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A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

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ClinicalTrials.gov Identifier: NCT00924443
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Bioenvision
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Intervention Drug: clofarabine
Enrollment 69
Recruitment Details Participants were entered into the study between 14 Jun 2004 and 14 Nov 2005. Participants were recruited from 14 of a total of 17 registered centres located in the United Kingdom (UK), Ireland and Italy. Relapse and survival data follow-up cut-off was extended to 23 May 2008.
Pre-assignment Details A total of 69 participants were screened and enrolled. A total of 66 participants received study drug and are included in the reported results.
Arm/Group Title Clofarabine
Hide Arm/Group Description Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
Period Title: Overall Study
Started 69
Full Analysis Set (Received Study Drug) 66
Completed 66
Not Completed 3
Reason Not Completed
Physician Decision             2
Protocol Violation             1
Arm/Group Title Clofarabine
Hide Arm/Group Description Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
Baseline Characteristics provided for Full Analysis Set (FAS) population, defined as all participants with a confirmed diagnosis of AML who received at least one dose of clofarabine
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants
71.5  (4.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
33
  50.0%
Male
33
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
66
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
Ireland 3
Italy 8
United Kingdom 55
Cytogenetics (1998)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
Favourable 0
Intermediate 43
Adverse 19
Missing/Unknown 4
[1]
Measure Description: Diagnostic criteria of Grimwade for younger patients
Cytogenetics (2001)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
Favourable 0
Intermediate 48
Adverse 14
Missing/Unknown 4
[1]
Measure Description: Diagnostic criteria of Grimwade for older patients
Type of Acute Myeloid Leukemia (AML)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
De Novo 48
Secondary 16
Missing/Unknown 2
White Blood Cell Count (10^9/L)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
<25 57
25-99.9 6
>=100 3
Glomerular Filtration Rate (mL/min/1.73m^2)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
<=50 15
>50 51
Number of Co-morbidities  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
0 17
1 23
>1 26
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
100% 8
90% 13
80% 24
70% 9
60% 2
50% 5
20% 2
Missing 3
[1]
Measure Description:

Karnofsky performance scale is used by doctors to classify patient's functional impairment level. The lower the number the higher the impairment in typical daily activities by the disease.

