{"groups":[{"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","id":"FG000","title":"NTCS Phase"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"163"}],"comment":"Patients who should have satisfied all the inclusion and none of the exclusion criteria were to be enrolled into the consolidation phase where the patients were treated with nilotinib with the same dose as prior to study entry. Duration of the consolidation phase was 52 weeks or until a patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or treatment was discontinued at the discretion of the Investigator or due to withdrawal of consent.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"126"}],"comment":"The duration of the TFR phase was up to 528 weeks after the last patient entered the TFR phase. Patients stopped taking nilotinib on the day they entered TFR phase.","type":"TFR Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"61"}],"comment":"Nilotinib treatment re-initiation (NTRI) phase: If a patient had a confirmed loss of MR4 (two consecutive BCR-ABL1 \\>0.01% IS) or loss of MMR (BCR-ABL1 \\>0.1% IS) in the TFR phase, the patient restarted nilotinib treatment.","type":"NTRI Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"26"}],"comment":"Patients who were not eligible to enter into the TFR phase after completing the first 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).","type":"NTCT Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"7"}],"comment":"Patients who maintained MR4.5 during the NTCT phase (a total of 104 weeks of treatment) were eligible to cease nilotinib treatment and enter the TFR-2 phase. The duration of the TFR-2 phase was up to 528 weeks after the last patient entered the TFR phase.","type":"TFR-2 Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"2"}],"comment":"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 resume nilotinib treatment at a dose of either 300 mg or 400 mg b.i.d. The frequency of assessments for the NTRI-2 phase was similar to those of the NTRI phase.","type":"NTRI-2 Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"14"}],"comment":"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 treatment prolonged continuation phase (NTCT-P) and continued nilotinib treatment until 528 weeks after the last patient entered the TFR phase, or until the patients experience unacceptable toxicity, disease progression, death, lost to follow-up.","type":"NTCT-P Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"152"}],"comment":"Completed = Completed 52 weeks of NTCS phase","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Informed consent was obtained from each participant in writing before screening before any study specific procedure was performed.","recruitmentDetails":"Recruitment for the study comprised a total of 163 participants, who were enrolled at 63 clinical sites distributed across 18 different countries..\n\nArgentina (2), Australia (3), Belgium (1), Brazil (6), Canada (4), France (5), Germany (5), Greece (3), Israel (3), Japan (7), Mexico (1), Poland (3), Russia (3), Singapore (1), South Korea (1), Spain (8), UK (2), US (5)"}