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A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

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ClinicalTrials.gov Identifier: NCT00373529
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : March 24, 2011
Last Update Posted : April 14, 2014
Sponsor:
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
Conditions Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Intervention Drug: clofarabine
Enrollment 116
Recruitment Details  
Pre-assignment Details 129 patients were screened and 116 participants enrolled/treated at 20 sites.
Arm/Group Title Clofarabine
Hide Arm/Group Description Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Period Title: Overall Study
Started 116
Full Analysis Set 112 [1]
Completed 8 [2]
Not Completed 108
Reason Not Completed
Physician Decision             19
Withdrawal by Subject             7
Adverse Event             7
Treatment failure             36
Disease recurrence             10
Death             16
Need for treatment prohibited by study             1
Not specified             8
Failed independent confirmation of AML             3
Consent violation             1
[1]
3 Failed Independent Confirmation of AML; 1 consent violation
[2]
Completed: initiated full 6 cycles of treatment. Not Completed: initiated <6 cycles of treatment
Arm/Group Title Clofarabine
Hide Arm/Group Description Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants
71.4  (5.92)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 112 participants
71.0
(60 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
60
  53.6%
Male
52
  46.4%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
American Indian or Alaska Native 1
Asian 4
Native Hawaiian or Other Pacific Islander 0
Black or African American 7
White 98
Other 2
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
Hispanic or Latino 4
Not Hispanic or Latino 108
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 112 participants
166.50  (10.366)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 112 participants
78.45  (18.191)
Age at Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
>= 70 years 69
< 70 years 43
[1]
Measure Description: Being 70 years old or older is considered an adverse prognostic factor.
Antecedent Hematologic Disorder   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
Yes 41
No 67
Not reported 4
[1]
Measure Description: The most common risk factor for acute myelogenous leukemia (AML) is the presence of an antecedent hematologic disorder.
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
ECOG 5 0
ECOG 4 0
ECOG 3 0
ECOG 2 25
ECOG 1 66
ECOG 0 21
[1]
Measure Description: Another prognostic factor. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is a scale ranging from 0-5, with 0=fully active, 1=capable of light work, 2=no work but all self-care, 3=limited self-care, 4=completely disabled, 5=dead.
Karyotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
Intermediate 46
Unfavorable 62
Favorable 0
Not reported 4
[1]
Measure Description: A favorable cytogenetic karyotype is associated with a positive prognostic outcome; an unfavorable cytogenetic karyotype is associated with a negative prognostic outcome. An intermediate karyotype is typically associated with a better outcome than a favorable karyotype, but also associated with a worse outcome compared to a favorable karyotype.
Participants Summarized by Number of Adverse Prognostic Factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
0 Adverse Prognostic Factors 0
1 Adverse Prognostic Factor 25
2 Adverse Prognostic Factors 45
3 Adverse Prognostic Factors 40
4 Adverse Prognostic Factors 2
[1]
Measure Description: Participant counts by the number of adverse prognostic factors, which include age >= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = intermediate or unfavorable.
Participants Summarized by Number of Adverse Prognostic Factors Excluding Intermediate Karyotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
0 Adverse Prognostic Factors 7
1 Adverse Prognostic Factor 42
2 Adverse Prognostic Factors 35
3 Adverse Prognostic Factors 27
4 Adverse Prognostic Factors 1
[1]
Measure Description: Participant counts by the number of adverse prognostic factors, which include age >= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = unfavorable.
Secondary acute myeloid leukemia (AML) at baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
Yes 11
No 101
[1]
Measure Description: The diagnosis of secondary AML is based upon investigator judgment regarding prior ionizing radiation and/or chemotherapy.
1.Primary Outcome
Title Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
Hide Description Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
Time Frame approximately Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
Overall Remission (OR=CR+CRp) 45.5
Complete Remission (CR) 37.5
Complete Remission w/o platelet recovery (CRp) 8.0
Partial Remission (PR) 3.6
Treatment Failure (TF) 50.9
2.Secondary Outcome
Title Kaplan Meier Estimate for Duration of Remission (DOR)
Hide Description DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) of participants who achieved remission.
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: weeks
55.6
(33.1 to 82.9)
3.Secondary Outcome
Title Kaplan Meier Estimate for Disease-free Survival (DFS)
Hide Description DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) of participants who achieved remission.
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: weeks
43.8
(27.6 to 60.7)
4.Secondary Outcome
Title Kaplan Meier Estimates for Overall Survival (OS)
Hide Description OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 112
Median (95% Confidence Interval)
Unit of Measure: weeks
40.7
(28.3 to 52.0)
5.Secondary Outcome
Title Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods
Hide Description

Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline.

NCI Common Terminology Criteria for Severity:

Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: participants
Treatment-emergent AEs (TEAE) 112
Treatment-emergent AEs related to study drug 108
Treatment-emergent serious AEs 76
Treatment-emergent serious AEs related to drug 41
Discontinued due to AEs 7
Died w/i treatment period-w/i 45 days of last dose 22
Died due to drug-related AEs 4
Died within 30 days of first dose 11
Died w/i 30 days of first dose due to related AEs 3
Grade 1: maximum severity rating for any TEAE 2
Grade 2: maximum severity rating for any TEAE 6
Grade 3: maximum severity rating for any TEAE 46
Grade 4: maximum severity rating for any TEAE 34
Grade 5: maximum severity rating for any TEAE 24
6.Secondary Outcome
Title Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)
Hide Description Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
Time Frame up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
9.8
7.Other Pre-specified Outcome
Title Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors
Hide Description The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.
Time Frame approximately Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor
Arm/Group Title Clofarabine
Hide Arm/Group Description:
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: participants
Age >=70 (n=69) 27
Age <70 (n=43) 24
Antecedent hematologic disorder - Yes (n=41) 21
Antecedent hematologic disorder - No (n=67) 29
Antecedent hematologic disorder-Not reported (n=4) 1
ECOG Performance Status = 0-1 (n=87) 43
ECOG Performance Status = 2 (n=25) 8
Karyotype = Intermediate (n=46) 25
Karyotype = Unfavorable (n=62) 26
Karyotype = Not Reported (n=4) 0
Time Frame Up to 2 years.