Typical classification examples: 100% normal with no evidence of disease, 90% able to carry on normal activity with minor signs of illness, 80% normal activity but requiring effort, 70% able to care for self but unable to work or carry on other normal activities, 60% able to care for most needs but requires occasional assistance, 50% considerable assistance and frequent medical care required, etc..

1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.

ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Time Frame At month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48
(36 to 61)
2.Secondary Outcome
Title Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Hide Description

Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.

Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Time Frame At month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Complete response
21
(12 to 33)
Complete with incomplete blood count recovery
23
(13 to 35)
Partial response
5
(1 to 13)
3.Secondary Outcome
Title Duration of Overall Response
Hide Description Duration was calculated by Kaplan-Meier estimates
Time Frame From 20 months up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: days
62
(42 to 153)
4.Secondary Outcome
Title Overall Survival
Hide Description Calculated by Kaplan-Meier estimates
Time Frame From 20 months up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Participants Analyzed 66
Median (95% Confidence Interval)
Unit of Measure: days
173
(90 to 295)
5.Secondary Outcome
Title Duration of Complete Remission
Hide Description Duration was calculated by Kaplan- Meier estimates
Time Frame From 20 months up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: days
63
(43 to 168)
Time Frame From first dose until 30 days after study completion (20 months)
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 Clofarabine
Hide Arm/Group Description Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
All-Cause Mortality
Clofarabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clofarabine
Affected / at Risk (%)
Total   40/66 (60.61%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/66 (1.52%) 
FEBRILE NEUTROPENIA  1  1/66 (1.52%) 
NEUTROPENIA  1  1/66 (1.52%) 
PANCYTOPENIA  1  1/66 (1.52%) 
PLATELET DISORDER  1  1/66 (1.52%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  4/66 (6.06%) 
PERICARDIAL EFFUSION  1  1/66 (1.52%) 
Endocrine disorders   
HYPOPITUITARISM  1  1/66 (1.52%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/66 (1.52%) 
DIARRHOEA  1  2/66 (3.03%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/66 (1.52%) 
ILEUS PARALYTIC  1  1/66 (1.52%) 
VOMITING  1  2/66 (3.03%) 
General disorders   
DISEASE PROGRESSION  1  1/66 (1.52%) 
OEDEMA  1  1/66 (1.52%) 
PYREXIA  1  2/66 (3.03%) 
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/66 (1.52%) 
Infections and infestations   
BACTERAEMIA  1  1/66 (1.52%) 
BRONCHOPNEUMONIA  1  1/66 (1.52%) 
CATHETER RELATED INFECTION  1  1/66 (1.52%) 
CENTRAL LINE INFECTION  1  1/66 (1.52%) 
ENCEPHALITIS HERPES  1  1/66 (1.52%) 
INFECTION  1  2/66 (3.03%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/66 (3.03%) 
NEUTROPENIC SEPSIS  1  17/66 (25.76%) 
PNEUMONIA  1  4/66 (6.06%) 
RESPIRATORY TRACT INFECTION FUNGAL  1  1/66 (1.52%) 
