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Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00328198
Recruitment Status : Completed
First Posted : May 19, 2006
Results First Posted : August 10, 2012
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Intervention Biological: Alemtuzumab
Enrollment 86
Recruitment Details  
Pre-assignment Details 109 patients screened and 86 enrolled and treated.
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Period Title: Treatment
Started 86 [1]
Completed 48 [2]
Not Completed 38
Reason Not Completed
Adverse Event             21
Death             1
Physician Decision             5
Withdrawal by Subject             5
Evidence of disease progression             2
Non-compliance             1
Confirmed complete response, MRD -             3
[1]
16 participants escalated the dose. 70 participants started at the 30 mg target dose.
[2]
Depending upon protocol version, completed treatment was either 12 or 18 weeks in duration.
Period Title: Follow-up
Started 78 [1]
Completed 43
Not Completed 35
Reason Not Completed
Lost to Follow-up             4
Death             31
[1]
Eight participants did not enter Follow-up
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Baseline Participants 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants
65.32  (9.035)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Female
29
  33.7%
Male
57
  66.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants
American Indian or Alaska Native 0
Asian 1
Native Hawaiian or Other Pacific Islander 0
Black or African American 2
White 82
Other 1
Current Rai Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants
Rai Stage 0 7
Rai Stage I 10
Rai Stage II 22
Rai Stage III 7
Rai Stage IV 40
[1]
Measure Description:

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity. Data represents the Rai Stage when the participant entered the study.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly, Rai Stage III Lymphocytosis with anemia, Rai Stage IV Lymphocytosis with thrombocytopenia

Current Binet Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants
Stage A 20
Stage B 22
Stage C 44
[1]
Measure Description:

Binet staging is another way to categorize chronic lymphocytic leukemia (CLL). Data represents the Binet Stage when the participant entered the study.

Stage A CLL is characterized by no anemia or thrombocytopenia and fewer than three areas of lymphoid involvement (Rai stages 0, I, and II).

Stage B CLL is characterized by no anemia or thrombocytopenia with three or more areas of lymphoid involvement (Rai stages I and II).

Stage C CLL is characterized by anemia and/or thrombocytopenia regardless of the number of areas of lymphoid enlargement (Rai stages III and IV).

World Health Organization (WHO) Performance   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants
0 55
1 28
2 3
[1]
Measure Description:

The WHO performance status classification categorises patients as:

0: able to carry out all normal activity without restriction

  1. restricted in strenuous activity but ambulatory and able to carry out light work
  2. ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
1.Primary Outcome
Title Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)
Hide Description Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.
Time Frame up to 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: participants
Overall response (CR+PR) 37
Complete response (CR) 5
Partial response (PR) 32
Stable disease (SD) 24
Progressive disease (PD) 4
Not Evaluable (NE) 21
2.Primary Outcome
Title Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)
Hide Description Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.
Time Frame up to 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 95% confidence interval calculated using exact binomial method.
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.0
(32.4 to 54.2)
3.Secondary Outcome
Title Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)
Hide Description

Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.

Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Median (95% Confidence Interval)
Unit of Measure: months
12.43
(9.934 to 14.375)
4.Secondary Outcome
Title Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)
Hide Description

Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.

Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a complete response or a partial response
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: months
11.09
(9.013 to 14.572)
5.Secondary Outcome
Title Kaplan-Meier Estimates of Overall Survival
Hide Description Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Median (95% Confidence Interval)
Unit of Measure: months
38.29 [1] 
(30.099 to NA)
[1]
values were not calculable since there were not enough events for the statistical estimation, ie, few participants died
6.Secondary Outcome
Title Participants With a Minimal Residual Disease (MRD) Status of Negative
Hide Description MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.
Time Frame 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: participants
4
7.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.
Time Frame up to 18 weeks of treatment plus 45 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description:
Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: participants
>=1 TEAE 82
>=1 TEAE related to drug 80
>=1 injection site reaction 49
>=1 injection site reaction related to drug 48
>=1 infection 49
>=1 infection related to drug 35
>=1 serious AE 46
>=1 serious AE related to drug 39
Discontinued study drug due to AE 21
Discontinued study drug due to related AE 20
Deaths 12
Deaths within 30 days of last dose 3
TEAE with worst severity grade 1 3
TEAE with worst severity grade 2 8
TEAE with worst severity grade 3 18
TEAE with worst severity grade 4 45
TEAE with worst severity grade 5 8
Time Frame Treatment-emergent AEs: up to 18 weeks of treatment plus 45 additional days
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. Events are listed independent of relationship to treatment reported.
 
