<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698905</url>
  </required_header>
  <id_info>
    <org_study_id>CAMN107A2408</org_study_id>
    <secondary_id>2012-003186-18</secondary_id>
    <nct_id>NCT01698905</nct_id>
  </id_info>
  <brief_title>Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)</brief_title>
  <acronym>ENESTop</acronym>
  <official_title>A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in&#xD;
      chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib&#xD;
      (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for&#xD;
      at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at&#xD;
      least 3 years and have very small amount of leukemia cells remaining after the nilotinib&#xD;
      (Tasigna) treatment will qualify for the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Primary objective was to evaluate the proportion of patients in TFR within 48 weeks&#xD;
      following nilotinib cessation.&#xD;
&#xD;
      This study originally consisted of seven phases (five treatment phases and two treatment-free&#xD;
      phases) from which two were the focus of this primary analysis report (consolidation, TFR and&#xD;
      treatment re-initiation) The study consisted of 2 main phases: Consolidation and TFR&#xD;
&#xD;
      Nilotinib treatment consolidation phase (NTCS): Patients who satisfied all&#xD;
      inclusion/exclusion criteria were enrolled in the consolidation phase and continued to&#xD;
      receive nilotinib for 52 weeks at the dose which the patient was receiving prior to study&#xD;
      entry. If a patient maintained MR4.5 throughout the consolidation phase, he/she was eligible&#xD;
      to enter in the TFR phase. If a patient had confirmed loss of MR4.5 during the consolidation&#xD;
      phase, he/she was not eligible to enter in the TFR phase and continued nilotinib treatment.&#xD;
&#xD;
      Nilotinib TFR phase: Patients who were eligible to enter in the TFR phase after completing&#xD;
      the 52 week consolidation phase stopped taking nilotinib on the first day of the TFR phase.&#xD;
      Duration of this phase was up to 520 weeks after the last patient enters in the TFR phase.&#xD;
&#xD;
      Nilotinib treatment re-initiation phase (NTRI): If a patient had a confirmed loss of MR4 (two&#xD;
      consecutive BCR-ABL &gt;0.01% IS) or loss of MMR (BCR-ABL &gt;0.1% IS) in the TFR phase, the&#xD;
      patient restarted nilotinib treatment. Patients will be on nilotinib treatment for up to 520&#xD;
      weeks after the last patient entered the nilotinib TFR phase, or until a patient experience&#xD;
      unacceptable toxicity, disease progression and/or treatment discontinued at the discretion of&#xD;
      the Investigator or if the patient withdrew consent. Nilotinib cessation was not attempted&#xD;
      for a second time in the patient who reinitiated treatment or discontinued following the TFR&#xD;
      phase.&#xD;
&#xD;
      Nilotinib treatment continuation phase (NTCT) and Nilotinib treatment prolonged continuation&#xD;
      phase (NTCT-P): Patients who were not eligible to enter into the TFR phase after completing&#xD;
      the 52-week NTCS phase entered the nilotinib treatment continuation (NTCT) phase and would&#xD;
      continue treatment with nilotinib for another 52 weeks (a total of 104 weeks of treatment).&#xD;
      Patients who were not able to maintain MR4.5 and had a confirmed loss of MR4.5 during the&#xD;
      NTCT phase were not eligible to enter the TFR-2 phase. These patients entered into the&#xD;
      nilotinib prolonged treatment continuation phase (NTCT-P) and continued nilotinib treatment&#xD;
      until 520 weeks after the last patient entered the nilotinib TFR phase, or until the patients&#xD;
      experience unacceptable toxicity, disease progression and/or treatment would be discontinued&#xD;
      at the discretion of the Investigator or withdrawal of consent.&#xD;
&#xD;
      Nilotinib TFR-2 phase: Patients who maintained MR4.5 during the NTCT phase were eligible to&#xD;
      cease nilotinib treatment and enter the TFR-2 phase. The duration of the nilotinib TFR-2&#xD;
      phase is up to 520 weeks after the last patient entered the TFR phase. Patients stopped&#xD;
      taking nilotinib therapy on the day they entered the TFR-2 phase.&#xD;
&#xD;
      Nilotinib treatment re-initiation-2 (NTRI-2): If a patient had a loss of MMR or a confirmed&#xD;
      loss of MR4 during the TFR-2 phase, he/she entered the nilotinib treatment re-initiation-2&#xD;
      (NTRI-2) phase and resumed nilotinib treatment at a dose of either 300 mg or 400 mg bid.&#xD;
&#xD;
      Safety follow-up was performed within 30 days after the last dose of study treatment or the&#xD;
      last day in TFR/TFR-2.&#xD;
&#xD;
      Post-treatment follow-up visits were performed every 12 weeks up to 520 weeks after the last&#xD;
      patient entered the nilotinib TFR phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 20, 2012</start_date>
  <completion_date type="Anticipated">February 6, 2025</completion_date>
  <primary_completion_date type="Actual">November 26, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks</measure>
    <time_frame>First 48 weeks following nilotinib cessation.</time_frame>
    <description>TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL &gt; 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients in Treatment Free Remission (TFR) Within 96, 144, 192, 264 Weeks and Within 6,7,8,9 and 10 Years</measure>
