ENESTg1: A Study of Nilotinib Versus Imatinib in GIST Patients

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00785785
Collaborator
(none)
644
Enrollment
165
Locations
2
Arms
67
Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Nilotinib (AMN107)
  • Drug: imatinib (STI571)
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
644 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

ArmIntervention/Treatment
Experimental: Nilotinib

nilotinib 400 mg twice a day

Drug: Nilotinib (AMN107)

Active Comparator: Imatinib

imatinib 400 mg once daily

Drug: imatinib (STI571)
Other Names:
  • Glivec/Gleevec
  • Outcome Measures

    Primary Outcome Measures

    1. Time to Progression Free Survival (PFS) [up to month 37]

      PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
    • have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or

    • recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.

    1. At least one measurable site of disease on CT/MRI scan

    2. Performance status ≤ 2 (capable of self-care but unable to carry out any work)

    3. Normal organ, electrolyte and marrow function

    Exclusion Criteria:
    1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.

    2. Disease progression during adjuvant therapy with imatinib

    3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.

    4. Impaired cardiac function

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Birmingham Hematology and Oncology AssociatesBirminghamAlabamaUnited States35205
    2Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-OncFlagstaffArizonaUnited States86001
    3City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)DuarteCaliforniaUnited States91010-3000
    4City of Hope National Medical Center Regulatory DocumentDuarteCaliforniaUnited States91010-3000
    5University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)La JollaCaliforniaUnited States92093-0658
    6University of California at Los Angeles GI Oncology ProgramLos AngelesCaliforniaUnited States90095
    7Stanford University Medical Center Stanford Cancer CenterStanfordCaliforniaUnited States94304
    8University of Colorado Dept. of Univ. of ColoradoAuroraColoradoUnited States80045
    9Rocky Mountain Cancer Centers Dept. of Rocky Mountain CancerGreenwood VillageColoradoUnited States
    10Washington Hospital Center Wash HospitalWashingtonDistrict of ColumbiaUnited States20010
    11Ocala Oncology Center Dept. of Ocala Oncology CenterOcalaFloridaUnited States34474
    12Kootenai Medical Center Dept.ofKootenai Med.Ctr.Coeur d'AleneIdahoUnited States83814
    13Northwestern University Clinical Research Office (2)ChicagoIllinoisUnited States60611
    14Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncologyBostonMassachusettsUnited States02215
    15University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)Ann ArborMichiganUnited States48109-0944
    16Minnesota Oncology Hematology, P.A. SCMinneapolisMinnesotaUnited States55404
    17Mayo Clinic - Rochester Division of HematologyRochesterMinnesotaUnited States55905
    18New York Oncology Hematology, P.C. NYOH AmsterdamTroyNew YorkUnited States12180
    19New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)TroyNew YorkUnited States12180
    20University of Pennsylvania Medical Center CAMN107G2301PhiladelphiaPennsylvaniaUnited States19104-4283
    21Vanderbilt Univeristy Ingram Cancer Ctr.NashvilleTennesseeUnited States37232
    22Texas Oncology, P.A. Tex Onc (2)BedfordTexasUnited States76022
    23Texas Oncology Wichita FallsDallasTexasUnited States75246
    24University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)DallasTexasUnited States75390-8527
    25University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)HoustonTexasUnited States77030-4009
    26Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)San AntonioTexasUnited States78229
    27Tyler Cancer Center Dept.ofTylerCancerCtr. (2)TylerTexasUnited States75702
    28University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)Salt Lake CityUtahUnited States84112
    29Novartis Investigative SiteCabaBuenos AiresArgentinaC1426ANZ
    30Novartis Investigative SiteRosarioSanta FeArgentinaS2000PBH
    31Novartis Investigative SiteBuenos AiresArgentinaC1264AAA
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    145Novartis Investigative SiteTaipeiTaiwan, ROCTaiwan112
    146Novartis Investigative SiteLin-KouTaiwan33305
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    159Novartis Investigative SiteCambridgeUnited KingdomCB2 2QQ
    160Novartis Investigative SiteGlasgowUnited KingdomG12 0YN
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    165Novartis Investigative SiteCaracasDistrito CapitalVenezuela1010