Arm/Group Title Alemtuzumab 30mg
Hide Arm/Group Description Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
All-Cause Mortality
Alemtuzumab 30mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab 30mg
Affected / at Risk (%)
Total   46/86 (53.49%) 
Blood and lymphatic system disorders   
Bone marrow failure  1  1/86 (1.16%) 
Febrile neutropenia  1  6/86 (6.98%) 
Idiopathic thrombocytopenic purpura  1  1/86 (1.16%) 
Neutropenia  1  2/86 (2.33%) 
Pancytopenia  1  4/86 (4.65%) 
Thrombocytopenia  1  2/86 (2.33%) 
Cardiac disorders   
Angina unstable  1  1/86 (1.16%) 
Atrial fibrillation  1  1/86 (1.16%) 
Left ventricular failure  1  1/86 (1.16%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  2/86 (2.33%) 
Large intestine perforation  1  1/86 (1.16%) 
Peritonitis  1  1/86 (1.16%) 
Rectal haemorrhage  1  1/86 (1.16%) 
General disorders   
Asthenia  1  1/86 (1.16%) 
Chills  1  2/86 (2.33%) 
Device dislocation  1  1/86 (1.16%) 
Localised oedema  1  1/86 (1.16%) 
Oedema peripheral  1  1/86 (1.16%) 
Pyrexia  1  6/86 (6.98%) 
Hepatobiliary disorders   
Bile duct obstruction  1  1/86 (1.16%) 
Cholangitis acute  1  1/86 (1.16%) 
Hepatorenal syndrome  1  1/86 (1.16%) 
Immune system disorders   
Hypersensitivity  1  1/86 (1.16%) 
Infections and infestations   
Abscess neck  1  1/86 (1.16%) 
Aspergillosis  1  1/86 (1.16%) 
Bacteraemia  1  1/86 (1.16%) 
Bronchitis  1  2/86 (2.33%) 
Bronchopneumonia  1  1/86 (1.16%) 
Bronchopulmonary aspergillosis  1  3/86 (3.49%) 
Cellulitis  1  3/86 (3.49%) 
Cytomegalovirus infection  1  9/86 (10.47%) 
Ear infection  1  1/86 (1.16%) 
Escherichia bacteraemia  1  1/86 (1.16%) 
Herpes zoster  1  1/86 (1.16%) 
Infection  1  1/86 (1.16%) 
Lower respiratory tract infection  1  1/86 (1.16%) 
Meningitis  1  1/86 (1.16%) 
Parainfluenzae virus infection  1  1/86 (1.16%) 
Pneumonia  1  5/86 (5.81%) 
Pneumonia fungal  1  1/86 (1.16%) 
Septic shock  1  2/86 (2.33%) 
Upper respiratory tract infection  1  2/86 (2.33%) 
Urinary tract infection  1  2/86 (2.33%) 
Injury, poisoning and procedural complications   
Fractured ischium  1  1/86 (1.16%) 
Investigations   
Cytomegalovirus test positive  1  2/86 (2.33%) 
Liver function test abnormal  1  1/86 (1.16%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/86 (1.16%) 
Diabetes mellitus  1  1/86 (1.16%) 
Hypercalcaemia  1  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/86 (1.16%) 
Polymyositis  1  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Ear neoplasm  1  1/86 (1.16%) 
Richter's syndrome  1  2/86 (2.33%) 
Nervous system disorders   
Cerebrovascular accident  1  1/86 (1.16%) 
Encephalitis  1  1/86 (1.16%) 
Headache  1  2/86 (2.33%) 
Hypoglycaemic coma  1  1/86 (1.16%) 
Sciatica  1  1/86 (1.16%) 
Renal and urinary disorders   
Nephrolithiasis  1  1/86 (1.16%) 
Renal failure acute  1  2/86 (2.33%) 
Reproductive system and breast disorders   
Oedema genital  1  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/86 (1.16%) 
Chronic obstructive pulmonary disease  1  1/86 (1.16%) 
Pleural effusion  1  1/86 (1.16%) 
Pleurisy  1  1/86 (1.16%) 
Skin and subcutaneous tissue disorders   
Leukocytoclastic vasculitis  1  1/86 (1.16%) 
Vascular disorders   
Orthostatic hypotension  1  1/86 (1.16%) 
