Table 3 Cumulative rate of patients with adverse events of special interest, by year.

From: Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial

n (%)

Bosutinib (n = 268)

Imatinib (n = 265)

Year 1

Year 2

Year 3

Year 4

Year 5+

Year 1

Year 2

Year 3

Year 4

Year 5+

Cardiaca

13 (4.9)

17 (6.3)

20 (7.5)

22 (8.2)

26 (9.7)

11 (4.2)

14 (5.3)

16 (6.0)

19 (7.2)

23 (8.7)

Vascularb

9 (3.4)

15 (5.6)

17 (6.3)

19 (7.1)

20 (7.5)

4 (1.5)

4 (1.5)

7 (2.6)

8 (3.0)

9 (3.4)

 Cardiovascular

6 (2.2)

10 (3.7)

10 (3.7)

12 (4.5)

13 (4.9)

0

0

1 (0.4)

1 (0.4)

1 (0.4)

 Cerebrovascular

0

0

2 (0.7)

2 (0.7)

2 (0.7)

1 (0.4)

1 (0.4)

2 (0.8)

3 (1.1)

3 (1.1)

 Peripheral vascular

3 (1.1)

5 (1.9)

5 (1.9)

5 (1.9)

6 (2.2)

3 (1.1)

3 (1.1)

5 (1.9)

5 (1.9)

6 (2.3)

Effusionc

6 (2.2)

8 (3.0)

12 (4.5)

16 (6.0)

16 (6.0)

4 (1.5)

4 (1.5)

4 (1.5)

4 (1.5)

6 (2.3)

 Pleural effusion

5 (1.9)

7 (2.6)

11 (4.1)

14 (5.2)

14 (5.2)

4 (1.5)

4 (1.5)

4 (1.5)

4 (1.5)

5 (1.9)

 Pericardial effusion

1 (0.4)

2 (0.7)

3 (1.1)

4 (1.5)

5 (1.9)

0

0

0

0

1 (0.4)

Renald

16 (6.0)

21 (7.8)

22 (8.2)

26 (9.7)

28 (10.4)

16 (6.0)

22 (8.3)

23 (8.7)

23 (8.7)

26 (9.8)

  1. CNS central nervous system, HLGT high-level group term, HLT high-level term, MedDRA Medical Dictionary for Regulatory Activities, NEC not elsewhere classified, PT preferred term, SMQ standardized MedDRA query, TEAE treatment-emergent adverse event.
  2. aIncludes the MedDRA HLGT: Cardiac arrhythmias, Heart failures; PT: Cardiac death, Sudden cardiac death, Sudden death, Ejection fraction decreased; SMQ: Torsade de pointes/QT prolongation (narrow).
  3. bVascular includes MedDRA terms for cardiovascular, cerebrovascular, and peripheral vascular TEAEs:
  4. • Cardiovascular: HLGT: Coronary artery disorders; HLT: Arterial therapeutic procedures (excluding aortic), Vascular imaging procedures NEC, Vascular therapeutic procedures NEC; PT: Transcatheter arterial chemoembolization.
  5. • Cerebrovascular: HLT: CNS hemorrhages and cerebrovascular accidents, CNS vascular disorders NEC, Transient cerebrovascular events.
  6. • Peripheral vascular: HLGT: Arteriosclerosis, stenosis, vascular insufficiency, and necrosis; Embolism and thrombosis; HLT: Non-site-specific vascular disorders NEC, Peripheral vascular disorders NEC (excluding PTs flushing and hot flush); PT: Intestinal ischemia.
  7. cIncludes the MedDRA PT: Pericardial effusion, Pleural effusion.
  8. dIncludes the MedDRA HLT: Renal failure and impairment; PT: Blood creatinine abnormal, Blood creatinine increased, Creatinine renal clearance abnormal, Creatinine renal clearance decreased, Glomerular filtration rate abnormal, Glomerular filtration rate decreased.
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