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00785785
    Other Study ID Numbers:
    • CAMN107G2301
    • 2008-004758-34
    First Posted:
    Nov 5, 2008
    Last Update Posted:
    Jun 16, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleImatinib First, Then NilotinibNilotinib First, Then Imatinib
    Arm/Group Descriptionpatients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phasepatients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
    Period Title: Core Phase up to 36 Months
    STARTED324320
    COMPLETED00
    NOT COMPLETED324320
    Period Title: Core Phase up to 36 Months
    STARTED39125
    COMPLETED00
    NOT COMPLETED39125

    Baseline Characteristics

    Arm/Group TitleImatinib First, Then NilotinibNilotinib First, Then ImatinibTotal
    Arm/Group Descriptionpatients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phasepatients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once dailyTotal of all reporting groups
    Overall Participants324320644
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.4
    (12.91)
    57.3
    (12.63)
    57.35
    (12.77)
    Sex: Female, Male (Count of Participants)
    Female
    145
    44.8%
    133
    41.6%
    278
    43.2%
    Male
    179
    55.2%
    187
    58.4%
    366
    56.8%

    Outcome Measures

    1. Primary Outcome
    TitleTime to Progression Free Survival (PFS)
    DescriptionPFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
    Time Frameup to month 37

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.
    Arm/Group TitleNilotinibImatinib
    Arm/Group Descriptionnilotinib 400 mg twice a dayimatinib 400 mg once daily
    Measure Participants324320
    Median (Full Range) [months]
    25.9
    29.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Nilotinib, Imatinib
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesisp-Value0.0081
    Comments
    MethodHazard Ratio
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.466
    Confidence Interval (2-Sided) 95%
    1.104 to 1.945
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleNilotinibImatinibCrossover NilotinibCrossover Imatinib
    Arm/Group DescriptionExposure to Nilotinib onlyExposure to Imatinib onlyexposure to imatinib and then nilotinibexposure to nilotinib and then imatinib
    All Cause Mortality
    NilotinibImatinibCrossover NilotinibCrossover Imatinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    NilotinibImatinibCrossover NilotinibCrossover Imatinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total80/321 (24.9%) 85/316 (26.9%) 15/39 (38.5%) 26/125 (20.8%)
    Blood and lymphatic system disorders
    Anaemia6/321 (1.9%) 3/316 (0.9%) 2/39 (5.1%) 3/125 (2.4%)
    Febrile neutropenia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Neutropenia1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Thrombocytopenia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Cardiac disorders
    Acute myocardial infarction2/321 (0.6%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Angina pectoris2/321 (0.6%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Angina unstable1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Arrhythmia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Atrial fibrillation0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Cardiac arrest1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cardiac failure0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Cardiac failure congestive1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cardio-respiratory arrest0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Mitral valve stenosis0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Myocardial infarction1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Palpitations1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Pericardial effusion2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Supraventricular tachycardia0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Congenital, familial and genetic disorders
    Dermoid cyst0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastrointestinal disorders
    Abdominal distension0/321 (0%) 1/316 (0.3%) 0/39 (0%) 1/125 (0.8%)
    Abdominal hernia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Abdominal mass0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Abdominal pain15/321 (4.7%) 12/316 (3.8%) 4/39 (10.3%) 3/125 (2.4%)
    Abdominal pain upper1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Anal fissure1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Anal fistula0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Ascites2/321 (0.6%) 1/316 (0.3%) 0/39 (0%) 2/125 (1.6%)
    Colonic fistula0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Constipation3/321 (0.9%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Diarrhoea1/321 (0.3%) 4/316 (1.3%) 0/39 (0%) 2/125 (1.6%)