Shock haemorrhagic  1  1/86 (1.16%) 
Venous thrombosis limb  1  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alemtuzumab 30mg
Affected / at Risk (%)
Total   81/86 (94.19%) 
Blood and lymphatic system disorders   
Anaemia  1  28/86 (32.56%) 
Anaemia haemolytic autoimmune  1  1/86 (1.16%) 
Febrile neutropenia  1  1/86 (1.16%) 
Haemolysis  1  2/86 (2.33%) 
Idiopathic thrombocytopenic purpura  1  1/86 (1.16%) 
Leukocytosis  1  1/86 (1.16%) 
Leukopenia  1  27/86 (31.40%) 
Lymphopenia  1  14/86 (16.28%) 
Neutropenia  1  43/86 (50.00%) 
Thrombocytopenia  1  17/86 (19.77%) 
Cardiac disorders   
Angina pectoris  1  1/86 (1.16%) 
Angina unstable  1  1/86 (1.16%) 
Atrial flutter  1  1/86 (1.16%) 
Bradycardia  1  1/86 (1.16%) 
Palpitations  1  3/86 (3.49%) 
Sinus tachycardia  1  1/86 (1.16%) 
Tachycardia  1  4/86 (4.65%) 
Ear and labyrinth disorders   
Ear pain  1  1/86 (1.16%) 
Vertigo  1  3/86 (3.49%) 
Endocrine disorders   
Hypothyroidism  1  1/86 (1.16%) 
Eye disorders   
Conjunctivitis  1  1/86 (1.16%) 
Dry eye  1  1/86 (1.16%) 
Erythema of eyelid  1  1/86 (1.16%) 
Eye haemorrhage  1  1/86 (1.16%) 
Eye irritation  1  1/86 (1.16%) 
Eye pain  1  1/86 (1.16%) 
Lacrimation increased  1  1/86 (1.16%) 
Gastrointestinal disorders   
Abdominal distension  1  2/86 (2.33%) 
Abdominal pain  1  7/86 (8.14%) 
Abdominal pain upper  1  5/86 (5.81%) 
Aphthous stomatitis  1  1/86 (1.16%) 
Ascites  1  1/86 (1.16%) 
Constipation  1  5/86 (5.81%) 
Diarrhoea  1  15/86 (17.44%) 
Dry mouth  1  1/86 (1.16%) 
Dyspepsia  1  2/86 (2.33%) 
Epigastric discomfort  1  1/86 (1.16%) 
Flatulence  1  1/86 (1.16%) 
Gastritis  1  1/86 (1.16%) 
Gastrointestinal disorder  1  1/86 (1.16%) 
Gastrointestinal haemorrhage  1  1/86 (1.16%) 
Gastrooesophageal reflux disease  1  1/86 (1.16%) 
Gingival pain  1  1/86 (1.16%) 
Haematochezia  1  1/86 (1.16%) 
Hiatus hernia  1  1/86 (1.16%) 
Ileus  1  1/86 (1.16%) 
Inguinal hernia  1  1/86 (1.16%) 
Melaena  1  1/86 (1.16%) 
Mouth haemorrhage  1  1/86 (1.16%) 
Mouth ulceration  1  2/86 (2.33%) 
Nausea  1  17/86 (19.77%) 
Odynophagia  1  1/86 (1.16%) 
Peptic ulcer  1  1/86 (1.16%) 
Retching  1  1/86 (1.16%) 
Stomatitis  1  3/86 (3.49%) 
Tongue coated  1  1/86 (1.16%) 
Toothache  1  2/86 (2.33%) 
Vomiting  1  14/86 (16.28%) 
General disorders   
Asthenia  1  6/86 (6.98%) 
Axillary pain  1  1/86 (1.16%) 
Catheter site haematoma  1  1/86 (1.16%) 
Chills  1  20/86 (23.26%) 
Fatigue  1  25/86 (29.07%) 
Hypothermia  1  1/86 (1.16%) 
Influenza like illness  1  1/86 (1.16%) 
Injection site erythema  1  29/86 (33.72%) 
Injection site haematoma  1  1/86 (1.16%) 
Injection site pain  1  2/86 (2.33%) 
Injection site pruritus  1  4/86 (4.65%) 
Injection site rash  1  4/86 (4.65%) 
Injection site reaction  1  14/86 (16.28%) 
Injection site swelling  1  1/86 (1.16%) 
Malaise  1  2/86 (2.33%) 
Oedema peripheral  1  8/86 (9.30%) 
Pain  1  6/86 (6.98%) 
Pyrexia  1  30/86 (34.88%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  1/86 (1.16%) 
Hyperbilirubinaemia  1  2/86 (2.33%) 
Immune system disorders   
Drug hypersensitivity  1  1/86 (1.16%) 
Hypersensitivity  1  1/86 (1.16%) 
Seasonal allergy  1  1/86 (1.16%) 
Infections and infestations   
Acute sinusitis  1  1/86 (1.16%) 