    <time_frame>96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation</time_frame>
    <description>TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL &gt; 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) to Accelerated Phase/Blast Crisis (AP/BC) or Death</measure>
    <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
    <description>Kaplan-Meier (KM) estimation of PFS. PFS is measured from the date of start of nilotinib TFR phase (cessation of nilotinib) to the date of the earliest of the event: progression to AP/BC, or death from any cause. Patients not known to have recurred or died on or before the cut-off date for the KM analysis will have their PFS interval right-censored at the earlier of the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Free Survival (TFS)</measure>
    <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
    <description>Kaplan-Meier (KM) estimation of TFS is measured from the date of the start of the nilotinib TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4, re-start of nilotinib treatment, progression to AP/BC or death from any cause. Patients not known to have had any of the events or died on or before the cut-off date for the KM analysis will have their TFS interval right-censored at the earlier of the date of their last assessment (PCR, cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up. A TFS sensitivity analysis will be conducted by considering discontinuation from TFR phase due to any reason as an event, in addition to the events as defined above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
    <description>Kaplan-Meier (KM) estimation of OS. OS is measured from the date of start of nilotinib TFR phase to the date of death from any cause. If a patient is not known to have died, survival will be censored at the date of last contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BCR-ABL (Oncoprotein Product of BCR-ABL Fusion Gene) Transcripts After Re-start of Nilotinib Therapy</measure>
    <time_frame>re-start of nilotinib up to approximately 48 weeks</time_frame>
    <description>Descriptive statistics of BCR-ABL over time after re-start of nilotinib therapy. ABL= Abelson leukemia virus and BCR=Break point cluster region</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Stable MMR in Nilotinib Re-initiation Phase</measure>
    <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
    <description>Percentage of patients who are in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MMR any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MMR, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR at any time during the nilotinib re-initiation phase, and multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Stable MR4 in Nilotinib Re-initiation Phase</measure>
    <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
    <description>Percentage of patients who are in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4, irrespective of whether there is loss of MR4 in between, by the number of patients who achieved MR4 at any time during the nilotinib re-initiation phase, and multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Stable MR4.5 in Nilotinib Re-initiation Phase</measure>
    <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
    <description>Percentage of patients who are in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4.5 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4.5, irrespective of whether there is loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the nilotinib re-initiation phase, multiplied by 100.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Chronic Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Nilotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nilotinib</intervention_name>
    <description>Nilotinib was dosed by weight or body surface area.&#xD;
Nilotinib 300 mg BID or 400 mg BID was be administered orally at approximately 12 hour intervals, and must not have been taken with food. The capsules were to be swallowed whole with water.&#xD;
No food should have been consumed for at least 2 hours before the dose was taken and no additional food should have been consumed for at least one hour after the dose was taken. Patients were also allowed to enter this study on the same dose they were taking prior to study entry. Patients who required permanent dose reduction from their original starting dose were to be allowed to enter this study on the same dose only if the patient maintained this dose for a minimum of 6 months prior to study entry.</description>
    <arm_group_label>Nilotinib</arm_group_label>
    <other_name>AMN107</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients &gt;= 18 years of age&#xD;
&#xD;
          2. ECOG Performance Status of 0, 1, or 2&#xD;
&#xD;
          3. Patient with diagnosis of BCR-ABL positive CML CP&#xD;
&#xD;
          4. Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment&#xD;
             (first with imatinib (&gt; 4 weeks) and then switched to nilotinib) since initial&#xD;
             diagnosis&#xD;
&#xD;
          5. Patient has at least 2 years of nilotinib treatment prior to study entry.&#xD;
&#xD;
          6. Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment,&#xD;
             and determined by a Novartis designated central PCR lab assessment at screening&#xD;
&#xD;
          7. Adequate end organ function as defined by:&#xD;
&#xD;
               -  Direct bilirubin ≤ 1.5 x ULN except for i) patient with documented Gilbert's&#xD;