SEPSIS  1  5/66 (7.58%) 
Injury, poisoning and procedural complications   
ACCIDENTAL OVERDOSE  1  1/66 (1.52%) 
FALL  1  1/66 (1.52%) 
Investigations   
BLOOD BILIRUBIN INCREASED  1  1/66 (1.52%) 
BLOOD CREATININE INCREASED  1  1/66 (1.52%) 
HAEMOGLOBIN DECREASED  1  1/66 (1.52%) 
HEPATIC ENZYME INCREASED  1  1/66 (1.52%) 
URINE OUTPUT DECREASED  1  2/66 (3.03%) 
Metabolism and nutrition disorders   
HYPOKALAEMIA  1  2/66 (3.03%) 
HYPOMAGNESAEMIA  1  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  1/66 (1.52%) 
PAIN IN EXTREMITY  1  1/66 (1.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PITUITARY TUMOUR  1  1/66 (1.52%) 
Nervous system disorders   
CEREBRAL HAEMORRHAGE  1  1/66 (1.52%) 
CEREBROVASCULAR ACCIDENT  1  2/66 (3.03%) 
HAEMORRHAGE INTRACRANIAL  1  3/66 (4.55%) 
HEADACHE  1  1/66 (1.52%) 
SYNCOPE  1  1/66 (1.52%) 
UNRESPONSIVE TO PAIN STIMULI  1  1/66 (1.52%) 
Renal and urinary disorders   
NEPHROTIC SYNDROME  1  1/66 (1.52%) 
RENAL FAILURE ACUTE  1  7/66 (10.61%) 
RENAL IMPAIRMENT  1  2/66 (3.03%) 
RENAL INSUFFICIENCY  1  5/66 (7.58%) 
Skin and subcutaneous tissue disorders   
RASH  1  2/66 (3.03%) 
SKIN DESQUAMATION  1  1/66 (1.52%) 
Vascular disorders   
HYPOTENSION  1  1/66 (1.52%) 
THROMBOSIS  1  1/66 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clofarabine
Affected / at Risk (%)
Total   66/66 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  22/66 (33.33%) 
COAGULOPATHY  1  1/66 (1.52%) 
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/66 (1.52%) 
FEBRILE NEUTROPENIA  1  4/66 (6.06%) 
HAEMOLYTIC ANAEMIA  1  1/66 (1.52%) 
LYMPHOPENIA  1  2/66 (3.03%) 
NEUTROPENIA  1  19/66 (28.79%) 
PANCYTOPENIA  1  1/66 (1.52%) 
SPLENOMEGALY  1  1/66 (1.52%) 
THROMBOCYTOPENIA  1  32/66 (48.48%) 
Cardiac disorders   
ARRHYTHMIA SUPRAVENTRICULAR  1  2/66 (3.03%) 
ATRIAL FIBRILLATION  1  4/66 (6.06%) 
PALPITATIONS  1  1/66 (1.52%) 
SUPRAVENTRICULAR EXTRASYSTOLES  1  1/66 (1.52%) 
TACHYCARDIA  1  1/66 (1.52%) 
Ear and labyrinth disorders   
VERTIGO  1  1/66 (1.52%) 
Endocrine disorders   
ADRENAL INSUFFICIENCY  1  1/66 (1.52%) 
HYPOTHALAMO-PITUITARY DISORDERS  1  1/66 (1.52%) 
HYPOTHYROIDISM  1  1/66 (1.52%) 
Eye disorders   
EYE PAIN  1  1/66 (1.52%) 
EYE REDNESS  1  1/66 (1.52%) 
HETEROPHORIA  1  1/66 (1.52%) 
KERATOCONJUNCTIVITIS SICCA  1  2/66 (3.03%) 
LACRIMATION INCREASED  1  1/66 (1.52%) 
VISION BLURRED  1  2/66 (3.03%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/66 (1.52%) 
ABDOMINAL PAIN  1  13/66 (19.70%) 
CHEILITIS  1  1/66 (1.52%) 
CONSTIPATION  1  27/66 (40.91%) 
DIARRHOEA  1  40/66 (60.61%) 
DRY MOUTH  1  6/66 (9.09%) 
DYSPEPSIA  1  5/66 (7.58%) 
DYSPHAGIA  1  1/66 (1.52%) 
ERUCTATION  1  1/66 (1.52%) 
FAECALOMA  1  1/66 (1.52%) 
FLATULENCE  1  1/66 (1.52%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/66 (1.52%) 
GINGIVAL PAIN  1  1/66 (1.52%) 
GLOSSODYNIA  1  1/66 (1.52%) 
HAEMATEMESIS  1  1/66 (1.52%) 
HAEMORRHOIDAL HAEMORRHAGE  1  1/66 (1.52%) 
ILEUS PARALYTIC  1  1/66 (1.52%) 
LOOSE STOOLS  1  2/66 (3.03%) 
MELAENA  1  2/66 (3.03%) 
MOUTH ULCERATION  1  6/66 (9.09%) 
NAUSEA  1  44/66 (66.67%) 
