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Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).

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ClinicalTrials.gov Identifier: NCT01090323
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : January 20, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: ICL670
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ICL670 Crossover
Hide Arm/Group Description Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight. Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Period Title: Overall Study
Started 132 53
Completed 43 19
Not Completed 89 34
Reason Not Completed
Adverse Event             12             2
Abnormal Lab Values             3             1
Abnormal Test Procedure Results             2             0
Unsatisfactory therapeutic effect             4             2
Condition no longer requires drug             5             4
Protocol Violation             2             1
Withdrew consent             33             11
Lost to Follow-up             11             6
Administrative problems             6             4
Death             1             2
Stopped end of core             7             0
Stopped end of extension 1#             3             1
Arm/Group Title ICL670 Crossover Total
Hide Arm/Group Description Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight. Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight. Total of all reporting groups
Overall Number of Baseline Participants 132 53 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 132 participants 53 participants 185 participants
<12 years 33 14 47
12 - <16 years 32 11 43
16 - <65 years 67 28 95
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 53 participants 185 participants
Female
80
  60.6%
31
  58.5%
111
  60.0%
Male
52
  39.4%
22
  41.5%
74
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 132 participants 53 participants 185 participants
France 10 2 12
United States 110 46 156
Canada 0 1 1
United Kingdom 5 1 6
Italy 7 3 10
1.Primary Outcome
Title Number of Participants With Adverse Events After Start of ICL670
Hide Description Safety as assessed by the number of participants with adverse event or death after the start of ICL670.
Time Frame 0 - 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.
Arm/Group Title ICL670 Crossover
Hide Arm/Group Description:
Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Overall Number of Participants Analyzed 132 53
Measure Type: Number
Unit of Measure: participants
Adverse Events 131 49
Deaths 1 2
2.Secondary Outcome
Title Change in Serum Ferritin From Start of ICL670 to End of Study
Hide Description The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.
Time Frame 0 - 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.