                  syndrome for whom any bilirubin value is allowed and ii) for patients with&#xD;
                  asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase&#xD;
                  within normal range)&#xD;
&#xD;
               -  SGOT(AST) and SGPT(ALT) &lt; 3 x ULN (upper limit of normal)&#xD;
&#xD;
               -  Serum lipase ≤ 2 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN&#xD;
&#xD;
               -  Serum creatinine &lt; 1.5 x ULN&#xD;
&#xD;
          8. Patients must have the following electrolyte values ≥ LLN (lower limit of normal)&#xD;
             limits or corrected to within normal limits with supplements prior to the first dose&#xD;
             of study medication:&#xD;
&#xD;
               -  Potassium&#xD;
&#xD;
               -  Magnesium&#xD;
&#xD;
               -  Total calcium (corrected for serum albumin)&#xD;
&#xD;
          9. Patients must have normal marrow function as defined below:&#xD;
&#xD;
               -  Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L&#xD;
&#xD;
               -  Platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
         10. Written informed consent obtained prior to any screening procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior AP, BC or allo-transplant&#xD;
&#xD;
          2. Patient has documented MR4.5 at the time when switched from imatinib to nilotinib&#xD;
&#xD;
          3. Patients with known atypical transcript&#xD;
&#xD;
          4. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a&#xD;
             testing was done in the past (there is no requirement to perform mutation testing at&#xD;
             study entry if it was not done in the past)&#xD;
&#xD;
          5. Dose reductions due to neutropenia or thrombocytopenia in the past 6 months&#xD;
&#xD;
          6. Patient ever attempted to permanently discontinue imatinib or nilotinib treatment&#xD;
&#xD;
          7. Known impaired cardiac function including any one of the following:&#xD;
&#xD;
               -  Inability to determine the QT interval on ECG&#xD;
&#xD;
               -  Complete left bundle branch block&#xD;
&#xD;
               -  Long QT syndrome or a known family history of long QT syndrome&#xD;
&#xD;
               -  History of or presence of clinically significant ventricular or atrial&#xD;
                  tachyarrhythmias&#xD;
&#xD;
               -  Clinically significant resting bradycardia&#xD;
&#xD;
               -  QTcF &gt; 480 msec&#xD;
&#xD;
               -  History or clinical signs of myocardial infarction within 1 year prior to study&#xD;
                  entry&#xD;
&#xD;
               -  History of unstable angina within 1 year prior to study entry&#xD;
&#xD;
               -  Other clinically significant heart disease (e.g. uncontrolled congestive heart&#xD;
                  failure or uncontrolled hypertension)&#xD;
&#xD;
          8. Severe and/or uncontrolled concurrent medical disease that in the opinion of the&#xD;
             investigator could cause unacceptable safety risks or compromise compliance with the&#xD;
             protocol (e.g. uncontrolled diabetes (defined as HbA1c &gt; 9%), uncontrolled infection)&#xD;
&#xD;
          9. History of acute pancreatitis within 1 year prior to study entry or past medical&#xD;
             history of chronic pancreatitis&#xD;
&#xD;
         10. Known presence of a significant congenital or acquired bleeding disorder unrelated to&#xD;
             cancer&#xD;
&#xD;
         11. History of other active malignancy within 5 years prior to study entry with the&#xD;
             exception of previous or concomitant basal cell skin cancer, previous cervical&#xD;
             carcinoma in situ treated curatively&#xD;
&#xD;
         12. Patients who have not recovered from prior surgery&#xD;
&#xD;
         13. Treatment with other investigational agents (defined as not used in accordance with&#xD;
             the approved indication) within 4 weeks of Day 1&#xD;
&#xD;
         14. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and&#xD;
             the treatment cannot be either discontinued or switched to a different medication&#xD;
             prior to study entry. See Appendix 14.1 for a list of these medications. This list may&#xD;
             not be comprehensive.&#xD;
&#xD;
         15. Patients actively receiving therapy with herbal medicines that are strong CYP3A4&#xD;
             inhibitors and/or inducers, and the treatment cannot be either discontinued or&#xD;
             switched to a different medication prior to study entry. These herbal medicines may&#xD;
             include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine,&#xD;
             Artemisinin, St. John's Wort, and Ginkgo.&#xD;
&#xD;
         16. Patients who are currently receiving treatment with any medications that have the&#xD;
             potential to prolong the QT interval and the treatment cannot be either safely&#xD;
             discontinued or switched to a different medication prior to study entry. (Please see&#xD;
             www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm for a list of agents&#xD;
             that prolong the QT interval.)&#xD;
&#xD;
         17. Impairment of gastrointestinal (GI) function or GI disease that may significantly&#xD;
             alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea,&#xD;
             vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass&#xD;