OESOPHAGEAL ULCER  1  1/66 (1.52%) 
ORAL MUCOSAL BLISTERING  1  1/66 (1.52%) 
ORAL MUCOSAL PETECHIAE  1  1/66 (1.52%) 
ORAL PAIN  1  5/66 (7.58%) 
RECTAL PROLAPSE  1  1/66 (1.52%) 
STOMATITIS  1  5/66 (7.58%) 
SWOLLEN TONGUE  1  1/66 (1.52%) 
TONGUE BLISTERING  1  1/66 (1.52%) 
TONGUE COATED  1  3/66 (4.55%) 
TONGUE ULCERATION  1  1/66 (1.52%) 
TOOTHACHE  1  2/66 (3.03%) 
VOMITING  1  37/66 (56.06%) 
General disorders   
ASTHENIA  1  7/66 (10.61%) 
CATHETER RELATED COMPLICATION  1  14/66 (21.21%) 
CATHETER SITE INFLAMMATION  1  1/66 (1.52%) 
CHEST DISCOMFORT  1  1/66 (1.52%) 
CHEST PAIN  1  11/66 (16.67%) 
FATIGUE  1  16/66 (24.24%) 
GAIT ABNORMAL  1  2/66 (3.03%) 
GENERALISED OEDEMA  1  1/66 (1.52%) 
INFLUENZA LIKE ILLNESS  1  2/66 (3.03%) 
LOCALISED OEDEMA  1  1/66 (1.52%) 
MASS  1  1/66 (1.52%) 
MUCOSAL INFLAMMATION  1  2/66 (3.03%) 
OEDEMA  1  2/66 (3.03%) 
OEDEMA PERIPHERAL  1  12/66 (18.18%) 
PAIN  1  3/66 (4.55%) 
PITTING OEDEMA  1  1/66 (1.52%) 
PYREXIA  1  24/66 (36.36%) 
RIGORS  1  7/66 (10.61%) 
TENDERNESS  1  1/66 (1.52%) 
Hepatobiliary disorders   
CHOLELITHIASIS  1  1/66 (1.52%) 
HEPATOTOXICITY  1  1/66 (1.52%) 
HYPERBILIRUBINAEMIA  1  4/66 (6.06%) 
Immune system disorders   
HYPERSENSITIVITY  1  2/66 (3.03%) 
Infections and infestations   
ANAL INFECTION  1  1/66 (1.52%) 
BACTERIAL INFECTION  1  2/66 (3.03%) 
BACTERIAL SEPSIS  1  2/66 (3.03%) 
CELLULITIS  1  7/66 (10.61%) 
CENTRAL LINE INFECTION  1  11/66 (16.67%) 
CLOSTRIDIAL INFECTION  1  1/66 (1.52%) 
CLOSTRIDIUM COLITIS  1  1/66 (1.52%) 
FUNGAL INFECTION  1  1/66 (1.52%) 
GASTROINTESTINAL CANDIDIASIS  1  1/66 (1.52%) 
GENITAL INFECTION FEMALE  1  1/66 (1.52%) 
HERPES SIMPLEX  1  3/66 (4.55%) 
HERPES VIRUS INFECTION  1  1/66 (1.52%) 
INFECTION  1  9/66 (13.64%) 
LOWER RESPIRATORY TRACT INFECTION  1  4/66 (6.06%) 
NASOPHARYNGITIS  1  1/66 (1.52%) 
NEUTROPENIC INFECTION  1  2/66 (3.03%) 
NEUTROPENIC SEPSIS  1  3/66 (4.55%) 
ORAL CANDIDIASIS  1  1/66 (1.52%) 
PHARYNGITIS  1  1/66 (1.52%) 
PNEUMONIA  1  3/66 (4.55%) 
PNEUMONIA FUNGAL  1  2/66 (3.03%) 
RHINITIS  1  1/66 (1.52%) 
SEPSIS  1  5/66 (7.58%) 
URINARY TRACT INFECTION  1  2/66 (3.03%) 
VANCOMYCIN-RESISTANT ENTEROCOCCAL INFECTION  1  1/66 (1.52%) 
VIRAL INFECTION  1  2/66 (3.03%) 
Injury, poisoning and procedural complications   
BLISTER  1  1/66 (1.52%) 
CONTUSION  1  4/66 (6.06%) 
FALL  1  3/66 (4.55%) 
MEDICAL DEVICE DISCOMFORT  1  1/66 (1.52%) 
TRANSFUSION REACTION  1  3/66 (4.55%) 
Investigations   
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  1/66 (1.52%) 
ALANINE AMINOTRANSFERASE INCREASED  1  21/66 (31.82%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  15/66 (22.73%) 
BACTERIA BLOOD IDENTIFIED  1  1/66 (1.52%) 
BACTERIA STOOL IDENTIFIED  1  1/66 (1.52%) 
BLOOD ALBUMIN DECREASED  1  2/66 (3.03%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  5/66 (7.58%) 
BLOOD BICARBONATE DECREASED  1  4/66 (6.06%) 
BLOOD BILIRUBIN INCREASED  1  6/66 (9.09%) 
BLOOD CALCIUM DECREASED  1  3/66 (4.55%) 
BLOOD CREATININE  1  1/66 (1.52%) 
BLOOD CREATININE ABNORMAL  1  2/66 (3.03%) 