Arm/Group Title ICL670 Crossover
Hide Arm/Group Description:
Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Overall Number of Participants Analyzed 132 53
Median (Full Range)
Unit of Measure: µg/L
-245.5
(-8701.3 to 7626.5)
-134.3
(-6124.0 to 5136.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ICL670 Crossover
Hide Arm/Group Description Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight. Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
All-Cause Mortality
ICL670 Crossover
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ICL670 Crossover
Affected / at Risk (%) Affected / at Risk (%)
Total   97/132 (73.48%)   34/53 (64.15%) 
Blood and lymphatic system disorders     
Acute chest syndrome  1  5/132 (3.79%)  3/53 (5.66%) 
Anaemia  1  1/132 (0.76%)  2/53 (3.77%) 
Anaemia haemolytic autoimmune  1  1/132 (0.76%)  0/53 (0.00%) 
Coagulopathy  1  1/132 (0.76%)  0/53 (0.00%) 
Haemolysis  1  2/132 (1.52%)  0/53 (0.00%) 
Haemolytic anaemia  1  1/132 (0.76%)  0/53 (0.00%) 
Hypersplenism  1  1/132 (0.76%)  0/53 (0.00%) 
Leukocytosis  1  1/132 (0.76%)  0/53 (0.00%) 
Lymphadenopathy  1  1/132 (0.76%)  0/53 (0.00%) 
Spleen disorder  1  1/132 (0.76%)  0/53 (0.00%) 
Splenomegaly  1  1/132 (0.76%)  0/53 (0.00%) 
Thrombocytopenia  1  1/132 (0.76%)  0/53 (0.00%) 
Cardiac disorders     
Arrhythmia  1  1/132 (0.76%)  0/53 (0.00%) 
Cardiac failure congestive  1  2/132 (1.52%)  0/53 (0.00%) 
Congenital, familial and genetic disorders     
Sickle cell anaemia  1  0/132 (0.00%)  1/53 (1.89%) 
Sickle cell anaemia with crisis  1  48/132 (36.36%)  19/53 (35.85%) 
Ear and labyrinth disorders     
Otorrhoea  1  1/132 (0.76%)  0/53 (0.00%) 
Tinnitus  1  0/132 (0.00%)  1/53 (1.89%) 
Eye disorders     
Vitreous haemorrhage  1  0/132 (0.00%)  1/53 (1.89%) 
Gastrointestinal disorders     
Abdominal pain  1  14/132 (10.61%)  4/53 (7.55%) 
Abdominal pain upper  1  3/132 (2.27%)  1/53 (1.89%) 
Ascites  1  1/132 (0.76%)  0/53 (0.00%) 
Constipation  1  2/132 (1.52%)  1/53 (1.89%) 
Dental caries  1  1/132 (0.76%)  0/53 (0.00%) 
Diarrhoea  1  2/132 (1.52%)  1/53 (1.89%) 
Food poisoning  1  0/132 (0.00%)  1/53 (1.89%) 
Gastrointestinal haemorrhage  1  2/132 (1.52%)  0/53 (0.00%) 
Gastrointestinal inflammation  1  1/132 (0.76%)  0/53 (0.00%) 
Nausea  1  3/132 (2.27%)  0/53 (0.00%) 
Pancreatitis  1  1/132 (0.76%)  0/53 (0.00%) 
Pancreatitis acute  1  1/132 (0.76%)  0/53 (0.00%) 
Retroperitoneal haemorrhage  1  1/132 (0.76%)  0/53 (0.00%) 
Tooth disorder  1  1/132 (0.76%)  0/53 (0.00%) 
Varices oesophageal  1  0/132 (0.00%)  1/53 (1.89%) 
Vomiting  1  7/132 (5.30%)  5/53 (9.43%) 
General disorders     
Asthenia  1  0/132 (0.00%)  1/53 (1.89%) 
Catheter related complication  1  0/132 (0.00%)  2/53 (3.77%) 
Catheter site haemorrhage  1  0/132 (0.00%)  1/53 (1.89%) 