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 Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
All-Cause Mortality
Clofarabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clofarabine
Affected / at Risk (%)
Total   76/112 (67.86%) 
Blood and lymphatic system disorders   
Anaemia  1  1/112 (0.89%) 
Bone marrow failure  1  1/112 (0.89%) 
Disseminated intravascular coagulation  1  2/112 (1.79%) 
Febrile neutropenia  1  28/112 (25.00%) 
Neutropenia  1  2/112 (1.79%) 
Thrombocytopenia  1  2/112 (1.79%) 
Cardiac disorders   
Acute myocardial infarction  1  1/112 (0.89%) 
Atrial fibrillation  1  7/112 (6.25%) 
Cardiac failure congestive  1  3/112 (2.68%) 
Cardio-respiratory arrest  1  1/112 (0.89%) 
Cardiomyopathy  1  1/112 (0.89%) 
Myocardial infarction  1  1/112 (0.89%) 
Sinus tachycardia  1  1/112 (0.89%) 
Tachycardia  1  1/112 (0.89%) 
Gastrointestinal disorders   
Abdominal pain  1  1/112 (0.89%) 
Diarrhoea  1  3/112 (2.68%) 
Gastrointestinal haemorrhage  1  4/112 (3.57%) 
Haematemesis  1  1/112 (0.89%) 
Haematochezia  1  1/112 (0.89%) 
Ileus  1  1/112 (0.89%) 
Melaena  1  1/112 (0.89%) 
Mouth haemorrhage  1  1/112 (0.89%) 
Nausea  1  1/112 (0.89%) 
Pancreatitis  1  1/112 (0.89%) 
Upper gastrointestinal haemorrhage  1  1/112 (0.89%) 
Vomiting  1  2/112 (1.79%) 
General disorders   
Asthenia  1  2/112 (1.79%) 
Fatigue  1  2/112 (1.79%) 
Multi-organ failure  1  2/112 (1.79%) 
Organ failure  1  1/112 (0.89%) 
Pyrexia  1  1/112 (0.89%) 
Infections and infestations   
Abscess intestinal  1  1/112 (0.89%) 
Bacteraemia  1  4/112 (3.57%) 
Bacterial infection  1  1/112 (0.89%) 
Bacterial sepsis  1  1/112 (0.89%) 
Bronchopulmonary aspergillosis  1  4/112 (3.57%) 
Candidiasis  1  1/112 (0.89%) 
Cellulitis  1  4/112 (3.57%) 
Clostridial infection  1  2/112 (1.79%) 
Clostridium difficile colitis  1  1/112 (0.89%) 
Device related infection  1  6/112 (5.36%) 
Device related sepsis  1  1/112 (0.89%) 
Diverticulitis  1  2/112 (1.79%) 
Enterococcal bacteraemia  1  3/112 (2.68%) 
Enterococcal sepsis  1  2/112 (1.79%) 
Escherichia bacteraemia  1  1/112 (0.89%) 
Herpes oesophagitis  1  1/112 (0.89%) 
Influenza  1  1/112 (0.89%) 
Lobar pneumonia  1  1/112 (0.89%) 
Oesophageal candidiasis  1  2/112 (1.79%) 
Oral bacterial infection  1  1/112 (0.89%) 
Oral candidiasis  1  1/112 (0.89%) 
Pneumocystis jiroveci pneumonia  1  1/112 (0.89%) 
Pneumonia  1  16/112 (14.29%) 
Pneumonia bacterial  1  1/112 (0.89%) 
Pneumonia chlamydial  1  1/112 (0.89%) 
Pneumonia cytomegaloviral  1  1/112 (0.89%) 
Pneumonia fungal  1  3/112 (2.68%) 
Pseudomonal sepsis  1  1/112 (0.89%) 
Pseudomonas infection  1  1/112 (0.89%) 
Respiratory moniliasis  1  1/112 (0.89%) 
Sepsis  1  6/112 (5.36%) 
Septic shock  1  2/112 (1.79%) 
Sinusitis  1  1/112 (0.89%) 
Sinusitis bacterial  1  1/112 (0.89%) 
Sinusitis fungal  1  1/112 (0.89%) 
Staphylococcal bacteraemia  1  3/112 (2.68%) 
Staphylococcal infection  1  3/112 (2.68%) 
Staphylococcal sepsis  1  1/112 (0.89%) 
Urinary tract infection  1  4/112 (3.57%) 
Urinary tract infection bacterial  1  1/112 (0.89%) 
Urinary tract infection enterococcal  1  1/112 (0.89%) 
Investigations   
Alanine aminotransferase increased  1  1/112 (0.89%) 
Aspartate aminotransferase increased  1  1/112 (0.89%) 
Bacterial test  1  1/112 (0.89%) 
Bacterial test positive  1  2/112 (1.79%) 
Blood creatine phosphokinase increased  1  1/112 (0.89%) 
Staphylococcus test positive  1  1/112 (0.89%) 
Troponin I increased  1  1/112 (0.89%) 
Metabolism and nutrition disorders   
Dehydration  1  5/112 (4.46%) 
Fluid overload  1  2/112 (1.79%) 
Hypocalcaemia  1  1/112 (0.89%) 
Hypokalaemia  1  2/112 (1.79%) 
Hypomagnesaemia  1  1/112 (0.89%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/112 (0.89%) 
Muscular weakness  1  2/112 (1.79%) 
Musculoskeletal pain  1  1/112 (0.89%) 
Neck pain  1  1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1  3/112 (2.68%) 
Malignant neoplasm progression  1  3/112 (2.68%) 
Nervous system disorders   
Cerebrovascular accident  1  1/112 (0.89%) 
Grand mal convulsion  1  1/112 (0.89%) 
Haemorrhage intracranial  1  1/112 (0.89%) 
Somnolence  1  2/112 (1.79%) 
Status epilepticus  1  1/112 (0.89%) 
Syncope  1  3/112 (2.68%) 
Transient ischaemic attack  1  1/112 (0.89%) 
Psychiatric disorders   
Agitation  1  1/112 (0.89%) 