BLOOD CREATININE DECREASED  1  1/66 (1.52%) 
BLOOD CREATININE INCREASED  1  8/66 (12.12%) 
BLOOD LACTATE DEHYDROGENASE INCREASED  1  9/66 (13.64%) 
BLOOD MAGNESIUM  1  1/66 (1.52%) 
BLOOD MAGNESIUM DECREASED  1  2/66 (3.03%) 
BLOOD MAGNESIUM INCREASED  1  2/66 (3.03%) 
BLOOD PHOSPHORUS DECREASED  1  3/66 (4.55%) 
BLOOD PHOSPHORUS INCREASED  1  1/66 (1.52%) 
BLOOD POTASSIUM DECREASED  1  11/66 (16.67%) 
BLOOD PRESSURE DECREASED  1  1/66 (1.52%) 
BLOOD SODIUM DECREASED  1  3/66 (4.55%) 
BLOOD SODIUM INCREASED  1  1/66 (1.52%) 
BLOOD UREA DECREASED  1  1/66 (1.52%) 
BLOOD UREA INCREASED  1  10/66 (15.15%) 
BODY TEMPERATURE INCREASED  1  1/66 (1.52%) 
CARDIAC MURMUR  1  1/66 (1.52%) 
HAEMOGLOBIN DECREASED  1  6/66 (9.09%) 
HEART RATE IRREGULAR  1  1/66 (1.52%) 
HEPATIC ENZYME INCREASED  1  1/66 (1.52%) 
LIVER FUNCTION TEST ABNORMAL  1  3/66 (4.55%) 
NEUTROPHIL COUNT DECREASED  1  1/66 (1.52%) 
PLATELET COUNT DECREASED  1  6/66 (9.09%) 
PROTEIN TOTAL DECREASED  1  2/66 (3.03%) 
PROTHROMBIN TIME PROLONGED  1  1/66 (1.52%) 
TROPONIN T INCREASED  1  1/66 (1.52%) 
URINE OUTPUT DECREASED  1  1/66 (1.52%) 
WEIGHT DECREASED  1  3/66 (4.55%) 
WEIGHT INCREASED  1  4/66 (6.06%) 
WHITE BLOOD CELL COUNT DECREASED  1  2/66 (3.03%) 
Metabolism and nutrition disorders   
ACIDOSIS  1  2/66 (3.03%) 
ANOREXIA  1  10/66 (15.15%) 
DECREASED APPETITE  1  17/66 (25.76%) 
DEHYDRATION  1  5/66 (7.58%) 
ELECTROLYTE IMBALANCE  1  2/66 (3.03%) 
FLUID OVERLOAD  1  2/66 (3.03%) 
GOUT  1  2/66 (3.03%) 
HYPERGLYCAEMIA  1  4/66 (6.06%) 
HYPERNATRAEMIA  1  1/66 (1.52%) 
HYPERPHOSPHATAEMIA  1  1/66 (1.52%) 
HYPOALBUMINAEMIA  1  6/66 (9.09%) 
HYPOCALCAEMIA  1  11/66 (16.67%) 
HYPOKALAEMIA  1  23/66 (34.85%) 
HYPOMAGNESAEMIA  1  4/66 (6.06%) 
HYPONATRAEMIA  1  3/66 (4.55%) 
HYPOPHOSPHATAEMIA  1  3/66 (4.55%) 
METABOLIC ACIDOSIS  1  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  7/66 (10.61%) 
ARTHRITIS  1  1/66 (1.52%) 
BACK PAIN  1  6/66 (9.09%) 
BUTTOCK PAIN  1  1/66 (1.52%) 
JOINT STIFFNESS  1  1/66 (1.52%) 
JOINT SWELLING  1  2/66 (3.03%) 
MUSCLE CRAMP  1  1/66 (1.52%) 
MUSCULOSKELETAL PAIN  1  1/66 (1.52%) 
MYALGIA  1  5/66 (7.58%) 
NECK PAIN  1  1/66 (1.52%) 
PAIN IN EXTREMITY  1  7/66 (10.61%) 
Nervous system disorders   
BURNING SENSATION  1  2/66 (3.03%) 
CENTRAL NERVOUS SYSTEM INFLAMMATION  1  1/66 (1.52%) 
CEREBRAL ISCHAEMIA  1  1/66 (1.52%) 
DEPRESSED LEVEL OF CONSCIOUSNESS  1  1/66 (1.52%) 
DIZZINESS  1  11/66 (16.67%) 
DYSARTHRIA  1  1/66 (1.52%) 
DYSGEUSIA  1  3/66 (4.55%) 
HAEMORRHAGE INTRACRANIAL  1  1/66 (1.52%) 
HEADACHE  1  14/66 (21.21%) 
HYPERAESTHESIA  1  1/66 (1.52%) 
HYPOAESTHESIA  1  1/66 (1.52%) 
LETHARGY  1  7/66 (10.61%) 
PARAESTHESIA  1  1/66 (1.52%) 
POLYNEUROPATHY  1  1/66 (1.52%) 
RESTLESS LEGS SYNDROME  1  1/66 (1.52%) 
SOMNOLENCE  1  1/66 (1.52%) 
SPEECH DISORDER  1  1/66 (1.52%) 
SYNCOPE  1  3/66 (4.55%) 
SYNCOPE VASOVAGAL  1  3/66 (4.55%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/66 (1.52%) 
Psychiatric disorders   
AGITATION  1  5/66 (7.58%) 
ANXIETY  1  7/66 (10.61%) 
CONFUSIONAL STATE  1  9/66 (13.64%) 
DEPRESSED MOOD  1  1/66 (1.52%) 
