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Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma

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ClinicalTrials.gov Identifier: NCT00154375
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : February 2, 2011
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma Multiforme
Astrocytoma
Interventions Drug: Imatinib mesylate
Drug: Hydroxyurea
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Imatinib Mesylate + Hydroxyurea (HU) Hydroxyurea Alone
Hide Arm/Group Description Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. 1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
Period Title: Overall Study
Started 120 120
Discontinued Study Treatment 111 104
Not Exposed to Study Treatment 2 [1] 2
Completed 7 14
Not Completed 113 106
Reason Not Completed
Unsatisfactory therapeutic effect             25             26
Adverse Event             18             20
Withdrawal by Subject             14             10
Death             5             13
Study drug no longer required             5             3
Lost to Follow-up             2             1
Abnormal laboratory value(s)             0             2
Protocol Violation             0             1
Suspected progression of disease             44             30
[1]
4 randomized patients didn't receive study treatment were excluded from the safety analyses.
Arm/Group Title Imatinib Mesylate + Hydroxyurea (HU) Hydroxyurea Alone Total
Hide Arm/Group Description Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. 1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea. Total of all reporting groups
Overall Number of Baseline Participants 120 120 240
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 120 participants 240 participants
52.1  (11.3) 50.2  (11.4) 51.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
Female
50
  41.7%
38
  31.7%
88
  36.7%
Male
70
  58.3%
82
  68.3%
152
  63.3%
1.Primary Outcome
Title Percentage of Participants With Progression Free Survival (PFS) During the Study Duration
Hide Description PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).
Time Frame 6 months -1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consists of all randomized patients, analyzed according to their randomized treatment.
Arm/Group Title Imatinib Mesylate + Hydroxyurea (HU) Hydroxyurea Alone
Hide Arm/Group Description:
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
Overall Number of Participants Analyzed 120 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
6 months
5.3
(1.0 to 9.7)
6.6
(2.1 to 11.1)
12 months
2.1
(0.0 to 5.0)
2.1
(0.0 to 5.5)
2.Secondary Outcome
Title Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations
Hide Description National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
Time Frame 6 months - 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of randomized patients with at least one dose of randomized medication.
Arm/Group Title Imatinib Mesylate + Hydroxyurea (HU) Hydroxyurea Alone
Hide Arm/Group Description:
Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
Overall Number of Participants Analyzed 118 118
Measure Type: Number
Unit of Measure: Participants
Deaths 84 91
Death due to disease progression 76 77
Serious Adverse Events (SAEs) 64 79
NCI/NIH Grade 3 (severe) or 4 (life threatening) 54 64
Suspected to be drug-related 12 12
Leading to dose adjustment or interruption 6 16
Leading to permanent discontinuation 9 13
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population = patients who were randomized to either Imatinib + Hydroxyurea (combination)[n=118] or to Hydroxyurea alone [n=118]. Every 6 wks, patients on Hydroxyurea alone switched to combination arm depending on response. So, for the safety analysis Hydroxyurea arm is divided into Hydroxyurea alone [n=118] or switch to combination [n=85].