Confusional state  1  1/112 (0.89%) 
Delirium  1  1/112 (0.89%) 
Hallucination  1  2/112 (1.79%) 
Renal and urinary disorders   
Haematuria  1  2/112 (1.79%) 
Renal failure  1  2/112 (1.79%) 
Renal failure acute  1  9/112 (8.04%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  2/112 (1.79%) 
Chronic obstructive pulmonary disease  1  1/112 (0.89%) 
Dyspnoea  1  3/112 (2.68%) 
Pulmonary alveolar haemorrhage  1  1/112 (0.89%) 
Pulmonary haemorrhage  1  1/112 (0.89%) 
Pulmonary oedema  1  3/112 (2.68%) 
Respiratory distress  1  3/112 (2.68%) 
Respiratory failure  1  4/112 (3.57%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/112 (0.89%) 
Vascular disorders   
Hypotension  1  2/112 (1.79%) 
Jugular vein thrombosis  1  1/112 (0.89%) 
Orthostatic hypotension  1  1/112 (0.89%) 
Peripheral arterial occlusive disease  1  1/112 (0.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clofarabine
Affected / at Risk (%)
Total   112/112 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  12/112 (10.71%) 
Coagulopathy  1  2/112 (1.79%) 
Disseminated intravascular coagulation  1  4/112 (3.57%) 
Eosinophilia  1  1/112 (0.89%) 
Febrile neutropenia  1  50/112 (44.64%) 
Hypergammaglobulinaemia  1  1/112 (0.89%) 
Hypocoagulable state  1  1/112 (0.89%) 
Hypoprothrombinaemia  1  1/112 (0.89%) 
Leukopenia  1  2/112 (1.79%) 
Lymph node calcification  1  1/112 (0.89%) 
Lymphadenopathy  1  5/112 (4.46%) 
Lymphocytic infiltration  1  1/112 (0.89%) 
Neutropenia  1  21/112 (18.75%) 
Pancytopenia  1  4/112 (3.57%) 
Platelet disorder  1  1/112 (0.89%) 
Splenic granuloma  1  1/112 (0.89%) 
Splenomegaly  1  2/112 (1.79%) 
Thrombocytopenia  1  18/112 (16.07%) 
White blood cell disorder  1  1/112 (0.89%) 
Cardiac disorders   
Acute myocardial infarction  1  1/112 (0.89%) 
Angina pectoris  1  4/112 (3.57%) 
Aortic valve disease  1  1/112 (0.89%) 
Aortic valve incompetence  1  1/112 (0.89%) 
Arrhythmia  1  1/112 (0.89%) 
Arteriosclerosis coronary artery  1  4/112 (3.57%) 
Atrial fibrillation  1  11/112 (9.82%) 
Bradycardia  1  4/112 (3.57%) 
Cardiac failure chronic  1  1/112 (0.89%) 
Cardiac failure congestive  1  3/112 (2.68%) 
Cardiomegaly  1  8/112 (7.14%) 
Cardiomyopathy  1  3/112 (2.68%) 
Coronary artery disease  1  1/112 (0.89%) 
Diastolic dysfunction  1  2/112 (1.79%) 
Dilatation atrial  1  1/112 (0.89%) 
Dilatation ventricular  1  2/112 (1.79%) 
Electromechanical dissociation  1  1/112 (0.89%) 
Extrasystoles  1  2/112 (1.79%) 
Heart valve incompetence  1  1/112 (0.89%) 
Left atrial dilatation  1  5/112 (4.46%) 
Left ventricular hypertrophy  1  4/112 (3.57%) 
Mitral valve calcification  1  1/112 (0.89%) 
Mitral valve incompetence  1  3/112 (2.68%) 
Palpitations  1  6/112 (5.36%) 
Pericardial cyst  1  1/112 (0.89%) 
Pericardial effusion  1  11/112 (9.82%) 
Pulmonary valve incompetence  1  2/112 (1.79%) 
Right atrial dilatation  1  1/112 (0.89%) 
Right ventricular dysfunction  1  1/112 (0.89%) 
Sinus bradycardia  1  3/112 (2.68%) 
Sinus tachycardia  1  7/112 (6.25%) 
Supraventricular extrasystoles  1  2/112 (1.79%) 
Supraventricular tachycardia  1  1/112 (0.89%) 
Tachycardia  1  25/112 (22.32%) 
Tricuspid valve incompetence  1  3/112 (2.68%) 
Ventricular extrasystoles  1  3/112 (2.68%) 
Ventricular hypokinesia  1  1/112 (0.89%) 
Ear and labyrinth disorders   
Cerumen impaction  1  1/112 (0.89%) 
Ear congestion  1  2/112 (1.79%) 
Ear discomfort  1  2/112 (1.79%) 
Ear pain  1  2/112 (1.79%) 
Hypoacusis  1  2/112 (1.79%) 
Tinnitus  1  1/112 (0.89%) 
Tympanic membrane disorder  1  1/112 (0.89%) 
Vertigo  1  5/112 (4.46%) 
Endocrine disorders   
Adrenal insufficiency  1  1/112 (0.89%) 
Inappropriate antidiuretic hormone secre  1  1/112 (0.89%) 
Eye disorders   
Conjunctival haemorrhage  1  3/112 (2.68%) 
Conjunctival hyperaemia  1  1/112 (0.89%) 
Conjunctival oedema  1  1/112 (0.89%) 
Conjunctivitis  1  3/112 (2.68%) 
Diplopia  1  2/112 (1.79%) 
Dry eye  1  8/112 (7.14%) 
Eye disorder  1  1/112 (0.89%) 
Eye oedema  1  1/112 (0.89%) 
Eye swelling  1  1/112 (0.89%) 
Eyelid disorder  1  1/112 (0.89%) 
Eyelid oedema  1  1/112 (0.89%) 
Eyelid ptosis  1  1/112 (0.89%) 
Lacrimation increased  1  2/112 (1.79%) 
Mydriasis  1  1/112 (0.89%) 
Ocular hyperaemia  1  1/112 (0.89%) 
Photophobia  1  2/112 (1.79%) 
Pinguecula  1  1/112 (0.89%) 