             surgery)&#xD;
&#xD;
         18. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive hCG laboratory test.&#xD;
&#xD;
         19. Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, must have a negative serum pregnancy test before initiation of&#xD;
             study treatment and must also use highly effective methods of contraception while&#xD;
             enrolled in the study. The use of highly effective contraception should continue for&#xD;
             at least 14 days after the last dose of study treatment or until the last day of&#xD;
             TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is&#xD;
             longer. Acceptable forms of highly effective contraception methods include:&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
                  contraception&#xD;
&#xD;
               -  Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks before&#xD;
                  taking study treatment. In case of oophorectomy alone, only when the reproductive&#xD;
                  status of the woman has been confirmed by follow up hormone level assessment&#xD;
&#xD;
               -  Male sterilization (at least 6 months prior to screening). The vasectomized male&#xD;
                  partner should be the sole partner for that subject Use of oral, injected or&#xD;
                  implanted hormonal methods of contraception or placement of an intrauterine&#xD;
                  device (IUD) or intrauterine system (IUS), or other forms of hormonal&#xD;
                  contraception that have comparable efficacy (failure rate &lt;1%), for example&#xD;
                  hormone vaginal ring or transdermal hormone contraception. In case of use of oral&#xD;
                  contraception, women should be stable on the same pill for a minimum of 3 months&#xD;
                  before taking study treatment. Women are considered post-menopausal and not of&#xD;
                  child bearing potential if they have had 12 months of natural (spontaneous)&#xD;
                  amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of&#xD;
                  vasomotor symptoms) or have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to&#xD;
                  enrolling. In the case of oophorectomy alone, only when the reproductive status&#xD;
                  of the woman has been confirmed by follow up hormone level assessment is she&#xD;
                  considered not of child bearing potential. If a study patient becomes pregnant or&#xD;
                  is suspected of being pregnant during the study or within 30 days as part of&#xD;
                  safety evaluations after the final dose of nilotinib, the Study Doctor needs to&#xD;
                  be informed immediately and any ongoing study treatment with nilotinib has to be&#xD;
                  stopped immediately.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Kenneth Norris Comprehensive Cancer Center USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Blood and Marrow Institute SC</name>
      <address>
        <city>Beech Grove</city>
        <state>Indiana</state>
        <zip>46107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Agnes Hospital SC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch SC</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-1188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Oncology</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98683</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1221ADC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1114AAN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
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      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <zip>74605-050</zip>
        <country>Brazil</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20.211-030</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rio De Janiero</city>
        <state>RJ</state>
        <zip>20231-050</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13083-970</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Strasbourg cedex</city>
        <zip>67085</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68305</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heilbronn</city>
        <zip>74072</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Larissa</city>
        <state>GR</state>
        <zip>411 10</zip>
        <country>Greece</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>106 76</zip>
        <country>Greece</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>18547</zip>
        <country>Greece</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
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        <zip>3109601</zip>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464 8681</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Narita</city>
        <state>Chiba</state>
        <zip>286-8523</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fukuoka city</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kurume city</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Akita</city>
        <zip>010-8543</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aomori</city>
        <zip>030 8553</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chiba</city>