 
Arm/Group Title Imatinib Mesylate + Hydroxyurea (HU) Period With Hydroxyurea Alone Period After Switch to Combination
Hide Arm/Group Description Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. 1500 mg/day of HU given as 500 mg 3 times daily. After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
All-Cause Mortality
Imatinib Mesylate + Hydroxyurea (HU) Period With Hydroxyurea Alone Period After Switch to Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Imatinib Mesylate + Hydroxyurea (HU) Period With Hydroxyurea Alone Period After Switch to Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/118 (54.24%)   46/118 (38.98%)   49/85 (57.65%) 
Blood and lymphatic system disorders       
ANAEMIA  1  2/118 (1.69%)  0/118 (0.00%)  0/85 (0.00%) 
LEUKOPENIA  1  1/118 (0.85%)  2/118 (1.69%)  5/85 (5.88%) 
NEUTROPENIA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
THROMBOCYTOPENIA  1  3/118 (2.54%)  0/118 (0.00%)  2/85 (2.35%) 
Cardiac disorders       
CARDIAC FAILURE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Eye disorders       
VISUAL ACUITY REDUCED  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
VISUAL DISTURBANCE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  2/118 (1.69%)  0/118 (0.00%)  1/85 (1.18%) 
DYSPHAGIA  1  1/118 (0.85%)  0/118 (0.00%)  1/85 (1.18%) 
NAUSEA  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
STOMATITIS  1  2/118 (1.69%)  0/118 (0.00%)  0/85 (0.00%) 
VOMITING  1  1/118 (0.85%)  2/118 (1.69%)  0/85 (0.00%) 
General disorders       
APLASIA  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
ASTHENIA  1  0/118 (0.00%)  1/118 (0.85%)  1/85 (1.18%) 
CHEST PAIN  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
DEATH  1  1/118 (0.85%)  1/118 (0.85%)  2/85 (2.35%) 
FATIGUE  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  7/118 (5.93%)  6/118 (5.08%)  2/85 (2.35%) 
NECROSIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
OEDEMA PERIPHERAL  1  1/118 (0.85%)  0/118 (0.00%)  1/85 (1.18%) 
PAIN  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PERFORMANCE STATUS DECREASED  1  1/118 (0.85%)  1/118 (0.85%)  0/85 (0.00%) 
PYREXIA  1  1/118 (0.85%)  1/118 (0.85%)  1/85 (1.18%) 
SUDDEN DEATH  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
Infections and infestations       
ASPERGILLOSIS  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
BRONCHITIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
GASTROENTERITIS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
HERPES ZOSTER  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
INJECTION SITE ABSCESS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PNEUMONIA  1  9/118 (7.63%)  4/118 (3.39%)  5/85 (5.88%) 
PNEUMONIA PRIMARY ATYPICAL  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
PULMONARY SEPSIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
SEPSIS  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
SINUSITIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
STAPHYLOCOCCAL BACTERAEMIA  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
SUBCUTANEOUS ABSCESS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
URINARY TRACT INFECTION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
VULVITIS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Injury, poisoning and procedural complications       
BRAIN CONTUSION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
FALL  1  3/118 (2.54%)  1/118 (0.85%)  3/85 (3.53%) 
HEAD INJURY  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
RADIUS FRACTURE  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
SUBDURAL HAEMATOMA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
SUBDURAL HAEMORRHAGE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
THORACIC VERTEBRAL FRACTURE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
BLOOD LACTATE DEHYDROGENASE INCREASED  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