Scleral oedema  1  1/112 (0.89%) 
Vision blurred  1  6/112 (5.36%) 
Visual acuity reduced  1  1/112 (0.89%) 
Visual impairment  1  4/112 (3.57%) 
Vitreous haemorrhage  1  1/112 (0.89%) 
Gastrointestinal disorders   
Abdominal discomfort  1  6/112 (5.36%) 
Abdominal distension  1  14/112 (12.50%) 
Abdominal pain  1  27/112 (24.11%) 
Abdominal pain lower  1  4/112 (3.57%) 
Abdominal pain upper  1  6/112 (5.36%) 
Abdominal tenderness  1  8/112 (7.14%) 
Anal fissure  1  1/112 (0.89%) 
Anal pruritus  1  1/112 (0.89%) 
Anorectal discomfort  1  1/112 (0.89%) 
Aphthous stomatitis  1  1/112 (0.89%) 
Ascites  1  1/112 (0.89%) 
Bowel movement irregularity  1  1/112 (0.89%) 
Caecitis  1  1/112 (0.89%) 
Chapped lips  1  1/112 (0.89%) 
Cheilitis  1  1/112 (0.89%) 
Constipation  1  48/112 (42.86%) 
Dental caries  1  1/112 (0.89%) 
Diarrhoea  1  72/112 (64.29%) 
Diverticulum  1  2/112 (1.79%) 
Dry mouth  1  13/112 (11.61%) 
Dyspepsia  1  16/112 (14.29%) 
Dysphagia  1  10/112 (8.93%) 
Epigastric discomfort  1  1/112 (0.89%) 
Faecal incontinence  1  5/112 (4.46%) 
Faecaloma  1  1/112 (0.89%) 
Faeces hard  1  1/112 (0.89%) 
Flatulence  1  8/112 (7.14%) 
Gastrointestinal haemorrhage  1  2/112 (1.79%) 
Gastrointestinal sounds abnormal  1  1/112 (0.89%) 
Gastrooesophageal reflux disease  1  5/112 (4.46%) 
Gingival bleeding  1  2/112 (1.79%) 
Gingival pain  1  1/112 (0.89%) 
Gingivitis  1  4/112 (3.57%) 
Glossodynia  1  1/112 (0.89%) 
Haematemesis  1  2/112 (1.79%) 
Haematochezia  1  4/112 (3.57%) 
Haemorrhoidal haemorrhage  1  4/112 (3.57%) 
Haemorrhoids  1  15/112 (13.39%) 
Hiatus hernia  1  5/112 (4.46%) 
Hypoaesthesia oral  1  1/112 (0.89%) 
Ileus  1  4/112 (3.57%) 
Lip blister  1  1/112 (0.89%) 
Lip dry  1  6/112 (5.36%) 
Lip swelling  1  1/112 (0.89%) 
Lip ulceration  1  2/112 (1.79%) 
Loose tooth  1  1/112 (0.89%) 
Melaena  1  3/112 (2.68%) 
Mouth haemorrhage  1  10/112 (8.93%) 
Mouth ulceration  1  6/112 (5.36%) 
Nausea  1  85/112 (75.89%) 
Odynophagia  1  3/112 (2.68%) 
Oesophagitis  1  1/112 (0.89%) 
Oral discomfort  1  1/112 (0.89%) 
Oral disorder  1  4/112 (3.57%) 
Oral pain  1  5/112 (4.46%) 
Pancreatic atrophy  1  1/112 (0.89%) 
Pancreatitis  1  5/112 (4.46%) 
Proctalgia  1  1/112 (0.89%) 
Proctitis ulcerative  1  1/112 (0.89%) 
Rectal haemorrhage  1  3/112 (2.68%) 
Rectal prolapse  1  1/112 (0.89%) 
Retching  1  2/112 (1.79%) 
Saliva altered  1  1/112 (0.89%) 
Stomatitis  1  12/112 (10.71%) 
Tongue discolouration  1  1/112 (0.89%) 
Tongue disorder  1  1/112 (0.89%) 
Tongue haemorrhage  1  1/112 (0.89%) 
Toothache  1  2/112 (1.79%) 
Upper gastrointestinal haemorrhage  1  1/112 (0.89%) 
Vomiting  1  63/112 (56.25%) 
General disorders   
Asthenia  1  22/112 (19.64%) 
Catheter site discharge  1  4/112 (3.57%) 
Catheter site erythema  1  21/112 (18.75%) 
Catheter site haematoma  1  4/112 (3.57%) 
Catheter site haemorrhage  1  5/112 (4.46%) 
Catheter site inflammation  1  2/112 (1.79%) 
Catheter site oedema  1  1/112 (0.89%) 
Catheter site pain  1  13/112 (11.61%) 
Catheter site rash  1  2/112 (1.79%) 
Catheter site related reaction  1  2/112 (1.79%) 
Chest discomfort  1  5/112 (4.46%) 
Chest pain  1  5/112 (4.46%) 
Chills  1  40/112 (35.71%) 
Device occlusion  1  2/112 (1.79%) 
Discomfort  1  1/112 (0.89%) 
Face oedema  1  1/112 (0.89%) 
Facial pain  1  2/112 (1.79%) 
Fatigue  1  40/112 (35.71%) 
Gait disturbance  1  1/112 (0.89%) 
General physical health deterioration  1  1/112 (0.89%) 
Generalised oedema  1  5/112 (4.46%) 
Granuloma  1  1/112 (0.89%) 
Hypothermia  1  1/112 (0.89%) 
Infusion site induration  1  1/112 (0.89%) 
Infusion site urticaria  1  1/112 (0.89%) 
Injection site haematoma  1  1/112 (0.89%) 
Irritability  1  2/112 (1.79%) 
Local swelling  1  1/112 (0.89%) 
Localised oedema  1  3/112 (2.68%) 
Malaise  1  9/112 (8.04%) 
Mucosal dryness  1  3/112 (2.68%) 
Mucosal inflammation  1  18/112 (16.07%) 
Non-cardiac chest pain  1  4/112 (3.57%) 
Oedema  1  8/112 (7.14%) 
Oedema peripheral  1  63/112 (56.25%) 
Pain  1  12/112 (10.71%) 
Pyrexia  1  44/112 (39.29%) 
Swelling  1  1/112 (0.89%) 
Temperature intolerance  1  1/112 (0.89%) 
Thrombosis in device  1  3/112 (2.68%) 
Hepatobiliary disorders   
Cholelithiasis  1  4/112 (3.57%) 
Gallbladder disorder  1  2/112 (1.79%) 
Gallbladder oedema  1  2/112 (1.79%) 
Granulomatous liver disease  1  1/112 (0.89%) 