        <zip>260 8677</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Seocho Gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64718</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>30-510</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02 776</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>125167</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41013</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Badalona</city>
        <state>Catalunya</state>
        <zip>08916</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Alicante</city>
        <state>Comunidad Valenciana</state>
        <zip>03010</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Laguna</city>
        <state>Santa Cruz De Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
    <country>Tunisia</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>December 17, 2020</results_first_submitted>
  <results_first_submitted_qc>December 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2021</results_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AMN107</keyword>
  <keyword>CML</keyword>
  <keyword>Phase II</keyword>
  <keyword>single arm</keyword>
  <keyword>open label</keyword>
  <keyword>nilotinib</keyword>
  <keyword>treatment-free remission</keyword>
  <keyword>MR4.5</keyword>
  <keyword>confirmed loss of MR4</keyword>
  <keyword>loss of MMR</keyword>
  <keyword>Ph+ CML-CP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 163 patients were enrolled into this study. 126 of the 163 patients who completed 52 weeks of nilotinib treatment in the NTCS phase entered the TFR phase and were part of the Full analysis Set (FAS).</recruitment_details>
      <pre_assignment_details>Approximately 117 patients were planned to be enrolled into this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>NTCS Phase</title>
          <description>Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Still on Study Phase</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>TFR Phase</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NTRI Phase</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NTCT Phase</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>TFR-2 Phase</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NTRI-2 Phase</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NTCT-P Phase Phase</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/guardian decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set: The safety set included all patients who received at least one dose of study medication in the Consolidation Phase.</population>
      <group_list>
        <group group_id="B1">
          <title>NTCS Phase</title>
          <description>Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="163"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.3" spread="13.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks</title>
        <description>TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL &gt; 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.</description>
        <time_frame>First 48 weeks following nilotinib cessation.</time_frame>
        <population>Full Analysis Set (FAS): FAS included all patients who entered the TFR phase.</population>
        <group_list>
          <group group_id="O1">
            <title>NTCS Phase</title>
            <description>Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks</title>
          <description>TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL &gt; 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.</description>
          <population>Full Analysis Set (FAS): FAS included all patients who entered the TFR phase.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9" lower_limit="48.8" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients in Treatment Free Remission (TFR) Within 96, 144, 192, 264 Weeks and Within 6,7,8,9 and 10 Years</title>
        <description>TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL &gt; 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, multiplied by 100.</description>
        <time_frame>96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) to Accelerated Phase/Blast Crisis (AP/BC) or Death</title>
        <description>Kaplan-Meier (KM) estimation of PFS. PFS is measured from the date of start of nilotinib TFR phase (cessation of nilotinib) to the date of the earliest of the event: progression to AP/BC, or death from any cause. Patients not known to have recurred or died on or before the cut-off date for the KM analysis will have their PFS interval right-censored at the earlier of the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up.</description>
        <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Free Survival (TFS)</title>
        <description>Kaplan-Meier (KM) estimation of TFS is measured from the date of the start of the nilotinib TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4, re-start of nilotinib treatment, progression to AP/BC or death from any cause. Patients not known to have had any of the events or died on or before the cut-off date for the KM analysis will have their TFS interval right-censored at the earlier of the date of their last assessment (PCR, cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up. A TFS sensitivity analysis will be conducted by considering discontinuation from TFR phase due to any reason as an event, in addition to the events as defined above</description>
        <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Kaplan-Meier (KM) estimation of OS. OS is measured from the date of start of nilotinib TFR phase to the date of death from any cause. If a patient is not known to have died, survival will be censored at the date of last contact.</description>
