Details of cytotoxic drugs and nilotinib during chemotherapy
| . | Induction (n = 90) . | Con #1 (n = 80) . | Con #2 (n = 65) . | Con #3 (n = 25) . | Con #4 (n = 8) . | Con #5 (n = 7) . |
|---|---|---|---|---|---|---|
| Cytotoxic drugs | ||||||
| Subjects with episode(s),* n (%) | 5 (6) | 15 (19) | 0 | 10 (40) | 1 (1) | 3 (43) |
| Cause of episode(s),* n | ||||||
| AE | 3 | 15 | 0 | 9 | 0 | 1 |
| Comorbidity or age | 0 | 0 | 0 | 1 | 1 | 2 |
| Others | 2 | 0 | 0 | 0 | 0 | 0 |
| Nilotinib | ||||||
| Median dose per day (mg) | 669 | 800 | 800 | 800 | 800 | 800 |
| Median dose intensity (%) | 84 | 100 | 100 | 100 | 100 | 100 |
| Subjects with episode(s),* n (%) | 45 (50) | 21 (26) | 18 (28) | 7 (28) | 1 (13) | 1(14) |
| No. of episode(s),* n | 55 | 24 | 26 | 8 | 1 | 1 |
| Cause of episode(s),* n | ||||||
| Febrile neutropenia | 11 | 3 | 2 | 0 | 0 | 0 |
| Fever | 1 | 1 | 1 | 0 | 0 | 0 |
| Myalgia | 3 | 0 | 1 | 0 | 0 | 0 |
| Fatigue | 1 | 0 | 0 | 0 | 0 | 0 |
| Headache | 1 | 1 | 0 | 0 | 0 | 0 |
| Cognitive dysfunction | 0 | 1 | 0 | 0 | 0 | 0 |
| Lung infiltration/infection | 5 | 2 | 2 | 0 | 0 | 0 |
| Jaundice | 8 | 5 | 3 | 1 | 1 | 0 |
| Serum ALT elevation | 2 | 2 | 2 | 0 | 0 | 0 |
| Serum lipase elevation | 2 | 0 | 1 | 0 | 0 | 0 |
| Oral mucositis | 0 | 0 | 0 | 1 | 0 | 0 |
| Nausea/vomiting | 6 | 2 | 1 | 0 | 0 | 0 |
| Dyspepsia | 0 | 1 | 0 | 0 | 0 | 0 |
| Pancreatitis | 0 | 0 | 0 | 0 | 0 | 1 |
| Abdominal pain | 3 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 1 | 0 | 3 | 0 | 0 | 0 |
| Ileus | 1 | 2 | 0 | 0 | 0 | 0 |
| Skin rash/itching | 2 | 1 | 2 | 2 | 0 | 0 |
| Edema | 1 | 1 | 0 | 1 | 0 | 0 |
| PSVT/arrhythmia | 1 | 0 | 0 | 0 | 0 | 0 |
| QTc prolongation | 2 | 1 | 0 | 0 | 0 | 0 |
| Palpitation | 0 | 0 | 1 | 0 | 0 | 0 |
| Angina | 0 | 1 | 0 | 0 | 0 | 0 |
| Azotemia | 0 | 0 | 3 | 1 | 0 | 0 |
| Peripheral neuropathy | 0 | 0 | 1 | 0 | 0 | 0 |
| Tremor | 0 | 0 | 1 | 0 | 0 | 0 |
| Cytopenia | 2 | 0 | 1 | 2 | 0 | 0 |
| Bleeding | 1 | 0 | 0 | 0 | 0 | 0 |
| Infection | 0 | 0 | 1 | 0 | 0 | 0 |
| Unknown | 1 | 0 | 0 | 0 | 0 | 0 |
| . | Induction (n = 90) . | Con #1 (n = 80) . | Con #2 (n = 65) . | Con #3 (n = 25) . | Con #4 (n = 8) . | Con #5 (n = 7) . |
|---|---|---|---|---|---|---|
| Cytotoxic drugs | ||||||
| Subjects with episode(s),* n (%) | 5 (6) | 15 (19) | 0 | 10 (40) | 1 (1) | 3 (43) |
| Cause of episode(s),* n | ||||||
| AE | 3 | 15 | 0 | 9 | 0 | 1 |
| Comorbidity or age | 0 | 0 | 0 | 1 | 1 | 2 |
| Others | 2 | 0 | 0 | 0 | 0 | 0 |
| Nilotinib | ||||||
| Median dose per day (mg) | 669 | 800 | 800 | 800 | 800 | 800 |
| Median dose intensity (%) | 84 | 100 | 100 | 100 | 100 | 100 |
| Subjects with episode(s),* n (%) | 45 (50) | 21 (26) | 18 (28) | 7 (28) | 1 (13) | 1(14) |
| No. of episode(s),* n | 55 | 24 | 26 | 8 | 1 | 1 |
| Cause of episode(s),* n | ||||||
| Febrile neutropenia | 11 | 3 | 2 | 0 | 0 | 0 |
| Fever | 1 | 1 | 1 | 0 | 0 | 0 |
| Myalgia | 3 | 0 | 1 | 0 | 0 | 0 |
| Fatigue | 1 | 0 | 0 | 0 | 0 | 0 |
| Headache | 1 | 1 | 0 | 0 | 0 | 0 |
| Cognitive dysfunction | 0 | 1 | 0 | 0 | 0 | 0 |
| Lung infiltration/infection | 5 | 2 | 2 | 0 | 0 | 0 |
| Jaundice | 8 | 5 | 3 | 1 | 1 | 0 |
| Serum ALT elevation | 2 | 2 | 2 | 0 | 0 | 0 |
| Serum lipase elevation | 2 | 0 | 1 | 0 | 0 | 0 |
| Oral mucositis | 0 | 0 | 0 | 1 | 0 | 0 |
| Nausea/vomiting | 6 | 2 | 1 | 0 | 0 | 0 |
| Dyspepsia | 0 | 1 | 0 | 0 | 0 | 0 |
| Pancreatitis | 0 | 0 | 0 | 0 | 0 | 1 |
| Abdominal pain | 3 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 1 | 0 | 3 | 0 | 0 | 0 |
| Ileus | 1 | 2 | 0 | 0 | 0 | 0 |
| Skin rash/itching | 2 | 1 | 2 | 2 | 0 | 0 |
| Edema | 1 | 1 | 0 | 1 | 0 | 0 |
| PSVT/arrhythmia | 1 | 0 | 0 | 0 | 0 | 0 |
| QTc prolongation | 2 | 1 | 0 | 0 | 0 | 0 |
| Palpitation | 0 | 0 | 1 | 0 | 0 | 0 |
| Angina | 0 | 1 | 0 | 0 | 0 | 0 |
| Azotemia | 0 | 0 | 3 | 1 | 0 | 0 |
| Peripheral neuropathy | 0 | 0 | 1 | 0 | 0 | 0 |
| Tremor | 0 | 0 | 1 | 0 | 0 | 0 |
| Cytopenia | 2 | 0 | 1 | 2 | 0 | 0 |
| Bleeding | 1 | 0 | 0 | 0 | 0 | 0 |
| Infection | 0 | 0 | 1 | 0 | 0 | 0 |
| Unknown | 1 | 0 | 0 | 0 | 0 | 0 |
PSVT, paroxysmal supraventricular tachycardia.
Episodes that caused dose reduction or transient interruption of drug.