Hepatic cirrhosis  1  1/112 (0.89%) 
Hepatic cyst  1  3/112 (2.68%) 
Hepatic lesion  1  1/112 (0.89%) 
Hyperbilirubinaemia  1  10/112 (8.93%) 
Jaundice  1  2/112 (1.79%) 
Portal hypertension  1  1/112 (0.89%) 
Immune system disorders   
Drug hypersensitivity  1  6/112 (5.36%) 
Hypersensitivity  1  1/112 (0.89%) 
Seasonal allergy  1  2/112 (1.79%) 
Infections and infestations   
Alpha haemolytic streptococcal infection  1  1/112 (0.89%) 
Atypical mycobacterial infection  1  1/112 (0.89%) 
Bacteraemia  1  4/112 (3.57%) 
Bacterial infection  1  3/112 (2.68%) 
Bacteroides infection  1  1/112 (0.89%) 
Bronchopulmonary aspergillosis  1  1/112 (0.89%) 
Candidiasis  1  4/112 (3.57%) 
Cellulitis  1  6/112 (5.36%) 
Chronic sinusitis  1  1/112 (0.89%) 
Clostridial infection  1  4/112 (3.57%) 
Clostridium difficile colitis  1  7/112 (6.25%) 
Cystitis  1  1/112 (0.89%) 
Device related infection  1  4/112 (3.57%) 
Device related sepsis  1  1/112 (0.89%) 
Enterobacter infection  1  1/112 (0.89%) 
Enterococcal bacteraemia  1  3/112 (2.68%) 
Enterococcal infection  1  5/112 (4.46%) 
Escherichia bacteraemia  1  1/112 (0.89%) 
Escherichia sepsis  1  1/112 (0.89%) 
Folliculitis  1  1/112 (0.89%) 
Fungal infection  1  2/112 (1.79%) 
Gastroenteritis viral  1  1/112 (0.89%) 
Gastrointestinal candidiasis  1  1/112 (0.89%) 
Genital herpes  1  3/112 (2.68%) 
Hepatitis b  1  1/112 (0.89%) 
Herpes simplex  1  1/112 (0.89%) 
Herpes zoster  1  1/112 (0.89%) 
Jc virus infection  1  1/112 (0.89%) 
Lobar pneumonia  1  1/112 (0.89%) 
Lung infection pseudomonal  1  1/112 (0.89%) 
Mastoiditis  1  1/112 (0.89%) 
Morganella infection  1  1/112 (0.89%) 
Nasopharyngitis  1  1/112 (0.89%) 
Neutropenic infection  1  1/112 (0.89%) 
Neutropenic sepsis  1  2/112 (1.79%) 
Oral candidiasis  1  18/112 (16.07%) 
Oral herpes  1  5/112 (4.46%) 
Oral viral infection  1  1/112 (0.89%) 
Otitis media  1  1/112 (0.89%) 
Perineal abscess  1  1/112 (0.89%) 
Pneumonia  1  17/112 (15.18%) 
Pneumonia bacterial  1  1/112 (0.89%) 
Pneumonia fungal  1  3/112 (2.68%) 
Post procedural cellulitis  1  1/112 (0.89%) 
Pseudomonal sepsis  1  1/112 (0.89%) 
Pseudomonas infection  1  1/112 (0.89%) 
Pulmonary mycosis  1  2/112 (1.79%) 
Pyelonephritis  1  1/112 (0.89%) 
Rash pustular  1  1/112 (0.89%) 
Respiratory moniliasis  1  1/112 (0.89%) 
Septic shock  1  1/112 (0.89%) 
Sinusitis  1  2/112 (1.79%) 
Sinusitis fungal  1  1/112 (0.89%) 
Staphylococcal bacteraemia  1  8/112 (7.14%) 
Staphylococcal infection  1  4/112 (3.57%) 
Streptococcal bacteraemia  1  1/112 (0.89%) 
Tinea pedis  1  1/112 (0.89%) 
Upper respiratory tract infection  1  3/112 (2.68%) 
Urinary tract infection  1  5/112 (4.46%) 
Urinary tract infection bacterial  1  1/112 (0.89%) 
Urinary tract infection enterococcal  1  1/112 (0.89%) 
Urinary tract infection pseudomonal  1  1/112 (0.89%) 
Vulval abscess  1  1/112 (0.89%) 
Injury, poisoning and procedural complications   
Allergic transfusion reaction  1  1/112 (0.89%) 
Contusion  1  17/112 (15.18%) 
Excoriation  1  3/112 (2.68%) 
Fall  1  3/112 (2.68%) 
Muscle strain  1  1/112 (0.89%) 
Periorbital haematoma  1  3/112 (2.68%) 
Pocket erosion  1  1/112 (0.89%) 
Post procedural haemorrhage  1  2/112 (1.79%) 
Post-traumatic pain  1  2/112 (1.79%) 
Postoperative wound complication  1  1/112 (0.89%) 
Procedural pain  1  7/112 (6.25%) 
Renal haematoma  1  1/112 (0.89%) 
Skeletal injury  1  1/112 (0.89%) 
Skin laceration  1  5/112 (4.46%) 
Spinal compression fracture  1  1/112 (0.89%) 
Subdural haematoma  1  1/112 (0.89%) 
Subdural haemorrhage  1  1/112 (0.89%) 
Transfusion reaction  1  4/112 (3.57%) 
Wound dehiscence  1  1/112 (0.89%) 
Investigations   
Alanine aminotransferase increased  1  26/112 (23.21%) 
Antibiotic resistant staphylococcus test  1  1/112 (0.89%) 
Aspartate aminotransferase increased  1  24/112 (21.43%) 
Bacterial test positive  1  1/112 (0.89%) 
Blood albumin decreased  1  1/112 (0.89%) 
Blood alkaline phosphatase increased  1  5/112 (4.46%) 
Blood amylase increased  1  5/112 (4.46%) 
Blood bicarbonate decreased  1  1/112 (0.89%) 
Blood bicarbonate increased  1  1/112 (0.89%) 
Blood bilirubin increased  1  7/112 (6.25%) 
Blood chloride decreased  1  1/112 (0.89%) 
Blood creatinine increased  1  13/112 (11.61%) 
Blood culture positive  1  2/112 (1.79%) 