Balanitis candida  1  1/86 (1.16%) 
Bronchitis  1  2/86 (2.33%) 
Cellulitis  1  1/86 (1.16%) 
Clostridial infection  1  1/86 (1.16%) 
Cytomegalovirus infection  1  6/86 (6.98%) 
Escherichia urinary tract infection  1  1/86 (1.16%) 
Eye infection  1  1/86 (1.16%) 
Folliculitis  1  1/86 (1.16%) 
Influenza  1  1/86 (1.16%) 
Lower respiratory tract infection  1  2/86 (2.33%) 
Nasopharyngitis  1  7/86 (8.14%) 
Oesophageal candidiasis  1  1/86 (1.16%) 
Oral candidiasis  1  1/86 (1.16%) 
Oral fungal infection  1  1/86 (1.16%) 
Oral herpes  1  1/86 (1.16%) 
Oropharyngeal candidiasis  1  1/86 (1.16%) 
Pneumonia  1  2/86 (2.33%) 
Respiratory tract infection  1  4/86 (4.65%) 
Rhinitis  1  6/86 (6.98%) 
Sinusitis  1  3/86 (3.49%) 
Sinusitis aspergillus  1  1/86 (1.16%) 
Systemic candida  1  1/86 (1.16%) 
Tinea capitis  1  1/86 (1.16%) 
Tinea infection  1  1/86 (1.16%) 
Tracheitis  1  1/86 (1.16%) 
Upper respiratory tract infection  1  5/86 (5.81%) 
Urinary tract infection  1  4/86 (4.65%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/86 (1.16%) 
Contusion  1  2/86 (2.33%) 
Fall  1  1/86 (1.16%) 
Fibula fracture  1  1/86 (1.16%) 
Post procedural complication  1  1/86 (1.16%) 
Procedural pain  1  2/86 (2.33%) 
Thermal burn  1  1/86 (1.16%) 
Investigations   
Alanine aminotransferase increased  1  1/86 (1.16%) 
Aspartate aminotransferase increased  1  1/86 (1.16%) 
Beta 2 microglobulin increased  1  1/86 (1.16%) 
Blood alkaline phosphatase increased  1  2/86 (2.33%) 
Blood bilirubin increased  1  1/86 (1.16%) 
Blood creatinine increased  1  2/86 (2.33%) 
Blood iron decreased  1  1/86 (1.16%) 
Blood potassium decreased  1  2/86 (2.33%) 
Blood pressure increased  1  1/86 (1.16%) 
Blood urea increased  1  1/86 (1.16%) 
Body temperature increased  1  1/86 (1.16%) 
CD4 lymphocytes decreased  1  1/86 (1.16%) 
Cytomegalovirus test positive  1  13/86 (15.12%) 
Eosinophil count increased  1  1/86 (1.16%) 
Gamma-glutamyltransferase increased  1  1/86 (1.16%) 
International normalised ratio increased  1  1/86 (1.16%) 
Neutrophil count decreased  1  1/86 (1.16%) 
Protein total decreased  1  2/86 (2.33%) 
Serum ferritin increased  1  1/86 (1.16%) 
Weight decreased  1  8/86 (9.30%) 
White blood cell count decreased  1  1/86 (1.16%) 
Metabolism and nutrition disorders   
Decreased appetite  1  12/86 (13.95%) 
Fluid retention  1  2/86 (2.33%) 
Hyperglycaemia  1  2/86 (2.33%) 
Hyperkalaemia  1  1/86 (1.16%) 
Hyperuricaemia  1  1/86 (1.16%) 
Hypoalbuminaemia  1  2/86 (2.33%) 
Hypocalcaemia  1  1/86 (1.16%) 
Hypokalaemia  1  3/86 (3.49%) 
Hyponatraemia  1  3/86 (3.49%) 
Increased appetite  1  1/86 (1.16%) 
Malnutrition  1  1/86 (1.16%) 
Pseudohyperkalaemia  1  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/86 (4.65%) 
Back pain  1  5/86 (5.81%) 
Bone pain  1  1/86 (1.16%) 
Joint effusion  1  1/86 (1.16%) 
Joint swelling  1  2/86 (2.33%) 
Muscle spasms  1  4/86 (4.65%) 
Muscular weakness  1  2/86 (2.33%) 
Musculoskeletal chest pain  1  3/86 (3.49%) 
Musculoskeletal discomfort  1  1/86 (1.16%) 
Musculoskeletal pain  1  1/86 (1.16%) 
Musculoskeletal stiffness  1  1/86 (1.16%) 
Myalgia  1  2/86 (2.33%) 
Pain in extremity  1  4/86 (4.65%) 
Polymyositis  1  1/86 (1.16%) 