        <time_frame>nilotinib cessation up to approximately 580 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in BCR-ABL (Oncoprotein Product of BCR-ABL Fusion Gene) Transcripts After Re-start of Nilotinib Therapy</title>
        <description>Descriptive statistics of BCR-ABL over time after re-start of nilotinib therapy. ABL= Abelson leukemia virus and BCR=Break point cluster region</description>
        <time_frame>re-start of nilotinib up to approximately 48 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Stable MMR in Nilotinib Re-initiation Phase</title>
        <description>Percentage of patients who are in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MMR any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MMR, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR at any time during the nilotinib re-initiation phase, and multiplied by 100.</description>
        <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Stable MR4 in Nilotinib Re-initiation Phase</title>
        <description>Percentage of patients who are in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4, irrespective of whether there is loss of MR4 in between, by the number of patients who achieved MR4 at any time during the nilotinib re-initiation phase, and multiplied by 100.</description>
        <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Stable MR4.5 in Nilotinib Re-initiation Phase</title>
        <description>Percentage of patients who are in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4.5 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4.5, irrespective of whether there is loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the nilotinib re-initiation phase, multiplied by 100.</description>
        <time_frame>start of nilotinib in re-initiation phase up to approximately 432 weeks</time_frame>
        <posting_date>02/2026</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.</time_frame>
      <desc>Any sign or symptom that occurs during the study treatment plus 30 days post treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>NTCS Phase</title>
          <description>Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening</description>
        </group>
        <group group_id="E2">
          <title>TFR Phase</title>
          <description>treatment-free remission</description>
        </group>
        <group group_id="E3">
          <title>NTRI Phase</title>
          <description>nilotinib treatment re-initiation</description>
        </group>
        <group group_id="E4">
          <title>NTCT Phase</title>
          <description>nilotinib treatment continuation</description>
        </group>
        <group group_id="E5">
          <title>TFR-2 Phase</title>
          <description>treatment-free remission 2</description>
        </group>
        <group group_id="E6">
          <title>NTRI-2 Phase</title>
          <description>nilotinib treatment re-initiation 2</description>
        </group>
        <group group_id="E7">
          <title>NTCT-P Phase</title>
          <description>nilotinib treatment prolonged continuation</description>
        </group>
        <group group_id="E8">
          <title>All Patients</title>
          <description>All patients enrolled in the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="34" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>NECROSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>LIGAMENT SPRAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HAEMATOLOGY TEST ABNORMAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>TRANSAMINASES INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>TYPE 2 DIABETES MELLITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>LUNG ADENOCARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>LYMPHOPROLIFERATIVE DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>URETERIC CANCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CARPAL TUNNEL SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>CEREBRAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>METRORRHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PLEURAL FIBROSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ARTERIAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="122" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN LOWER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>WEIGHT INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>HYPERTRIGLYCERIDAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="43" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="15" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="22" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI 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 pooled data (i.e.,data from all sites) in clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis</organization>
      <phone>862-778-8300</phone>
      <email>novartis.email@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698905
org study id: CAMN107A2408
secondary id: 2012-003186-18
nct id: NCT01698905
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in
      chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib
      (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for
      at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at
      least 3 years and have very small amount of leukemia cells remaining after the nilotinib
      (Tasigna) treatment will qualify for the study.