Blood glucose increased  1  1/112 (0.89%) 
Blood lactate dehydrogenase increased  1  3/112 (2.68%) 
Blood phosphorus decreased  1  2/112 (1.79%) 
Blood phosphorus increased  1  2/112 (1.79%) 
Blood potassium decreased  1  1/112 (0.89%) 
Blood pressure increased  1  1/112 (0.89%) 
Blood sodium decreased  1  1/112 (0.89%) 
Blood urea increased  1  1/112 (0.89%) 
Blood urine present  1  1/112 (0.89%) 
Bone density increased  1  1/112 (0.89%) 
Brain natriuretic peptide increased  1  3/112 (2.68%) 
Breath sounds abnormal  1  10/112 (8.93%) 
Cardiac murmur  1  10/112 (8.93%) 
Chest x-ray abnormal  1  3/112 (2.68%) 
Clostridium test positive  1  1/112 (0.89%) 
Coagulation time prolonged  1  1/112 (0.89%) 
Culture urine positive  1  2/112 (1.79%) 
Electrocardiogram qt prolonged  1  3/112 (2.68%) 
Electrocardiogram st segment abnormal  1  1/112 (0.89%) 
Electrocardiogram st segment depression  1  1/112 (0.89%) 
Electrocardiogram t wave abnormal  1  4/112 (3.57%) 
Enterococcus test positive  1  3/112 (2.68%) 
Eosinophil count increased  1  1/112 (0.89%) 
Face and mouth x-ray abnormal  1  1/112 (0.89%) 
Fungal test positive  1  1/112 (0.89%) 
Haemoglobin  1  1/112 (0.89%) 
Haemoglobin decreased  1  1/112 (0.89%) 
Heart rate irregular  1  4/112 (3.57%) 
Heart sounds abnormal  1  1/112 (0.89%) 
International normalised ratio increased  1  1/112 (0.89%) 
Lipase increased  1  7/112 (6.25%) 
Liver function test abnormal  1  3/112 (2.68%) 
Liver palpable subcostal  1  1/112 (0.89%) 
Occult blood positive  1  3/112 (2.68%) 
Oxygen saturation decreased  1  1/112 (0.89%) 
Protein total decreased  1  1/112 (0.89%) 
Pulmonary arterial pressure increased  1  1/112 (0.89%) 
Right ventricular systolic pressure incr  1  1/112 (0.89%) 
Streptococcus test positive  1  2/112 (1.79%) 
Transaminases increased  1  8/112 (7.14%) 
Troponin I  1  1/112 (0.89%) 
Troponin I increased  1  1/112 (0.89%) 
Urine analysis abnormal  1  1/112 (0.89%) 
Urine output decreased  1  2/112 (1.79%) 
Weight decreased  1  17/112 (15.18%) 
Weight increased  1  3/112 (2.68%) 
White blood cell count decreased  1  1/112 (0.89%) 
Metabolism and nutrition disorders   
Acidosis  1  1/112 (0.89%) 
Cachexia  1  2/112 (1.79%) 
Decreased appetite  1  45/112 (40.18%) 
Dehydration  1  8/112 (7.14%) 
Diabetes mellitus  1  1/112 (0.89%) 
Fluid imbalance  1  1/112 (0.89%) 
Fluid overload  1  18/112 (16.07%) 
Fluid retention  1  2/112 (1.79%) 
Gout  1  2/112 (1.79%) 
Hypercalcaemia  1  1/112 (0.89%) 
Hyperglycaemia  1  10/112 (8.93%) 
Hyperkalaemia  1  2/112 (1.79%) 
Hypermagnesaemia  1  1/112 (0.89%) 
Hypernatraemia  1  1/112 (0.89%) 
Hyperphosphataemia  1  7/112 (6.25%) 
Hyperuricaemia  1  2/112 (1.79%) 
Hypervolaemia  1  1/112 (0.89%) 
Hypoalbuminaemia  1  6/112 (5.36%) 
Hypocalcaemia  1  7/112 (6.25%) 
Hypochloraemia  1  1/112 (0.89%) 
Hypoglycaemia  1  1/112 (0.89%) 
Hypokalaemia  1  36/112 (32.14%) 
Hypomagnesaemia  1  14/112 (12.50%) 
Hyponatraemia  1  9/112 (8.04%) 
Hypophagia  1  1/112 (0.89%) 
Hypophosphataemia  1  13/112 (11.61%) 
Increased appetite  1  1/112 (0.89%) 
Metabolic acidosis  1  1/112 (0.89%) 
Metabolic alkalosis  1  1/112 (0.89%) 
Podagra  1  1/112 (0.89%) 
Polydipsia  1  1/112 (0.89%) 
Tumour lysis syndrome  1  6/112 (5.36%) 
Vitamin k deficiency  1  1/112 (0.89%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  22/112 (19.64%) 
Back pain  1  25/112 (22.32%) 
Bone lesion  1  1/112 (0.89%) 
Bone pain  1  13/112 (11.61%) 
Bursitis  1  1/112 (0.89%) 
Flank pain  1  3/112 (2.68%) 
Groin pain  1  1/112 (0.89%) 
Intervertebral disc degeneration  1  1/112 (0.89%) 
Intervertebral disc protrusion  1  1/112 (0.89%) 
Joint range of motion decreased  1  1/112 (0.89%) 
Joint swelling  1  2/112 (1.79%) 
Kyphosis  1  1/112 (0.89%) 
Limb discomfort  1  1/112 (0.89%) 
Mobility decreased  1  1/112 (0.89%) 
Muscle spasms  1  7/112 (6.25%) 
Muscle tightness  1  1/112 (0.89%) 
Muscle twitching  1  1/112 (0.89%) 
Muscular weakness  1  4/112 (3.57%) 
Musculoskeletal chest pain  1  5/112 (4.46%) 
Musculoskeletal discomfort  1  6/112 (5.36%) 
Musculoskeletal pain  1  18/112 (16.07%) 
Musculoskeletal stiffness  1  4/112 (3.57%) 
Myalgia  1  11/112 (9.82%) 
Myopathy  1  1/112 (0.89%) 
Neck pain  1  11/112 (9.82%) 
Nodule on extremity  1  2/112 (1.79%) 
Osteoarthritis  1  1/112 (0.89%) 
