%)  10/62 (16.13%)  10/95 (10.53%) 
Bone lesion  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Bone pain  1  2/33 (6.06%)  5/62 (8.06%)  7/95 (7.37%) 
Flank pain  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Joint range of motion decreased  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Muscle spasms  1  3/33 (9.09%)  1/62 (1.61%)  4/95 (4.21%) 
Muscular weakness  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Musculoskeletal pain  1  3/33 (9.09%)  4/62 (6.45%)  7/95 (7.37%) 
Myalgia  1  1/33 (3.03%)  2/62 (3.23%)  3/95 (3.16%) 
Neck pain  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Nodal osteoarthritis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Osteoarthritis  1  2/33 (6.06%)  0/62 (0.00%)  2/95 (2.11%) 
Osteopenia  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Pain in extremity  1  2/33 (6.06%)  5/62 (8.06%)  7/95 (7.37%) 
Spinal column stenosis  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Weight bearing difficulty  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Haemangioma  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Lipoma  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Osteoma  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Skin cancer  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Uterine leiomyoma  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Nervous system disorders       
Cervical root pain  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Cervicobrachial syndrome  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Dizziness  1  2/33 (6.06%)  1/62 (1.61%)  3/95 (3.16%) 
Headache  1  2/33 (6.06%)  6/62 (9.68%)  8/95 (8.42%) 
Hypoaesthesia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Intention tremor  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Migraine  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Neuralgia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Parkinson's disease  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Parkinsonian gait  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Sciatica  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Sinus headache  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Syncope vasovagal  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Tremor  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Psychiatric disorders       
Affect lability  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Anxiety  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Depression  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Listless  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Renal cyst  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Urinary retention  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Urine flow decreased  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Reproductive system and breast disorders       
Menorrhagia  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Ovarian cyst  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Polycystic ovaries  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/33 (3.03%)  4/62 (6.45%)  5/95 (5.26%) 
Dyspnoea  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Epistaxis  1  0/33 (0.00%)  2/62 (3.23%)  2/95 (2.11%) 
Nasal congestion  1  1/33 (3.03%)  2/62 (3.23%)  3/95 (3.16%) 
Pharyngeal erythema  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Pleural effusion  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Postnasal drip  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Rales  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Skin and subcutaneous tissue disorders       
Acne  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Actinic keratosis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Alopecia effluvium  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Dermal cyst  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Dry skin  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Ecchymosis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Pruritus  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Rash  1  1/33 (3.03%)  1/62 (1.61%)  2/95 (2.11%) 
Skin irritation  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Skin nodule  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Stasis dermatitis  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Urticaria  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Urticaria localised  1  1/33 (3.03%)  0/62 (0.00%)  1/95 (1.05%) 
Vascular disorders       
Hypertension  1  1/33 (3.03%)  3/62 (4.84%)  4/95 (4.21%) 
Hypotension  1  0/33 (0.00%)  1/62 (1.61%)  1/95 (1.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Responsible Party: Medical Monitor, Genzyme Coporation
ClinicalTrials.gov Identifier: NCT00364858     History of Changes
Other Study ID Numbers: CZ-011-01
First Submitted: August 15, 2006
First Posted: August 16, 2006
Results First Submitted: May 28, 2009
Results First Posted: September 2, 2009
Last Update Posted: April 3, 2015