    Faecaloma0/321 (0%) 1/316 (0.3%) 0/39 (0%) 1/125 (0.8%)
    Gastric ulcer0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastric ulcer haemorrhage0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastritis2/321 (0.6%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastritis haemorrhagic0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastrointestinal haemorrhage5/321 (1.6%) 5/316 (1.6%) 1/39 (2.6%) 0/125 (0%)
    Gastrointestinal obstruction1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Gastrooesophageal reflux disease1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Haematemesis1/321 (0.3%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Haematochezia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Haemorrhoids0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Ileus2/321 (0.6%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Intestinal obstruction4/321 (1.2%) 2/316 (0.6%) 1/39 (2.6%) 3/125 (2.4%)
    Intestinal perforation0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Intra-abdominal haemorrhage0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Jejunal perforation0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Large intestinal stenosis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Mechanical ileus1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Nausea2/321 (0.6%) 2/316 (0.6%) 0/39 (0%) 1/125 (0.8%)
    Peptic ulcer0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Small intestinal haemorrhage0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Subileus2/321 (0.6%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Upper gastrointestinal haemorrhage1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Vomiting5/321 (1.6%) 3/316 (0.9%) 1/39 (2.6%) 4/125 (3.2%)
    General disorders
    Asthenia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Death0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Disease progression0/321 (0%) 0/316 (0%) 1/39 (2.6%) 1/125 (0.8%)
    Face oedema1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Fatigue0/321 (0%) 2/316 (0.6%) 0/39 (0%) 1/125 (0.8%)
    General physical health deterioration0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Generalised oedema0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Multi-organ failure1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 1/125 (0.8%)
    Oedema mucosal1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Oedema peripheral1/321 (0.3%) 3/316 (0.9%) 1/39 (2.6%) 0/125 (0%)
    Pain0/321 (0%) 0/316 (0%) 2/39 (5.1%) 1/125 (0.8%)
    Performance status decreased1/321 (0.3%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Pyrexia2/321 (0.6%) 6/316 (1.9%) 0/39 (0%) 3/125 (2.4%)
    Hepatobiliary disorders
    Bile duct obstruction1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Cholangitis2/321 (0.6%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Hepatic failure1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Hepatic function abnormal1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Hepatic pain0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Hyperbilirubinaemia0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Jaundice1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Jaundice cholestatic1/321 (0.3%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Portal hypertension0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Immune system disorders
    Hypersensitivity1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Infections and infestations
    Abdominal infection1/321 (0.3%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Abdominal wall abscess0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Appendicitis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Bacterial sepsis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Bronchitis0/321 (0%) 1/316 (0.3%) 1/39 (2.6%) 0/125 (0%)
    Cellulitis1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Ear infection0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Eye infection0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Gastroenteritis2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Helicobacter gastritis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Infection1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Infectious pleural effusion1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Lung infection0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Periodontitis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Peritonitis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Pneumonia3/321 (0.9%) 4/316 (1.3%) 1/39 (2.6%) 1/125 (0.8%)