Osteosclerosis  1  1/112 (0.89%) 
Pain in extremity  1  28/112 (25.00%) 
Pain in jaw  1  3/112 (2.68%) 
Posture abnormal  1  1/112 (0.89%) 
Rhabdomyolysis  1  1/112 (0.89%) 
Spinal osteoarthritis  1  2/112 (1.79%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic neoplasm  1  2/112 (1.79%) 
Leukaemia cutis  1  1/112 (0.89%) 
Leukaemic retinopathy  1  2/112 (1.79%) 
Lung neoplasm  1  6/112 (5.36%) 
Spinal haemangioma  1  1/112 (0.89%) 
Uterine leiomyoma  1  1/112 (0.89%) 
Nervous system disorders   
Amnesia  1  3/112 (2.68%) 
Aphasia  1  1/112 (0.89%) 
Ataxia  1  2/112 (1.79%) 
Balance disorder  1  2/112 (1.79%) 
Burning sensation  1  1/112 (0.89%) 
Cerebral haemorrhage  1  1/112 (0.89%) 
Cerebrovascular accident  1  1/112 (0.89%) 
Cerebrovascular disorder  1  1/112 (0.89%) 
Cognitive disorder  1  1/112 (0.89%) 
Dementia  1  1/112 (0.89%) 
Disturbance in attention  1  2/112 (1.79%) 
Dizziness  1  26/112 (23.21%) 
Dizziness postural  1  1/112 (0.89%) 
Dysarthria  1  5/112 (4.46%) 
Dysgeusia  1  8/112 (7.14%) 
Embolic stroke  1  1/112 (0.89%) 
Encephalopathy  1  1/112 (0.89%) 
Facial palsy  1  1/112 (0.89%) 
Facial paresis  1  1/112 (0.89%) 
Headache  1  45/112 (40.18%) 
Hyperaesthesia  1  1/112 (0.89%) 
Hypoaesthesia  1  4/112 (3.57%) 
Lethargy  1  3/112 (2.68%) 
Memory impairment  1  1/112 (0.89%) 
Migraine  1  1/112 (0.89%) 
Myoclonus  1  1/112 (0.89%) 
Neuralgia  1  1/112 (0.89%) 
Neuropathy peripheral  1  6/112 (5.36%) 
Orthostatic intolerance  1  1/112 (0.89%) 
Paraesthesia  1  11/112 (9.82%) 
Parosmia  1  2/112 (1.79%) 
Peroneal nerve palsy  1  1/112 (0.89%) 
Poor quality sleep  1  1/112 (0.89%) 
Presyncope  1  2/112 (1.79%) 
Radial nerve palsy  1  1/112 (0.89%) 
Restless legs syndrome  1  3/112 (2.68%) 
Sciatica  1  1/112 (0.89%) 
Sensory loss  1  1/112 (0.89%) 
Sinus headache  1  4/112 (3.57%) 
Somnolence  1  10/112 (8.93%) 
Subarachnoid haemorrhage  1  1/112 (0.89%) 
Syncope  1  6/112 (5.36%) 
Tension headache  1  1/112 (0.89%) 
Tongue paralysis  1  1/112 (0.89%) 
Transient ischaemic attack  1  1/112 (0.89%) 
Tremor  1  5/112 (4.46%) 
Psychiatric disorders   
Abnormal behaviour  1  1/112 (0.89%) 
Abnormal dreams  1  1/112 (0.89%) 
Aggression  1  1/112 (0.89%) 
Agitation  1  8/112 (7.14%) 
Anxiety  1  26/112 (23.21%) 
Claustrophobia  1  1/112 (0.89%) 
Confusional state  1  25/112 (22.32%) 
Depressed mood  1  1/112 (0.89%) 
Depression  1  14/112 (12.50%) 
Disorientation  1  3/112 (2.68%) 
Hallucination  1  4/112 (3.57%) 
Hallucination, visual  1  2/112 (1.79%) 
Insomnia  1  46/112 (41.07%) 
Mental status changes  1  8/112 (7.14%) 
Mood altered  1  1/112 (0.89%) 
Nervousness  1  2/112 (1.79%) 
Panic attack  1  1/112 (0.89%) 
Phonophobia  1  1/112 (0.89%) 
Restlessness  1  1/112 (0.89%) 
Renal and urinary disorders   
Acute prerenal failure  1  1/112 (0.89%) 
Bladder dilatation  1  3/112 (2.68%) 
Bladder hypertrophy  1  1/112 (0.89%) 
Bladder pain  1  1/112 (0.89%) 
Bladder spasm  1  3/112 (2.68%) 
Chromaturia  1  1/112 (0.89%) 
Dysuria  1  6/112 (5.36%) 
Haematuria  1  9/112 (8.04%) 
Hydronephrosis  1  1/112 (0.89%) 
Ketonuria  1  1/112 (0.89%) 
Micturition urgency  1  1/112 (0.89%) 
Nephrolithiasis  1  4/112 (3.57%) 
Oliguria  1  1/112 (0.89%) 
Pollakiuria  1  4/112 (3.57%) 
Polyuria  1  1/112 (0.89%) 
Proteinuria  1  1/112 (0.89%) 
Renal cyst  1  4/112 (3.57%) 
Renal failure  1  8/112 (7.14%) 
Renal failure acute  1  1/112 (0.89%) 
Ureteric stenosis  1  1/112 (0.89%) 
Urinary hesitation  1  1/112 (0.89%) 
Urinary incontinence  1  11/112 (9.82%) 
Urinary retention  1  5/112 (4.46%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/112 (0.89%) 
Breast hyperplasia  1  1/112 (0.89%) 
Fibrocystic breast disease  1  1/112 (0.89%) 
Genital rash  1  1/112 (0.89%) 
Oedema genital  1  1/112 (0.89%) 
Pelvic fluid collection  1  1/112 (0.89%) 
Pelvic pain  1  1/112 (0.89%) 
Penile swelling  1  2/112 (1.79%) 
Prostatomegaly  1  1/112 (0.89%) 
Scrotal haematocoele  1  1/112 (0.89%) 
Vaginal haemorrhage  1  3/112 (2.68%) 
Vulvovaginal discomfort  1  1/112 (0.89%) 
Vulvovaginal pruritus  1  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/112 (0.89%) 
Allergic sinusitis  1  1/112 (0.89%) 
Atelectasis  1  14/112 (12.50%) 
Cough  1  34/112 (30.36%) 
Dysphonia  1  1/112 (0.89%) 
Dyspnoea  1  33/112 (29.46%) 
Dyspnoea exertional  1  3/112 (2.68%) 
