Adverse events

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.

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.

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.

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).

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.

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

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.

Participants who received study treatment and were monitored for adverse events during the on-treatment phase of the study. Post-treatment follow-up adverse events were not included in this group.

Participants who entered the post-treatment follow-up period after discontinuation of study treatment. During this phase, only deaths were collected: other adverse events were not collected.