Catheter site pain  1  1/132 (0.76%)  1/53 (1.89%) 
Catheter thrombosis  1  0/132 (0.00%)  1/53 (1.89%) 
Chest discomfort  1  1/132 (0.76%)  0/53 (0.00%) 
Chest pain  1  8/132 (6.06%)  4/53 (7.55%) 
Chills  1  1/132 (0.76%)  1/53 (1.89%) 
Facial pain  1  1/132 (0.76%)  0/53 (0.00%) 
Granuloma  1  1/132 (0.76%)  0/53 (0.00%) 
Local swelling  1  0/132 (0.00%)  1/53 (1.89%) 
Necrosis  1  1/132 (0.76%)  0/53 (0.00%) 
Non-cardiac chest pain  1  1/132 (0.76%)  0/53 (0.00%) 
Oedema peripheral  1  1/132 (0.76%)  0/53 (0.00%) 
Pain  1  6/132 (4.55%)  1/53 (1.89%) 
Pyrexia  1  25/132 (18.94%)  9/53 (16.98%) 
Hepatobiliary disorders     
Bile duct stone  1  1/132 (0.76%)  0/53 (0.00%) 
Biliary colic  1  1/132 (0.76%)  0/53 (0.00%) 
Cholecystitis  1  1/132 (0.76%)  1/53 (1.89%) 
Cholelithiasis  1  7/132 (5.30%)  2/53 (3.77%) 
Hepatic cirrhosis  1  1/132 (0.76%)  0/53 (0.00%) 
Hepatic failure  1  1/132 (0.76%)  0/53 (0.00%) 
Hepatic sequestration  1  1/132 (0.76%)  0/53 (0.00%) 
Hyperbilirubinaemia  1  0/132 (0.00%)  1/53 (1.89%) 
Jaundice  1  1/132 (0.76%)  0/53 (0.00%) 
Infections and infestations     
Abscess limb  1  0/132 (0.00%)  1/53 (1.89%) 
Adenovirus infection  1  1/132 (0.76%)  0/53 (0.00%) 
Appendicitis  1  0/132 (0.00%)  1/53 (1.89%) 
Bacteraemia  1  2/132 (1.52%)  0/53 (0.00%) 
Bronchitis  1  3/132 (2.27%)  2/53 (3.77%) 
Catheter bacteraemia  1  1/132 (0.76%)  0/53 (0.00%) 
Catheter related infection  1  5/132 (3.79%)  2/53 (3.77%) 
Cellulitis  1  3/132 (2.27%)  1/53 (1.89%) 
Central line infection  1  1/132 (0.76%)  1/53 (1.89%) 
Endocarditis  1  1/132 (0.76%)  0/53 (0.00%) 
Gastroenteritis  1  2/132 (1.52%)  3/53 (5.66%) 
Gastroenteritis viral  1  0/132 (0.00%)  1/53 (1.89%) 
Herpes zoster  1  0/132 (0.00%)  1/53 (1.89%) 
Influenza  1  1/132 (0.76%)  1/53 (1.89%) 
Lobar pneumonia  1  1/132 (0.76%)  0/53 (0.00%) 
Lung infection  1  1/132 (0.76%)  0/53 (0.00%) 
Mononucleosis syndrome  1  1/132 (0.76%)  0/53 (0.00%) 
Osteomyelitis  1  0/132 (0.00%)  1/53 (1.89%) 
Otitis media  1  1/132 (0.76%)  1/53 (1.89%) 
Pharyngitis streptococcal  1  0/132 (0.00%)  1/53 (1.89%) 
Pneumonia  1  13/132 (9.85%)  3/53 (5.66%) 
Pneumonia bacterial  1  1/132 (0.76%)  0/53 (0.00%) 
Pyelonephritis  1  1/132 (0.76%)  0/53 (0.00%) 
Pyelonephritis acute  1  1/132 (0.76%)  0/53 (0.00%) 
Respiratory syncytial virus infection  1  1/132 (0.76%)  0/53 (0.00%) 
Sepsis  1  3/132 (2.27%)  1/53 (1.89%) 
Sinusitis  1  1/132 (0.76%)  0/53 (0.00%) 
Staphylococcal bacteraemia  1  1/132 (0.76%)  0/53 (0.00%) 
Staphylococcal infection  1  1/132 (0.76%)  1/53 (1.89%) 
Staphylococcal sepsis  1  1/132 (0.76%)  0/53 (0.00%) 
Subcutaneous abscess  1  0/132 (0.00%)  1/53 (1.89%) 
Tuberculosis  1  1/132 (0.76%)  0/53 (0.00%) 
Upper respiratory tract infection  1  3/132 (2.27%)  3/53 (5.66%) 
