Figure 1.
Study design and patient disposition.aRepresents that the study design includes a third cohort to recruit patients with CML-AP R/I to imatinib or dasatinib. No patients were enrolled in this cohort. bDenotes that nilotinib was administered at a dose of 230 mg/m2 twice daily (rounded to the nearest 50 mg, to a maximum dose of 400 mg) based on the recommended dose for adults of 400 mg twice daily, scaled to body surface area. At any time, discontinuation was allowed based on patient/investigator decision or because of unacceptable toxicities, disease progression, protocol deviations resulting in a significant risk to the patient’s safety, use of prohibited treatments, or pregnancy. Patients who discontinued the treatment early were contacted for study evaluation completion and survival status. cDenotes that 1 enrolled patient did not receive any study medication. dIndicates that administrative problems were 4 cases of “lack of efficacy” (2 in each cohort), 1 case of “lack of study compliance by patient” (R/I imatinib/dasatinib Ph+ CML-CP cohort), and 2 cases of “new cancer therapy” (1 in each cohort; the CRF does not have separate reasons for discontinuation for such cases, the information was thus voluntarily stored under the category “administrative problem”). eIndicates that protocol deviations were 2 cases of noncompliance. CRF, case report form.