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. 2015 Jul 21;29(9):1832–1838. doi: 10.1038/leu.2015.168

Table 1. Triggers for mutational analysis: DASISION 3-year database.

On-treatment, clinically relevant events Off-treatment, reason for discontinuation from study
No confirmed CCyR within 12 months Disease progressiona
No MMR within 12 months Maximum clinical benefitb
Fivefold increase in BCR-ABL1 transcript Intolerance Treatment failure
levels with loss of MMR  
Loss of CCyRc Adverse event unrelated to study drug
  Withdrew consent
  Pregnancy
  Loss to follow-up
  Poor/noncompliance
  Subject request to discontinue

Abbreviations: CCyR, complete cytogenetic response; DASISION, Dasatinib versus Imatinib Study in Treatment-Naive CML-CP; MMR, major molecular response.

a

Increasing white blood cell count, loss of complete hematologic response (CHR), loss of major cytogenetic response, transformation to accelerated phase/blast phase and death.

b

Any subject who received study therapy and then discontinued treatment for intolerance (recurrent ≥grade 3 hematologic toxicity or ≥grade 2 nonhematologic toxicity despite dose reduction necessitating discontinuation of therapy) or treatment failure (lack of hematologic response at 3 months, lack of CHR or CyR at 6 months, lack of partial cytogenetic response at 12 months and lack of CCyR at 18 months).

c

As of last patient status; patients with interim loss of CCyR who subsequently regained a CCyR were not included.