Spondylitis  1  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Fibroma  1  1/86 (1.16%) 
Melanocytic naevus  1  1/86 (1.16%) 
Nervous system disorders   
Ageusia  1  1/86 (1.16%) 
Dizziness  1  7/86 (8.14%) 
Dysarthria  1  1/86 (1.16%) 
Dyskinesia  1  1/86 (1.16%) 
Headache  1  16/86 (18.60%) 
Hemiparesis  1  1/86 (1.16%) 
Hypoaesthesia  1  1/86 (1.16%) 
Lethargy  1  4/86 (4.65%) 
Migraine  1  1/86 (1.16%) 
Neuralgia  1  1/86 (1.16%) 
Paraesthesia  1  5/86 (5.81%) 
Peripheral sensory neuropathy  1  2/86 (2.33%) 
Sciatica  1  1/86 (1.16%) 
Somnolence  1  1/86 (1.16%) 
Syncope  1  1/86 (1.16%) 
Tremor  1  3/86 (3.49%) 
Psychiatric disorders   
Agitation  1  2/86 (2.33%) 
Anxiety  1  4/86 (4.65%) 
Confusional state  1  2/86 (2.33%) 
Depression  1  2/86 (2.33%) 
Insomnia  1  9/86 (10.47%) 
Mood altered  1  1/86 (1.16%) 
Neurosis  1  1/86 (1.16%) 
Stress  1  1/86 (1.16%) 
Renal and urinary disorders   
Dysuria  1  2/86 (2.33%) 
Haematuria  1  1/86 (1.16%) 
Nocturia  1  1/86 (1.16%) 
Pollakiuria  1  2/86 (2.33%) 
Renal failure  1  2/86 (2.33%) 
Reproductive system and breast disorders   
Balanitis  1  1/86 (1.16%) 
Breast oedema  1  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/86 (1.16%) 
Cough  1  14/86 (16.28%) 
Dysphonia  1  2/86 (2.33%) 
Dyspnoea  1  14/86 (16.28%) 
Dyspnoea exertional  1  2/86 (2.33%) 
Epistaxis  1  1/86 (1.16%) 
Haemoptysis  1  1/86 (1.16%) 
Hypoxia  1  2/86 (2.33%) 
Oropharyngeal pain  1  3/86 (3.49%) 
Orthopnoea  1  1/86 (1.16%) 
Pleural effusion  1  1/86 (1.16%) 
Pleurisy  1  1/86 (1.16%) 
Productive cough  1  2/86 (2.33%) 
Pulmonary hypertension  1  1/86 (1.16%) 
Respiratory disorder  1  1/86 (1.16%) 
Respiratory failure  1  1/86 (1.16%) 
Respiratory tract congestion  1  1/86 (1.16%) 
Rhinorrhoea  1  1/86 (1.16%) 
Sinusitis noninfective  1  1/86 (1.16%) 
Tachypnoea  1  1/86 (1.16%) 
Throat tightness  1  1/86 (1.16%) 
Tonsillar disorder  1  1/86 (1.16%) 
Vasomotor rhinitis  1  1/86 (1.16%) 
Skin and subcutaneous tissue disorders   
Blister  1  1/86 (1.16%) 
Dermatitis allergic  1  1/86 (1.16%) 
Dry skin  1  3/86 (3.49%) 
Ecchymosis  1  1/86 (1.16%) 
Eczema  1  1/86 (1.16%) 
Erythema  1  9/86 (10.47%) 
Hyperhidrosis  1  3/86 (3.49%) 
Night sweats  1  12/86 (13.95%) 
Petechiae  1  3/86 (3.49%) 
Pityriasis rosea  1  1/86 (1.16%) 
Pruritus  1  11/86 (12.79%) 
Pruritus generalised  1  1/86 (1.16%) 
Rash  1  8/86 (9.30%) 
Rash generalised  1  1/86 (1.16%) 
Rash maculo-papular  1  1/86 (1.16%) 
Skin reaction  1  2/86 (2.33%) 
Urticaria  1  3/86 (3.49%) 
Vascular disorders   
Haematoma  1  1/86 (1.16%) 
Hypertension  1  4/86 (4.65%) 
Hypotension  1  6/86 (6.98%) 
Orthostatic hypotension  1  3/86 (3.49%) 
Phlebitis  1  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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 an independent multi-investigator publication (in which the PI can participate) 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: 1-800-745-4447
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00328198     History of Changes
Other Study ID Numbers: CAM203
2005-005074-69 ( EudraCT Number )
First Submitted: May 18, 2006
First Posted: May 19, 2006
Results First Submitted: June 25, 2012
Results First Posted: August 10, 2012
Last Update Posted: March 13, 2014