Table A1.
AEs Leading to Treatment Discontinuation Regardless of Relationship to Study Treatment
| AE | No. of Patients (%) | |
|---|---|---|
| Dasatinib 100 mg Once Daily (n = 258) | Imatinib 400 mg Once Daily (n = 258) | |
| Patients* with any AE† leading to discontinuation | 50 (19) | 26 (10) |
| Pleural effusion | 15 (6) | 1 (< 1) |
| Pulmonary hypertension | 6 (2) | 0 |
| Blast phase in myelogenous leukemia | 3 (1) | 3 (1) |
| Thrombocytopenia | 3 (1) | 2 (1) |
| Dyspnea | 2 (1) | 0 |
| Leukopenia | 2 (1) | 0 |
| Acute myocardial infarction | 2 (1) | 0 |
| Pericardial effusion | 2 (1) | 0 |
| Chest pain | 2 (1) | 0 |
| Diarrhea | 1 (< 1) | 1 (< 1) |
| Acute renal failure | 1 (< 1) | 1 (< 1) |
| Pleuritis | 1 (< 1) | 0 |
| Pneumothorax | 1 (< 1) | 0 |
| Pulmonary embolism | 1 (< 1) | 0 |
| Lung adenocarcinoma | 1 (< 1) | 0 |
| Transitional-cell carcinoma | 1 (< 1) | 0 |
| Peripheral edema | 1 (< 1) | 0 |
| Abdominal discomfort | 1 (< 1) | 0 |
| Abdominal pain | 1 (< 1) | 0 |
| Colitis | 1 (< 1) | 0 |
| Pancreatic disorder | 1 (< 1) | 0 |
| Bronchopneumonia | 1 (< 1) | 0 |
| Infection | 1 (< 1) | 0 |
| Meningoencephalitis, bacterial | 1 (< 1) | 0 |
| Creatine phosphokinase increased | 1 (< 1) | 0 |
| ECG QT prolonged | 1 (< 1) | 0 |
| Diabetes mellitus | 1 (< 1) | 0 |
| Renal failure | 1 (< 1) | 0 |
| Optic neuritis | 1 (< 1) | 0 |
| Blast cell proliferation | 0 | 2 (1) |
| Neutropenia | 0 | 2 (1) |
| Rash | 0 | 2 (1) |
| Colon cancer | 0 | 1 (< 1) |
| Nodal marginal zone B-cell lymphoma | 0 | 1 (< 1) |
| Rectal carcinoma | 0 | 1 (< 1) |
| Myocardial infarction | 0 | 1 (< 1) |
| Asthenia | 0 | 1 (< 1) |
| Performance status decreased | 0 | 1 (< 1) |
| Alopecia | 0 | 1 (< 1) |
| Erythema | 0 | 1 (< 1) |
| Palmar-plantar erythrodysesthesia | 0 | 1 (< 1) |
| Maculopapular rash | 0 | 1 (< 1) |
| ALT increased | 0 | 1 (< 1) |
| AST increased | 0 | 1 (< 1) |
| Hypocalcemia | 0 | 1 (< 1) |
| Hypophosphatemia | 0 | 1 (< 1) |
| Cytogenetic abnormality | 0 | 1 (< 1) |
| Toxic hepatitis | 0 | 1 (< 1) |
Abbreviation: AE, adverse event.
*
Patients may have had more than one AE.
†
AEs listed were reported by investigators at the time of treatment discontinuation and were defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient. AEs did not necessarily have a causal relationship with study treatment.