Urinary tract infection  1  3/132 (2.27%)  1/53 (1.89%) 
Viral infection  1  1/132 (0.76%)  0/53 (0.00%) 
Viral upper respiratory tract infection  1  0/132 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/132 (0.00%)  1/53 (1.89%) 
Arteriovenous fistula thrombosis  1  0/132 (0.00%)  1/53 (1.89%) 
Citrate toxicity  1  1/132 (0.76%)  0/53 (0.00%) 
Collapse of lung  1  1/132 (0.76%)  0/53 (0.00%) 
Device failure  1  0/132 (0.00%)  1/53 (1.89%) 
Drug toxicity  1  1/132 (0.76%)  0/53 (0.00%) 
Excoriation  1  0/132 (0.00%)  1/53 (1.89%) 
Fall  1  0/132 (0.00%)  1/53 (1.89%) 
Haemolytic transfusion reaction  1  1/132 (0.76%)  0/53 (0.00%) 
Head injury  1  0/132 (0.00%)  1/53 (1.89%) 
Incision site pain  1  1/132 (0.76%)  0/53 (0.00%) 
Jaw fracture  1  1/132 (0.76%)  0/53 (0.00%) 
Medical device complication  1  0/132 (0.00%)  1/53 (1.89%) 
Meniscus lesion  1  1/132 (0.76%)  0/53 (0.00%) 
Overdose  1  0/132 (0.00%)  1/53 (1.89%) 
Patella fracture  1  0/132 (0.00%)  1/53 (1.89%) 
Transfusion reaction  1  3/132 (2.27%)  0/53 (0.00%) 
Vascular graft occlusion  1  0/132 (0.00%)  1/53 (1.89%) 
Investigations     
Alanine aminotransferase increased  1  1/132 (0.76%)  1/53 (1.89%) 
Aspartate aminotransferase increased  1  1/132 (0.76%)  1/53 (1.89%) 
Biopsy liver  1  1/132 (0.76%)  0/53 (0.00%) 
Blood alkaline phosphatase  1  1/132 (0.76%)  0/53 (0.00%) 
Blood amylase increased  1  1/132 (0.76%)  0/53 (0.00%) 
Blood bilirubin increased  1  1/132 (0.76%)  0/53 (0.00%) 
Blood iron increased  1  1/132 (0.76%)  0/53 (0.00%) 
Lipase increased  1  1/132 (0.76%)  0/53 (0.00%) 
Oxygen saturation decreased  1  1/132 (0.76%)  0/53 (0.00%) 
Pregnancy test positive  1  1/132 (0.76%)  0/53 (0.00%) 
Total lung capacity decreased  1  1/132 (0.76%)  0/53 (0.00%) 
Transaminases increased  1  1/132 (0.76%)  0/53 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/132 (0.76%)  0/53 (0.00%) 
Dehydration  1  4/132 (3.03%)  1/53 (1.89%) 
Hyponatraemia  1  1/132 (0.76%)  0/53 (0.00%) 
Iron overload  1  1/132 (0.76%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/132 (2.27%)  2/53 (3.77%) 
Back pain  1  6/132 (4.55%)  5/53 (9.43%) 
Bone pain  1  1/132 (0.76%)  0/53 (0.00%) 
Bursitis  1  1/132 (0.76%)  0/53 (0.00%) 
Costochondritis  1  0/132 (0.00%)  1/53 (1.89%) 
Flank pain  1  1/132 (0.76%)  0/53 (0.00%) 
Muscular weakness  1  1/132 (0.76%)  0/53 (0.00%) 
Musculoskeletal pain  1  3/132 (2.27%)  0/53 (0.00%) 
Osteolysis  1  1/132 (0.76%)  0/53 (0.00%) 
Osteonecrosis  1  4/132 (3.03%)  0/53 (0.00%) 
Pain in extremity  1  6/132 (4.55%)  3/53 (5.66%) 
Rheumatoid arthritis  1  0/132 (0.00%)  1/53 (1.89%) 
Rotator cuff syndrome  1  1/132 (0.76%)  0/53 (0.00%) 
Synovial cyst  1  1/132 (0.76%)  0/53 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic myeloid leukaemia  1  1/132 (0.76%)  0/53 (0.00%) 