The Primary objective was to evaluate the proportion of patients in TFR within 48 weeks
      following nilotinib cessation.

      This study originally consisted of seven phases (five treatment phases and two treatment-free
      phases) from which two were the focus of this primary analysis report (consolidation, TFR and
      treatment re-initiation) The study consisted of 2 main phases: Consolidation and TFR

      Nilotinib treatment consolidation phase (NTCS): Patients who satisfied all
      inclusion/exclusion criteria were enrolled in the consolidation phase and continued to
      receive nilotinib for 52 weeks at the dose which the patient was receiving prior to study
      entry. If a patient maintained MR4.5 throughout the consolidation phase, he/she was eligible
      to enter in the TFR phase. If a patient had confirmed loss of MR4.5 during the consolidation
      phase, he/she was not eligible to enter in the TFR phase and continued nilotinib treatment.

      Nilotinib TFR phase: Patients who were eligible to enter in the TFR phase after completing
      the 52 week consolidation phase stopped taking nilotinib on the first day of the TFR phase.
      Duration of this phase was up to 520 weeks after the last patient enters in the TFR phase.

      Nilotinib treatment re-initiation phase (NTRI): If a patient had a confirmed loss of MR4 (two
      consecutive BCR-ABL >0.01% IS) or loss of MMR (BCR-ABL >0.1% IS) in the TFR phase, the
      patient restarted nilotinib treatment. Patients will be on nilotinib treatment for up to 520
      weeks after the last patient entered the nilotinib TFR phase, or until a patient experience
      unacceptable toxicity, disease progression and/or treatment discontinued at the discretion of
      the Investigator or if the patient withdrew consent. Nilotinib cessation was not attempted
      for a second time in the patient who reinitiated treatment or discontinued following the TFR
      phase.

      Nilotinib treatment continuation phase (NTCT) and Nilotinib treatment prolonged continuation
      phase (NTCT-P): Patients who were not eligible to enter into the TFR phase after completing
      the 52-week NTCS phase entered the nilotinib treatment continuation (NTCT) phase and would
      continue treatment with nilotinib for another 52 weeks (a total of 104 weeks of treatment).
      Patients who were not able to maintain MR4.5 and had a confirmed loss of MR4.5 during the
      NTCT phase were not eligible to enter the TFR-2 phase. These patients entered into the
      nilotinib prolonged treatment continuation phase (NTCT-P) and continued nilotinib treatment
      until 520 weeks after the last patient entered the nilotinib TFR phase, or until the patients
      experience unacceptable toxicity, disease progression and/or treatment would be discontinued
      at the discretion of the Investigator or withdrawal of consent.

      Nilotinib TFR-2 phase: Patients who maintained MR4.5 during the NTCT phase were eligible to
      cease nilotinib treatment and enter the TFR-2 phase. The duration of the nilotinib TFR-2
      phase is up to 520 weeks after the last patient entered the TFR phase. Patients stopped
      taking nilotinib therapy on the day they entered the TFR-2 phase.

      Nilotinib treatment re-initiation-2 (NTRI-2): If a patient had a loss of MMR or a confirmed
      loss of MR4 during the TFR-2 phase, he/she entered the nilotinib treatment re-initiation-2
      (NTRI-2) phase and resumed nilotinib treatment at a dose of either 300 mg or 400 mg bid.

      Safety follow-up was performed within 30 days after the last dose of study treatment or the
      last day in TFR/TFR-2.

