MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method

Estimated median time to first MMR by Kaplan-Meier method

Full analysis set

Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375

Full Analysis set, Number of events / censored 29/312.

Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.

* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.

Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375

OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.

PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.

FAS

Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.

FAS