    Post procedural infection0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Postoperative wound infection0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Respiratory tract infection0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Sepsis2/321 (0.6%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Septic shock1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Upper respiratory tract infection1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Urinary tract infection4/321 (1.2%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Viral infection0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Fall0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Femur fracture0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Fracture0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Multiple fractures0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Overdose1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Post procedural bile leak0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Procedural pain1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Thermal burn1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Transfusion reaction1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Investigations
    Alanine aminotransferase increased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Aspartate aminotransferase increased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Bilirubin conjugated increased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Blood bilirubin increased1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Blood creatinine increased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Blood potassium decreased0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Haemoglobin decreased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Lipase increased1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Weight decreased0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Metabolism and nutrition disorders
    Decreased appetite4/321 (1.2%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Dehydration0/321 (0%) 0/316 (0%) 0/39 (0%) 3/125 (2.4%)
    Diabetes mellitus2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Fluid overload1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Hypoglycaemia3/321 (0.9%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Hypokalaemia1/321 (0.3%) 3/316 (0.9%) 1/39 (2.6%) 0/125 (0%)
    Hypomagnesaemia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Hyponatraemia0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Hypophosphataemia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Hypovolaemia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain3/321 (0.9%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Fibromyalgia0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Joint swelling1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Osteoarthritis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Osteoporosis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pain in extremity0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Tenosynovitis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma benign0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Bladder cancer0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Colon cancer1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Gastric cancer1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Gastrointestinal stromal tumour2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Hepatic neoplasm0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Hodgkin's disease0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Infected neoplasm1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Lip and/or oral cavity cancer1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Lung neoplasm malignant1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Metastases to liver0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Metastases to peritoneum0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Neoplasm0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Pancreatic carcinoma metastatic0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Small intestine carcinoma0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Thyroid cancer1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Tumour haemorrhage3/321 (0.9%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Tumour necrosis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Tumour pain0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Tumour perforation0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Urinary tract neoplasm0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Nervous system disorders
