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In order for patients to be eligible for the TFR phase, they had to fulfill the protocol specific definition of durable MRD.","id":"EG000","otherNumAffected":159,"otherNumAtRisk":215,"seriousNumAffected":20,"seriousNumAtRisk":215,"title":"NTCS"},{"deathsNumAffected":2,"deathsNumAtRisk":190,"description":"Nilotinib treatment-free remission (TFR) phase: Patients who fulfilled the protocol specific definition of durable MRD at the end of the NTCS phase were to suspend nilotinib therapy on the day they entered this phase.","id":"EG001","otherNumAffected":136,"otherNumAtRisk":190,"seriousNumAffected":34,"seriousNumAtRisk":190,"title":"TFR Phase"},{"deathsNumAffected":5,"deathsNumAtRisk":91,"description":"Nilotinib treatment re-initiation (NTRI) phase: If a patient had a loss of MMR (BCR::ABL1 \\> 0.1% IS) in the TFR phase, the patient restarted nilotinib treatment. Patients were on nilotinib treatment for up to 528 weeks after the last patient entered the nilotinib TFR phase.","id":"EG002","otherNumAffected":86,"otherNumAtRisk":91,"seriousNumAffected":40,"seriousNumAtRisk":91,"title":"NTRI"},{"deathsNumAffected":0,"deathsNumAtRisk":13,"description":"Nilotinib treatment continuation (NTCT) phase: If a patient was ineligible to start the TFR phase, he/she continued the nilotinib treatment in the continuation phase (52 weeks).","id":"EG003","otherNumAffected":11,"otherNumAtRisk":13,"seriousNumAffected":1,"seriousNumAtRisk":13,"title":"NTCT"},{"deathsNumAffected":0,"deathsNumAtRisk":10,"description":"Nilotinib treatment-free remission-2 (TFR-2) phase: Patients who fulfilled the protocol specific definition of durable MRD after the continuation phase (NTCT) were to suspend nilotinib therapy on the day they entered this phase. Duration of the TFR-2 phase and the BCR::ABL1 transcript level monitoring schedule was the same as that for the TFR phase. During the TFR-2 phase, the same rules in case of loss of MR4.0 or of MMR were applied as during the TFR phase.","id":"EG004","otherNumAffected":7,"otherNumAtRisk":10,"seriousNumAffected":1,"seriousNumAtRisk":10,"title":"TFR-2"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Nilotinib treatment re-initiation-2 (NTRI-2) phase: In the nilotinib TFR-2 phase, loss of MMR required nilotinib treatment re-initiation and patients were to enter NTRI-2 phase. The NTRI-2 phase was conducted in the same manner as the NTRI phase.","id":"EG005","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":3,"seriousNumAtRisk":5,"title":"NTRI-2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Nilotinib treatment prolonged continuation (NTCT - P) phase: Patients were eligible to enter the TFR-2 phase after the NTCT phase if they fulfilled the protocol-specific definition of durable MRD. Patients who did not qualify to start TFR-2 continued to receive nilotinib treatment in the NTCT-P phase for up to 528 weeks after the last patient entered the nilotinib TFR phase, or until the patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or the treatment was discontinued at the discretion of the Investigator or withdrawal of consent. The patients in the NTCT-P phase were followed for safety and efficacy (PCR data).","id":"EG006","otherNumAffected":2,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"NTCT-P"},{"deathsNumAffected":9,"deathsNumAtRisk":215,"description":"All the patients enrolled in the study","id":"EG007","otherNumAffected":205,"otherNumAtRisk":215,"seriousNumAffected":84,"seriousNumAtRisk":215,"title":"All Patients"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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