Lung neoplasm  1  0/132 (0.00%)  1/53 (1.89%) 
Nervous system disorders     
Altered state of consciousness  1  1/132 (0.76%)  0/53 (0.00%) 
Complex partial seizures  1  1/132 (0.76%)  0/53 (0.00%) 
Convulsion  1  3/132 (2.27%)  1/53 (1.89%) 
Dizziness  1  1/132 (0.76%)  0/53 (0.00%) 
Encephalopathy  1  1/132 (0.76%)  0/53 (0.00%) 
Facial palsy  1  1/132 (0.76%)  0/53 (0.00%) 
Haemorrhage intracranial  1  1/132 (0.76%)  0/53 (0.00%) 
Headache  1  7/132 (5.30%)  2/53 (3.77%) 
Hepatic encephalopathy  1  1/132 (0.76%)  0/53 (0.00%) 
Hypoaesthesia  1  2/132 (1.52%)  0/53 (0.00%) 
Intraventricular haemorrhage  1  1/132 (0.76%)  2/53 (3.77%) 
Migraine  1  2/132 (1.52%)  0/53 (0.00%) 
Paraesthesia  1  1/132 (0.76%)  0/53 (0.00%) 
Syncope  1  3/132 (2.27%)  0/53 (0.00%) 
Transient ischaemic attack  1  3/132 (2.27%)  0/53 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/132 (0.76%)  1/53 (1.89%) 
Pregnancy  1  3/132 (2.27%)  1/53 (1.89%) 
Psychiatric disorders     
Abnormal behaviour  1  1/132 (0.76%)  0/53 (0.00%) 
Conversion disorder  1  1/132 (0.76%)  0/53 (0.00%) 
Mental status changes  1  1/132 (0.76%)  0/53 (0.00%) 
Renal and urinary disorders     
Enuresis  1  1/132 (0.76%)  0/53 (0.00%) 
Haematuria  1  0/132 (0.00%)  1/53 (1.89%) 
Nephropathy toxic  1  0/132 (0.00%)  1/53 (1.89%) 
Oliguria  1  1/132 (0.76%)  0/53 (0.00%) 
Renal failure acute  1  2/132 (1.52%)  0/53 (0.00%) 
Reproductive system and breast disorders     
Breast swelling  1  1/132 (0.76%)  0/53 (0.00%) 
Epididymitis  1  1/132 (0.76%)  0/53 (0.00%) 
Priapism  1  3/132 (2.27%)  1/53 (1.89%) 
Vaginal haemorrhage  1  0/132 (0.00%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/132 (0.76%)  0/53 (0.00%) 
Cough  1  4/132 (3.03%)  0/53 (0.00%) 
Dyspnoea  1  4/132 (3.03%)  1/53 (1.89%) 
Epistaxis  1  1/132 (0.76%)  0/53 (0.00%) 
Lung infiltration  1  1/132 (0.76%)  0/53 (0.00%) 
Oropharyngeal pain  1  1/132 (0.76%)  0/53 (0.00%) 
Pleural effusion  1  1/132 (0.76%)  0/53 (0.00%) 
Pneumonitis  1  1/132 (0.76%)  0/53 (0.00%) 
Productive cough  1  1/132 (0.76%)  0/53 (0.00%) 
Pulmonary hypertension  1  0/132 (0.00%)  2/53 (3.77%) 
Pulmonary thrombosis  1  1/132 (0.76%)  0/53 (0.00%) 
Respiratory failure  1  1/132 (0.76%)  0/53 (0.00%) 
Respiratory tract congestion  1  1/132 (0.76%)  0/53 (0.00%) 
Wheezing  1  1/132 (0.76%)  0/53 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  2/132 (1.52%)  0/53 (0.00%) 
Swelling face  1  1/132 (0.76%)  0/53 (0.00%) 
Surgical and medical procedures     
Catheter placement  1  1/132 (0.76%)  0/53 (0.00%) 
Catheter removal  1  1/132 (0.76%)  0/53 (0.00%) 
Central venous catheterisation  1  1/132 (0.76%)  0/53 (0.00%) 
Cholecystectomy  1  1/132 (0.76%)  0/53 (0.00%) 