    Altered state of consciousness1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cerebral haemorrhage0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Cerebral infarction1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cerebral ischaemia1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cerebrovascular accident1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cognitive disorder1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Complex partial seizures1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Convulsion1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Dizziness0/321 (0%) 0/316 (0%) 2/39 (5.1%) 0/125 (0%)
    Epilepsy1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Haemorrhage intracranial0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Haemorrhagic stroke0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Headache1/321 (0.3%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Hemiparesis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    IIIrd nerve paralysis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Ischaemic stroke0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Loss of consciousness1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Migraine1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Myelitis transverse1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Peripheral motor neuropathy0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Peripheral sensory neuropathy0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Radiculopathy0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Sciatica2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Status epilepticus0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Syncope0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Psychiatric disorders
    Confusional state0/321 (0%) 2/316 (0.6%) 0/39 (0%) 0/125 (0%)
    Mental status changes0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Renal and urinary disorders
    Anuria0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Haematuria0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pollakiuria1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Renal failure0/321 (0%) 0/316 (0%) 1/39 (2.6%) 1/125 (0.8%)
    Renal failure acute1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Renal impairment0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Urinary tract obstruction0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Reproductive system and breast disorders
    Scrotal oedema0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Respiratory, thoracic and mediastinal disorders
    Atelectasis1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Chronic obstructive pulmonary disease2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Cough1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Dyspnoea2/321 (0.6%) 1/316 (0.3%) 1/39 (2.6%) 0/125 (0%)
    Interstitial lung disease0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Laryngeal oedema0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pleural effusion1/321 (0.3%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Pneumothorax1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Pulmonary embolism0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pulmonary fibrosis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pulmonary infarction1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Pulmonary oedema0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Respiratory failure2/321 (0.6%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Respiratory tract haemorrhage0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Upper respiratory tract congestion0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Erythema multiforme0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Exfoliative rash0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Pityriasis rosea0/321 (0%) 0/316 (0%) 0/39 (0%) 1/125 (0.8%)
    Rash0/321 (0%) 1/316 (0.3%) 1/39 (2.6%) 0/125 (0%)
    Rash generalised0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Surgical and medical procedures
    Cytoreductive surgery0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Gastrectomy0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Tumour excision0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Vascular disorders
    Deep vein thrombosis1/321 (0.3%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Femoral artery occlusion1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Hypotension1/321 (0.3%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Peripheral arterial occlusive disease2/321 (0.6%) 0/316 (0%) 0/39 (0%) 0/125 (0%)
    Thrombosis0/321 (0%) 0/316 (0%) 1/39 (2.6%) 0/125 (0%)
    Vena cava thrombosis0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Venous thrombosis limb0/321 (0%) 1/316 (0.3%) 0/39 (0%) 0/125 (0%)
    Other (Not Including Serious) Adverse Events
    NilotinibImatinibCrossover NilotinibCrossover Imatinib
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total291/321 (90.7%) 289/316 (91.5%) 28/39 (71.8%) 89/125 (71.2%)