Dyspnoea paroxysmal nocturnal  1  1/112 (0.89%) 
Egobronchophony  1  1/112 (0.89%) 
Emphysema  1  1/112 (0.89%) 
Epistaxis  1  30/112 (26.79%) 
Haemoptysis  1  17/112 (15.18%) 
Hiccups  1  4/112 (3.57%) 
Hypoxia  1  17/112 (15.18%) 
Increased upper airway secretion  1  1/112 (0.89%) 
Lung consolidation  1  3/112 (2.68%) 
Lung disorder  1  1/112 (0.89%) 
Lung infiltration  1  5/112 (4.46%) 
Nasal congestion  1  7/112 (6.25%) 
Nasal discomfort  1  1/112 (0.89%) 
Nasal dryness  1  1/112 (0.89%) 
Obstructive airways disorder  1  1/112 (0.89%) 
Oropharyngeal blistering  1  3/112 (2.68%) 
Oropharyngeal pain  1  15/112 (13.39%) 
Orthopnoea  1  1/112 (0.89%) 
Painful respiration  1  5/112 (4.46%) 
Paranasal sinus hypersecretion  1  4/112 (3.57%) 
Pharyngeal erythema  1  4/112 (3.57%) 
Pleural effusion  1  26/112 (23.21%) 
Pleuritic pain  1  5/112 (4.46%) 
Pneumonitis  1  3/112 (2.68%) 
Postnasal drip  1  4/112 (3.57%) 
Productive cough  1  4/112 (3.57%) 
Prolonged expiration  1  1/112 (0.89%) 
Pulmonary alveolar haemorrhage  1  1/112 (0.89%) 
Pulmonary congestion  1  1/112 (0.89%) 
Pulmonary granuloma  1  1/112 (0.89%) 
Pulmonary haemorrhage  1  2/112 (1.79%) 
Pulmonary hypertension  1  2/112 (1.79%) 
Pulmonary oedema  1  14/112 (12.50%) 
Rales  1  19/112 (16.96%) 
Respiratory acidosis  1  1/112 (0.89%) 
Respiratory alkalosis  1  1/112 (0.89%) 
Respiratory distress  1  2/112 (1.79%) 
Rhinitis allergic  1  1/112 (0.89%) 
Rhinorrhoea  1  6/112 (5.36%) 
Rhonchi  1  3/112 (2.68%) 
Sinus congestion  1  8/112 (7.14%) 
Sinus disorder  1  2/112 (1.79%) 
Sputum discoloured  1  1/112 (0.89%) 
Tachypnoea  1  9/112 (8.04%) 
Upper airway obstruction  1  1/112 (0.89%) 
Wheezing  1  10/112 (8.93%) 
Skin and subcutaneous tissue disorders   
Acute febrile neutrophilic dermatosis  1  1/112 (0.89%) 
Alopecia  1  3/112 (2.68%) 
Blister  1  3/112 (2.68%) 
Blood blister  1  3/112 (2.68%) 
Decubitus ulcer  1  7/112 (6.25%) 
Dermatitis acneiform  1  2/112 (1.79%) 
Dermatitis allergic  1  1/112 (0.89%) 
Drug eruption  1  3/112 (2.68%) 
Dry skin  1  9/112 (8.04%) 
Ecchymosis  1  19/112 (16.96%) 
Erythema  1  14/112 (12.50%) 
Exfoliative rash  1  3/112 (2.68%) 
Hyperhidrosis  1  14/112 (12.50%) 
Increased tendency to bruise  1  2/112 (1.79%) 
Leukoplakia  1  1/112 (0.89%) 
Nail disorder  1  1/112 (0.89%) 
Night sweats  1  7/112 (6.25%) 
Palmar erythema  1  1/112 (0.89%) 
Palmar-plantar erythrodysaesthesia syndr  1  1/112 (0.89%) 
Periorbital oedema  1  3/112 (2.68%) 
Petechiae  1  29/112 (25.89%) 
Pruritus  1  26/112 (23.21%) 
Pruritus generalised  1  1/112 (0.89%) 
Purpura  1  2/112 (1.79%) 
Rash  1  52/112 (46.43%) 
Rash erythematous  1  3/112 (2.68%) 
Rash generalised  1  15/112 (13.39%) 
Rash macular  1  6/112 (5.36%) 
Rash maculo-papular  1  5/112 (4.46%) 
Rash papular  1  4/112 (3.57%) 
Rash pruritic  1  6/112 (5.36%) 
Skin disorder  1  1/112 (0.89%) 
Skin exfoliation  1  1/112 (0.89%) 
Skin haemorrhage  1  1/112 (0.89%) 
Skin irritation  1  2/112 (1.79%) 
Skin lesion  1  6/112 (5.36%) 
Skin mass  1  1/112 (0.89%) 
Skin necrosis  1  2/112 (1.79%) 
Skin oedema  1  1/112 (0.89%) 
Skin ulcer  1  2/112 (1.79%) 
Swelling face  1  1/112 (0.89%) 
Urticaria  1  5/112 (4.46%) 
Surgical and medical procedures   
Fasciotomy  1  1/112 (0.89%) 
Leg amputation  1  1/112 (0.89%) 
Vascular disorders   
Aortic aneurysm  1  3/112 (2.68%) 
Aortic calcification  1  1/112 (0.89%) 
Aortic stenosis  1  1/112 (0.89%) 
Arteriosclerosis  1  2/112 (1.79%) 
Capillary leak syndrome  1  1/112 (0.89%) 
Deep vein thrombosis  1  3/112 (2.68%) 
Flushing  1  13/112 (11.61%) 
Haematoma  1  8/112 (7.14%) 
Haemorrhage  1  1/112 (0.89%) 
Hot flush  1  1/112 (0.89%) 
Hypertension  1  22/112 (19.64%) 
Hypertensive crisis  1  1/112 (0.89%) 
Hypotension  1  32/112 (28.57%) 
Orthostatic hypertension  1  1/112 (0.89%) 
Orthostatic hypotension  1  6/112 (5.36%) 
Pallor  1  4/112 (3.57%) 
Peripheral coldness  1  1/112 (0.89%) 
Phlebitis  1  1/112 (0.89%) 
Thrombophlebitis superficial  1  1/112 (0.89%) 
Thrombosis  1  1/112 (0.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00373529     History of Changes
Other Study ID Numbers: CLO24300606
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: February 24, 2011
Results First Posted: March 24, 2011
Last Update Posted: April 14, 2014