Hip arthroplasty  1  1/132 (0.76%)  0/53 (0.00%) 
Vascular disorders     
Haematoma  1  1/132 (0.76%)  0/53 (0.00%) 
Hypotension  1  1/132 (0.76%)  0/53 (0.00%) 
Jugular vein distension  1  1/132 (0.76%)  0/53 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ICL670 Crossover
Affected / at Risk (%) Affected / at Risk (%)
Total   129/132 (97.73%)   47/53 (88.68%) 
Blood and lymphatic system disorders     
Leukocytosis  1  4/132 (3.03%)  3/53 (5.66%) 
Lymphadenopathy  1  8/132 (6.06%)  2/53 (3.77%) 
Cardiac disorders     
Tachycardia  1  2/132 (1.52%)  3/53 (5.66%) 
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis  1  37/132 (28.03%)  13/53 (24.53%) 
Ear and labyrinth disorders     
Ear pain  1  8/132 (6.06%)  3/53 (5.66%) 
Eye disorders     
Ocular icterus  1  11/132 (8.33%)  6/53 (11.32%) 
Vision blurred  1  9/132 (6.82%)  5/53 (9.43%) 
Gastrointestinal disorders     
Abdominal discomfort  1  9/132 (6.82%)  2/53 (3.77%) 
Abdominal pain  1  32/132 (24.24%)  13/53 (24.53%) 
Abdominal pain upper  1  27/132 (20.45%)  15/53 (28.30%) 
Constipation  1  28/132 (21.21%)  7/53 (13.21%) 
Diarrhoea  1  39/132 (29.55%)  19/53 (35.85%) 
Dyspepsia  1  8/132 (6.06%)  3/53 (5.66%) 
Gastrooesophageal reflux disease  1  2/132 (1.52%)  3/53 (5.66%) 
Nausea  1  52/132 (39.39%)  19/53 (35.85%) 
Toothache  1  9/132 (6.82%)  4/53 (7.55%) 
Vomiting  1  45/132 (34.09%)  17/53 (32.08%) 
General disorders     
Asthenia  1  7/132 (5.30%)  1/53 (1.89%) 
Chest pain  1  24/132 (18.18%)  15/53 (28.30%) 
Chills  1  9/132 (6.82%)  4/53 (7.55%) 
Fatigue  1  22/132 (16.67%)  7/53 (13.21%) 
Oedema peripheral  1  14/132 (10.61%)  4/53 (7.55%) 
Pain  1  16/132 (12.12%)  6/53 (11.32%) 
Pyrexia  1  45/132 (34.09%)  22/53 (41.51%) 
Hepatobiliary disorders     
Jaundice  1  6/132 (4.55%)  3/53 (5.66%) 
Infections and infestations     
Bronchitis  1  8/132 (6.06%)  1/53 (1.89%) 
Cellulitis  1  2/132 (1.52%)  3/53 (5.66%) 
Ear infection  1  9/132 (6.82%)  1/53 (1.89%) 
Gastroenteritis  1  12/132 (9.09%)  3/53 (5.66%) 
Gastroenteritis viral  1  8/132 (6.06%)  4/53 (7.55%) 
Influenza  1  14/132 (10.61%)  4/53 (7.55%) 
Nasopharyngitis  1  37/132 (28.03%)  16/53 (30.19%) 
Oral herpes  1  8/132 (6.06%)  1/53 (1.89%) 
Pharyngitis  1  12/132 (9.09%)  4/53 (7.55%) 
Pharyngitis streptococcal  1  7/132 (5.30%)  4/53 (7.55%) 
Pneumonia  1  2/132 (1.52%)  3/53 (5.66%) 
Rhinitis  1  9/132 (6.82%)  0/53 (0.00%) 
Sinusitis  1  17/132 (12.88%)  5/53 (9.43%) 
Staphylococcal infection  1  7/132 (5.30%)  1/53 (1.89%) 
Tonsillitis  1  7/132 (5.30%)  1/53 (1.89%) 
Upper respiratory tract infection  1  43/132 (32.58%)  19/53 (35.85%) 
Urinary tract infection  1  20/132 (15.15%)  3/53 (5.66%) 
Viral infection  1  11/132 (8.33%)  1/53 (1.89%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  1/132 (0.76%)  3/53 (5.66%) 