    Blood and lymphatic system disorders
    Anaemia38/321 (11.8%) 61/316 (19.3%) 7/39 (17.9%) 20/125 (16%)
    Leukopenia4/321 (1.2%) 35/316 (11.1%) 1/39 (2.6%) 10/125 (8%)
    Neutropenia4/321 (1.2%) 42/316 (13.3%) 1/39 (2.6%) 11/125 (8.8%)
    Thrombocytopenia2/321 (0.6%) 5/316 (1.6%) 2/39 (5.1%) 1/125 (0.8%)
    Eye disorders
    Eyelid oedema5/321 (1.6%) 55/316 (17.4%) 0/39 (0%) 19/125 (15.2%)
    Lacrimation increased3/321 (0.9%) 21/316 (6.6%) 0/39 (0%) 3/125 (2.4%)
    Periorbital oedema2/321 (0.6%) 58/316 (18.4%) 0/39 (0%) 9/125 (7.2%)
    Gastrointestinal disorders
    Abdominal distension17/321 (5.3%) 12/316 (3.8%) 1/39 (2.6%) 1/125 (0.8%)
    Abdominal pain63/321 (19.6%) 61/316 (19.3%) 6/39 (15.4%) 18/125 (14.4%)
    Abdominal pain upper38/321 (11.8%) 15/316 (4.7%) 1/39 (2.6%) 5/125 (4%)
    Constipation49/321 (15.3%) 24/316 (7.6%) 3/39 (7.7%) 3/125 (2.4%)
    Diarrhoea46/321 (14.3%) 106/316 (33.5%) 2/39 (5.1%) 17/125 (13.6%)
    Nausea73/321 (22.7%) 105/316 (33.2%) 12/39 (30.8%) 20/125 (16%)
    Stomatitis10/321 (3.1%) 14/316 (4.4%) 2/39 (5.1%) 1/125 (0.8%)
    Vomiting51/321 (15.9%) 65/316 (20.6%) 5/39 (12.8%) 10/125 (8%)
    General disorders
    Asthenia27/321 (8.4%) 29/316 (9.2%) 0/39 (0%) 6/125 (4.8%)
    Face oedema5/321 (1.6%) 43/316 (13.6%) 0/39 (0%) 13/125 (10.4%)
    Fatigue66/321 (20.6%) 65/316 (20.6%) 7/39 (17.9%) 12/125 (9.6%)
    Oedema peripheral29/321 (9%) 68/316 (21.5%) 2/39 (5.1%) 17/125 (13.6%)
    Pyrexia23/321 (7.2%) 30/316 (9.5%) 3/39 (7.7%) 4/125 (3.2%)
    Hepatobiliary disorders
    Hyperbilirubinaemia63/321 (19.6%) 11/316 (3.5%) 3/39 (7.7%) 3/125 (2.4%)
    Infections and infestations
    Nasopharyngitis25/321 (7.8%) 19/316 (6%) 1/39 (2.6%) 1/125 (0.8%)
    Upper respiratory tract infection8/321 (2.5%) 17/316 (5.4%) 0/39 (0%) 1/125 (0.8%)
    Investigations
    Alanine aminotransferase increased45/321 (14%) 18/316 (5.7%) 5/39 (12.8%) 3/125 (2.4%)
    Amylase increased8/321 (2.5%) 13/316 (4.1%) 2/39 (5.1%) 2/125 (1.6%)
    Aspartate aminotransferase increased23/321 (7.2%) 15/316 (4.7%) 2/39 (5.1%) 2/125 (1.6%)
    Blood alkaline phosphatase increased7/321 (2.2%) 3/316 (0.9%) 3/39 (7.7%) 2/125 (1.6%)
    Blood bilirubin increased32/321 (10%) 4/316 (1.3%) 2/39 (5.1%) 1/125 (0.8%)
    Gamma-glutamyltransferase increased9/321 (2.8%) 2/316 (0.6%) 4/39 (10.3%) 1/125 (0.8%)
    Haemoglobin decreased10/321 (3.1%) 20/316 (6.3%) 3/39 (7.7%) 5/125 (4%)
    Lipase increased27/321 (8.4%) 23/316 (7.3%) 1/39 (2.6%) 6/125 (4.8%)
    Neutrophil count decreased2/321 (0.6%) 24/316 (7.6%) 1/39 (2.6%) 7/125 (5.6%)
    Weight decreased27/321 (8.4%) 20/316 (6.3%) 3/39 (7.7%) 3/125 (2.4%)
    White blood cell count decreased3/321 (0.9%) 21/316 (6.6%) 0/39 (0%) 11/125 (8.8%)
    Metabolism and nutrition disorders
    Decreased appetite40/321 (12.5%) 50/316 (15.8%) 5/39 (12.8%) 5/125 (4%)
    Hyperglycaemia15/321 (4.7%) 7/316 (2.2%) 2/39 (5.1%) 2/125 (1.6%)
    Hyperuricaemia2/321 (0.6%) 5/316 (1.6%) 2/39 (5.1%) 1/125 (0.8%)
    Hypokalaemia9/321 (2.8%) 19/316 (6%) 0/39 (0%) 8/125 (6.4%)
    Hypophosphataemia20/321 (6.2%) 53/316 (16.8%) 3/39 (7.7%) 10/125 (8%)
    Musculoskeletal and connective tissue disorders
    Arthralgia20/321 (6.2%) 15/316 (4.7%) 2/39 (5.1%) 3/125 (2.4%)
    Back pain32/321 (10%) 18/316 (5.7%) 3/39 (7.7%) 3/125 (2.4%)
    Muscle spasms18/321 (5.6%) 47/316 (14.9%) 1/39 (2.6%) 2/125 (1.6%)
    Myalgia39/321 (12.1%) 17/316 (5.4%) 2/39 (5.1%) 2/125 (1.6%)
    Pain in extremity22/321 (6.9%) 16/316 (5.1%) 2/39 (5.1%) 3/125 (2.4%)
    Nervous system disorders
    Dizziness22/321 (6.9%) 19/316 (6%) 2/39 (5.1%) 4/125 (3.2%)
    Dysgeusia10/321 (3.1%) 9/316 (2.8%) 2/39 (5.1%) 3/125 (2.4%)
    Headache54/321 (16.8%) 24/316 (7.6%) 5/39 (12.8%) 2/125 (1.6%)
    Psychiatric disorders
    Insomnia21/321 (6.5%) 20/316 (6.3%) 1/39 (2.6%) 2/125 (1.6%)
    Respiratory, thoracic and mediastinal disorders
    Cough28/321 (8.7%) 21/316 (6.6%) 1/39 (2.6%) 3/125 (2.4%)
    Dyspnoea17/321 (5.3%) 21/316 (6.6%) 2/39 (5.1%) 5/125 (4%)
    Skin and subcutaneous tissue disorders
    Alopecia33/321 (10.3%) 13/316 (4.1%) 1/39 (2.6%) 3/125 (2.4%)
    Dry skin19/321 (5.9%) 21/316 (6.6%) 0/39 (0%) 3/125 (2.4%)
    Pruritus39/321 (12.1%) 25/316 (7.9%) 4/39 (10.3%) 2/125 (1.6%)
    Rash89/321 (27.7%) 46/316 (14.6%) 4/39 (10.3%) 12/125 (9.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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 or disclosure of trial results in their entirety.

    Results Point of Contact

    Name/TitleStudy Director
    OrganizationNovartis Pharmaceuticals
    Phone862-778-8300
    Email
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00785785
    Other Study ID Numbers:
    • CAMN107G2301
    • 2008-004758-34
    First Posted:
    Nov 5, 2008
    Last Update Posted:
    Jun 16, 2016
    Last Verified:
    May 1, 2016