GENERAL PHYSICAL CONDITION ABNORMAL  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
HEPATIC ENZYME INCREASED  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
HYPERGLYCAEMIA  1  2/118 (1.69%)  2/118 (1.69%)  0/85 (0.00%) 
HYPOKALAEMIA  1  1/118 (0.85%)  0/118 (0.00%)  1/85 (1.18%) 
HYPONATRAEMIA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
BACK PAIN  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
BURSITIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
MUSCLE SPASMS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
MUSCULAR WEAKNESS  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
INTRACRANIAL TUMOUR HAEMORRHAGE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
NEOPLASM PROGRESSION  1  4/118 (3.39%)  0/118 (0.00%)  1/85 (1.18%) 
Nervous system disorders       
ALTERED STATE OF CONSCIOUSNESS  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
APHASIA  1  4/118 (3.39%)  0/118 (0.00%)  0/85 (0.00%) 
APRAXIA  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
BALANCE DISORDER  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
BRAIN OEDEMA  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
CEREBRAL HAEMORRHAGE  1  1/118 (0.85%)  0/118 (0.00%)  1/85 (1.18%) 
CONVULSION  1  3/118 (2.54%)  4/118 (3.39%)  4/85 (4.71%) 
COORDINATION ABNORMAL  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
DEMENTIA  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
DISTURBANCE IN ATTENTION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
DIZZINESS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
DYSPHASIA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
EPILEPSY  1  5/118 (4.24%)  9/118 (7.63%)  9/85 (10.59%) 
HEADACHE  1  2/118 (1.69%)  5/118 (4.24%)  3/85 (3.53%) 
HEMIPARESIS  1  8/118 (6.78%)  5/118 (4.24%)  2/85 (2.35%) 
HEMIPLEGIA  1  1/118 (0.85%)  2/118 (1.69%)  0/85 (0.00%) 
INTRACRANIAL PRESSURE INCREASED  1  3/118 (2.54%)  3/118 (2.54%)  4/85 (4.71%) 
LOSS OF CONSCIOUSNESS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
NERVOUS SYSTEM DISORDER  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
PARESIS  1  1/118 (0.85%)  1/118 (0.85%)  1/85 (1.18%) 
PARTIAL SEIZURES  1  1/118 (0.85%)  2/118 (1.69%)  4/85 (4.71%) 
PSYCHOMOTOR SKILLS IMPAIRED  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
SOMNOLENCE  1  2/118 (1.69%)  1/118 (0.85%)  0/85 (0.00%) 
SPEECH DISORDER  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Psychiatric disorders       
ABNORMAL BEHAVIOUR  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
AGITATION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
ANXIETY  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
CONFUSIONAL STATE  1  4/118 (3.39%)  0/118 (0.00%)  1/85 (1.18%) 
HALLUCINATION  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
MENTAL DISORDER  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PERSONALITY DISORDER  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Renal and urinary disorders       
INCONTINENCE  1  0/118 (0.00%)  0/118 (0.00%)  2/85 (2.35%) 
OLIGURIA  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
RENAL COLIC  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  3/118 (2.54%)  3/118 (2.54%)  2/85 (2.35%) 
EPISTAXIS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PLEURAL EFFUSION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PNEUMONIA ASPIRATION  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
PNEUMONITIS  1  0/118 (0.00%)  0/118 (0.00%)  1/85 (1.18%) 
PULMONARY EMBOLISM  1  1/118 (0.85%)  1/118 (0.85%)  2/85 (2.35%) 
RESPIRATORY FAILURE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Skin and subcutaneous tissue disorders       
DECUBITUS ULCER  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
Surgical and medical procedures       
BRAIN LOBECTOMY  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
CYSTOSTOMY  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