      Post-treatment follow-up visits were performed every 12 weeks up to 520 weeks after the last
      patient entered the nilotinib TFR phase.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks
time frame: First 48 weeks following nilotinib cessation.
description: TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL > 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.
measure: Percentage of Patients in Treatment Free Remission (TFR) Within 96, 144, 192, 264 Weeks and Within 6,7,8,9 and 10 Years
time frame: 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation
description: TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL > 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, multiplied by 100.
measure: Progression Free Survival (PFS) to Accelerated Phase/Blast Crisis (AP/BC) or Death
time frame: nilotinib cessation up to approximately 580 weeks
description: Kaplan-Meier (KM) estimation of PFS. PFS is measured from the date of start of nilotinib TFR phase (cessation of nilotinib) to the date of the earliest of the event: progression to AP/BC, or death from any cause. Patients not known to have recurred or died on or before the cut-off date for the KM analysis will have their PFS interval right-censored at the earlier of the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up.
measure: Treatment Free Survival (TFS)
time frame: nilotinib cessation up to approximately 580 weeks
description: Kaplan-Meier (KM) estimation of TFS is measured from the date of the start of the nilotinib TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4, re-start of nilotinib treatment, progression to AP/BC or death from any cause. Patients not known to have had any of the events or died on or before the cut-off date for the KM analysis will have their TFS interval right-censored at the earlier of the date of their last assessment (PCR, cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up. A TFS sensitivity analysis will be conducted by considering discontinuation from TFR phase due to any reason as an event, in addition to the events as defined above
measure: Overall Survival (OS)
time frame: nilotinib cessation up to approximately 580 weeks
description: Kaplan-Meier (KM) estimation of OS. OS is measured from the date of start of nilotinib TFR phase to the date of death from any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
measure: Change in BCR-ABL (Oncoprotein Product of BCR-ABL Fusion Gene) Transcripts After Re-start of Nilotinib Therapy
time frame: re-start of nilotinib up to approximately 48 weeks
description: Descriptive statistics of BCR-ABL over time after re-start of nilotinib therapy. ABL= Abelson leukemia virus and BCR=Break point cluster region
measure: Percentage of Patients With Stable MMR in Nilotinib Re-initiation Phase
time frame: start of nilotinib in re-initiation phase up to approximately 432 weeks
description: Percentage of patients who are in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MMR any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MMR, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR at any time during the nilotinib re-initiation phase, and multiplied by 100.
measure: Percentage of Patients With Stable MR4 in Nilotinib Re-initiation Phase
time frame: start of nilotinib in re-initiation phase up to approximately 432 weeks
description: Percentage of patients who are in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4, irrespective of whether there is loss of MR4 in between, by the number of patients who achieved MR4 at any time during the nilotinib re-initiation phase, and multiplied by 100.
measure: Percentage of Patients With Stable MR4.5 in Nilotinib Re-initiation Phase
time frame: start of nilotinib in re-initiation phase up to approximately 432 weeks
description: Percentage of patients who are in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4.5 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4.5, irrespective of whether there is loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the nilotinib re-initiation phase, multiplied by 100.
arm group label: Nilotinib
arm group type: Experimental
description: Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
intervention type: Drug
intervention name: nilotinib
description: Nilotinib was dosed by weight or body surface area.
Nilotinib 300 mg BID or 400 mg BID was be administered orally at approximately 12 hour intervals, and must not have been taken with food. The capsules were to be swallowed whole with water.
No food should have been consumed for at least 2 hours before the dose was taken and no additional food should have been consumed for at least one hour after the dose was taken. Patients were also allowed to enter this study on the same dose they were taking prior to study entry. Patients who required permanent dose reduction from their original starting dose were to be allowed to enter this study on the same dose only if the patient maintained this dose for a minimum of 6 months prior to study entry.
arm group label: Nilotinib
other name: AMN107
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Canada
country: France
country: Germany
country: Greece
country: Israel
country: Japan
country: Korea, Republic of
country: Mexico
country: Poland
country: Russian Federation
country: Singapore
country: Spain
country: United Kingdom
country: United States
country: Netherlands
country: Tunisia
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
participant flow: 
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reported events: 
certain agreements: 
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