DEPRESSION  1  2/66 (3.03%) 
DISORIENTATION  1  1/66 (1.52%) 
EMOTIONAL DISTRESS  1  1/66 (1.52%) 
HALLUCINATION  1  6/66 (9.09%) 
INSOMNIA  1  9/66 (13.64%) 
PANIC ATTACK  1  1/66 (1.52%) 
PSYCHIATRIC SYMPTOM  1  1/66 (1.52%) 
SLEEP DISORDER  1  1/66 (1.52%) 
Renal and urinary disorders   
DYSURIA  1  2/66 (3.03%) 
HAEMATURIA  1  5/66 (7.58%) 
OLIGURIA  1  1/66 (1.52%) 
POLLAKIURIA  1  1/66 (1.52%) 
RENAL COLIC  1  1/66 (1.52%) 
RENAL FAILURE ACUTE  1  3/66 (4.55%) 
RENAL IMPAIRMENT  1  7/66 (10.61%) 
RENAL INSUFFICIENCY  1  2/66 (3.03%) 
RENAL TUBULAR DISORDER  1  1/66 (1.52%) 
URINARY INCONTINENCE  1  4/66 (6.06%) 
Reproductive system and breast disorders   
BALANITIS  1  1/66 (1.52%) 
PENIS DISORDER  1  1/66 (1.52%) 
VAGINAL HAEMORRHAGE  1  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders   
APNOEIC ATTACK  1  1/66 (1.52%) 
CAPILLARY LEAK SYNDROME  1  2/66 (3.03%) 
COUGH  1  13/66 (19.70%) 
CRACKLES LUNG  1  2/66 (3.03%) 
DYSPNOEA  1  14/66 (21.21%) 
DYSPNOEA EXERTIONAL  1  1/66 (1.52%) 
EPISTAXIS  1  8/66 (12.12%) 
HAEMOPTYSIS  1  1/66 (1.52%) 
HYPOXIA  1  2/66 (3.03%) 
INCREASED UPPER AIRWAY SECRETION  1  1/66 (1.52%) 
LUNG CREPITATION  1  6/66 (9.09%) 
LUNG INFILTRATION  1  1/66 (1.52%) 
NASAL CONGESTION  1  1/66 (1.52%) 
PHARYNGOLARYNGEAL PAIN  1  8/66 (12.12%) 
PLEURAL EFFUSION  1  6/66 (9.09%) 
PLEURITIC PAIN  1  3/66 (4.55%) 
PNEUMOTHORAX  1  1/66 (1.52%) 
PRODUCTIVE COUGH  1  1/66 (1.52%) 
PULMONARY OEDEMA  1  2/66 (3.03%) 
RESPIRATORY DISORDER  1  1/66 (1.52%) 
RHINORRHOEA  1  2/66 (3.03%) 
WHEEZING  1  5/66 (7.58%) 
Skin and subcutaneous tissue disorders   
ALOPECIA  1  1/66 (1.52%) 
DECUBITUS ULCER  1  3/66 (4.55%) 
DERMATITIS ALLERGIC  1  1/66 (1.52%) 
DERMATITIS EXFOLIATIVE  1  1/66 (1.52%) 
DRY SKIN  1  1/66 (1.52%) 
ECCHYMOSIS  1  1/66 (1.52%) 
ERYTHEMA  1  7/66 (10.61%) 
HYPERHIDROSIS  1  3/66 (4.55%) 
LOCALISED SKIN REACTION  1  1/66 (1.52%) 
NIGHT SWEATS  1  1/66 (1.52%) 
PALMAR ERYTHEMA  1  1/66 (1.52%) 
PRURITUS  1  7/66 (10.61%) 
PRURITUS GENERALISED  1  1/66 (1.52%) 
PURPURA  1  1/66 (1.52%) 
RASH  1  29/66 (43.94%) 
RASH ERYTHEMATOUS  1  3/66 (4.55%) 
RASH GENERALISED  1  1/66 (1.52%) 
RASH MACULAR  1  1/66 (1.52%) 
RASH MACULO-PAPULAR  1  1/66 (1.52%) 
RASH PAPULAR  1  1/66 (1.52%) 
RASH PRURITIC  1  3/66 (4.55%) 
SWELLING FACE  1  1/66 (1.52%) 
Social circumstances   
INADEQUATE DIET  1  1/66 (1.52%) 
Vascular disorders   
FLUSHING  1  2/66 (3.03%) 
HAEMORRHAGE  1  2/66 (3.03%) 
HYPERTENSION  1  7/66 (10.61%) 
HYPOTENSION  1  11/66 (16.67%) 
ORTHOSTATIC HYPOTENSION  1  1/66 (1.52%) 
PETECHIAE  1  5/66 (7.58%) 
VENOUS THROMBOSIS LIMB  1  1/66 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
There IS an agreement between the Principal Investigator (PI) 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 sponsor publishes or 18 months after study completion. PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00924443     History of Changes
Other Study ID Numbers: BIOV-121
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: March 20, 2015
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015