TUMOUR EXCISION  1  3/118 (2.54%)  0/118 (0.00%)  0/85 (0.00%) 
Vascular disorders       
CIRCULATORY COLLAPSE  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
DEEP VEIN THROMBOSIS  1  1/118 (0.85%)  0/118 (0.00%)  0/85 (0.00%) 
HYPERTENSION  1  0/118 (0.00%)  1/118 (0.85%)  0/85 (0.00%) 
THROMBOSIS  1  0/118 (0.00%)  1/118 (0.85%)  1/85 (1.18%) 
VENOUS THROMBOSIS  1  1/118 (0.85%)  0/118 (0.00%)  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imatinib Mesylate + Hydroxyurea (HU) Period With Hydroxyurea Alone Period After Switch to Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/118 (88.14%)   80/118 (67.80%)   65/85 (76.47%) 
Blood and lymphatic system disorders       
ANAEMIA  1  13/118 (11.02%)  8/118 (6.78%)  13/85 (15.29%) 
LEUKOPENIA  1  16/118 (13.56%)  14/118 (11.86%)  14/85 (16.47%) 
THROMBOCYTOPENIA  1  24/118 (20.34%)  15/118 (12.71%)  17/85 (20.00%) 
Endocrine disorders       
CUSHINGOID  1  6/118 (5.08%)  1/118 (0.85%)  5/85 (5.88%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  6/118 (5.08%)  3/118 (2.54%)  2/85 (2.35%) 
ABDOMINAL PAIN UPPER  1  7/118 (5.93%)  1/118 (0.85%)  0/85 (0.00%) 
CONSTIPATION  1  11/118 (9.32%)  4/118 (3.39%)  5/85 (5.88%) 
DIARRHOEA  1  11/118 (9.32%)  4/118 (3.39%)  4/85 (4.71%) 
DYSPEPSIA  1  2/118 (1.69%)  6/118 (5.08%)  2/85 (2.35%) 
NAUSEA  1  28/118 (23.73%)  17/118 (14.41%)  10/85 (11.76%) 
VOMITING  1  21/118 (17.80%)  13/118 (11.02%)  6/85 (7.06%) 
General disorders       
ASTHENIA  1  11/118 (9.32%)  6/118 (5.08%)  9/85 (10.59%) 
FATIGUE  1  34/118 (28.81%)  16/118 (13.56%)  18/85 (21.18%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  10/118 (8.47%)  8/118 (6.78%)  4/85 (4.71%) 
OEDEMA PERIPHERAL  1  29/118 (24.58%)  12/118 (10.17%)  14/85 (16.47%) 
PYREXIA  1  6/118 (5.08%)  1/118 (0.85%)  2/85 (2.35%) 
Injury, poisoning and procedural complications       
FALL  1  4/118 (3.39%)  3/118 (2.54%)  5/85 (5.88%) 
Investigations       
BLOOD LACTATE DEHYDROGENASE INCREASED  1  6/118 (5.08%)  6/118 (5.08%)  1/85 (1.18%) 
Metabolism and nutrition disorders       
ANOREXIA  1  6/118 (5.08%)  2/118 (1.69%)  1/85 (1.18%) 
HYPOKALAEMIA  1  14/118 (11.86%)  2/118 (1.69%)  6/85 (7.06%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  6/118 (5.08%)  3/118 (2.54%)  4/85 (4.71%) 
BACK PAIN  1  4/118 (3.39%)  2/118 (1.69%)  6/85 (7.06%) 
MUSCULAR WEAKNESS  1  13/118 (11.02%)  5/118 (4.24%)  3/85 (3.53%) 
PAIN IN EXTREMITY  1  6/118 (5.08%)  4/118 (3.39%)  2/85 (2.35%) 
Nervous system disorders       
AMNESIA  1  8/118 (6.78%)  2/118 (1.69%)  4/85 (4.71%) 
APHASIA  1  9/118 (7.63%)  4/118 (3.39%)  5/85 (5.88%) 
CONVULSION  1  6/118 (5.08%)  2/118 (1.69%)  6/85 (7.06%) 
COORDINATION ABNORMAL  1  9/118 (7.63%)  9/118 (7.63%)  6/85 (7.06%) 
DIZZINESS  1  16/118 (13.56%)  3/118 (2.54%)  7/85 (8.24%) 
EPILEPSY  1  13/118 (11.02%)  3/118 (2.54%)  3/85 (3.53%) 
HEADACHE  1  26/118 (22.03%)  24/118 (20.34%)  16/85 (18.82%) 
HEMIPARESIS  1  10/118 (8.47%)  7/118 (5.93%)  7/85 (8.24%) 
LETHARGY  1  6/118 (5.08%)  5/118 (4.24%)  1/85 (1.18%) 
SOMNOLENCE  1  7/118 (5.93%)  2/118 (1.69%)  1/85 (1.18%) 
Psychiatric disorders       
CONFUSIONAL STATE  1  9/118 (7.63%)  4/118 (3.39%)  3/85 (3.53%) 
DEPRESSION  1  3/118 (2.54%)  2/118 (1.69%)  6/85 (7.06%) 
INSOMNIA  1  4/118 (3.39%)  1/118 (0.85%)  5/85 (5.88%) 
SLEEP DISORDER  1  6/118 (5.08%)  4/118 (3.39%)  2/85 (2.35%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  7/118 (5.93%)  3/118 (2.54%)  4/85 (4.71%) 
Skin and subcutaneous tissue disorders       
RASH  1  8/118 (6.78%)  2/118 (1.69%)  0/85 (0.00%) 
Vascular disorders       
THROMBOSIS  1  1/118 (0.85%)  0/118 (0.00%)  5/85 (5.88%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00154375    
Other Study ID Numbers: CSTI571BDE40
First Submitted: September 9, 2005
First Posted: September 12, 2005
Results First Submitted: January 13, 2011
Results First Posted: February 2, 2011
Last Update Posted: April 26, 2011