Frequency of AEs/treatment-related AEs summarized by patient characteristic factor will be collected

Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected

AEs leading to interruption/discontinuation in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected

Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line will be collected

Factors affecting occurrence of AEs by treatment line will be collected

AEs leading to interruption/discontinuation by treatment line will be collected

Major molecular response is defined as BCR-ABL1 International Scale value ≤ 0.1%.

BCR-ABL1: translocation-produced fusion gene

Major molecular response (MMR) is defined as BCR-ABL1 International Scale value ≤ 0.1%.

BCR-ABL1: translocation-produced fusion gene

MR4.0 and MR4.5 rates are defined as :

• MR4.0: BCR-ABL1 International Scale value ≤ 0.01%
• MR4.5: BCR-ABL1 International Scale value ≤ 0.0032%

BCR-ABL1: translocation-produced fusion gene

This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.

This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

1. White blood cell count < 10,000/µL
2. Platelet count < 450,000/µL
3. No blast cell and promyelocyte in peripheral blood
4. Myelocyte + metamyelocyte in peripheral blood = 0%
5. Basophil < 5%
6. No spleen and liver swelling, and no extramedullary lesion

This study will collect the rate of patients with BCR-ABL1 gene mutations

This study will collect major molecular response (MMR) rates by Week 48 in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women)

This study will collect major molecular response (MMR) rates by treatment line

MR4.0 and MR4.5 rates are defined as :

• MR4.0: BCR-ABL1 International Scale value ≤ 0.01%
• MR4.5: BCR-ABL1 International Scale value ≤ 0.0032%

BCR-ABL1: translocation-produced fusion gene

This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.

This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

1. White blood cell count < 10,000/µL
2. Platelet count < 450,000/µL
3. No blast cell and promyelocyte in peripheral blood
4. Myelocyte + metamyelocyte in peripheral blood = 0%
5. Basophil < 5%
6. No spleen and liver swelling, and no extramedullary lesion