Excoriation  1  8/132 (6.06%)  0/53 (0.00%) 
Skin laceration  1  4/132 (3.03%)  3/53 (5.66%) 
Transfusion reaction  1  8/132 (6.06%)  2/53 (3.77%) 
Investigations     
Alanine aminotransferase increased  1  6/132 (4.55%)  4/53 (7.55%) 
Aspartate aminotransferase increased  1  8/132 (6.06%)  3/53 (5.66%) 
Blood creatinine increased  1  12/132 (9.09%)  4/53 (7.55%) 
Serum ferritin increased  1  8/132 (6.06%)  4/53 (7.55%) 
Transaminases increased  1  9/132 (6.82%)  1/53 (1.89%) 
Metabolism and nutrition disorders     
Decreased appetite  1  7/132 (5.30%)  3/53 (5.66%) 
Dehydration  1  5/132 (3.79%)  4/53 (7.55%) 
Vitamin D deficiency  1  8/132 (6.06%)  5/53 (9.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  36/132 (27.27%)  14/53 (26.42%) 
Back pain  1  48/132 (36.36%)  15/53 (28.30%) 
Bone pain  1  9/132 (6.82%)  0/53 (0.00%) 
Muscle spasms  1  10/132 (7.58%)  1/53 (1.89%) 
Muscular weakness  1  5/132 (3.79%)  3/53 (5.66%) 
Musculoskeletal pain  1  12/132 (9.09%)  9/53 (16.98%) 
Myalgia  1  6/132 (4.55%)  4/53 (7.55%) 
Neck pain  1  3/132 (2.27%)  4/53 (7.55%) 
Pain in extremity  1  41/132 (31.06%)  13/53 (24.53%) 
Nervous system disorders     
Dizziness  1  17/132 (12.88%)  7/53 (13.21%) 
Headache  1  61/132 (46.21%)  30/53 (56.60%) 
Hypoaesthesia  1  7/132 (5.30%)  1/53 (1.89%) 
Migraine  1  7/132 (5.30%)  4/53 (7.55%) 
Psychiatric disorders     
Anxiety  1  7/132 (5.30%)  3/53 (5.66%) 
Depression  1  10/132 (7.58%)  0/53 (0.00%) 
Insomnia  1  13/132 (9.85%)  2/53 (3.77%) 
Renal and urinary disorders     
Chromaturia  1  3/132 (2.27%)  3/53 (5.66%) 
Proteinuria  1  7/132 (5.30%)  0/53 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  10/132 (7.58%)  4/53 (7.55%) 
Ovarian cyst  1  1/132 (0.76%)  3/53 (5.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  35/132 (26.52%)  14/53 (26.42%) 
Dyspnoea  1  12/132 (9.09%)  6/53 (11.32%) 
Epistaxis  1  8/132 (6.06%)  4/53 (7.55%) 
Nasal congestion  1  22/132 (16.67%)  9/53 (16.98%) 
Oropharyngeal pain  1  40/132 (30.30%)  15/53 (28.30%) 
Rhinitis allergic  1  6/132 (4.55%)  3/53 (5.66%) 
Rhinorrhoea  1  9/132 (6.82%)  4/53 (7.55%) 
Skin and subcutaneous tissue disorders     
Acne  1  5/132 (3.79%)  3/53 (5.66%) 
Pruritus  1  16/132 (12.12%)  3/53 (5.66%) 
Rash  1  21/132 (15.91%)  9/53 (16.98%) 
Rash papular  1  7/132 (5.30%)  1/53 (1.89%) 
Urticaria  1  9/132 (6.82%)  4/53 (7.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01090323     History of Changes
Obsolete Identifiers: NCT00171197
Other Study ID Numbers: CICL670A0109E1
EudraCT no. 2004-000597-31 ( Registry Identifier: EudraCT )
First Submitted: March 15, 2010
First Posted: March 19, 2010
Results First Submitted: December 21, 2010
Results First Posted: January 20, 2011
Last Update Posted: June 6, 2011