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Table 3 Hematologic and non-hematologic toxicities of safety population

From: Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial

 

BP Group (n = 70)

EP Group (n = 77)

P

Gradea, n (%)

Gradea, n (%)

1

2

3

4

≥3

1

2

3

4

≥ 3

Febrile neutropenia

0(0.0)

0(0.0)

7(10.0)

4(5.7)

11(15.7)

0(0.0)

0(0.0)

6(7.8)

0(0.0)

6(7.8)

0.196

Anemia

3(4.3)

30(42.9)

21(30.0)

3(4.3)

24(34.3)

13(16.9)

33(42.9)

10(13.0)

0(0.0)

10(13.0)

0.003

Leukopenia

3(4.3)

13(18.6)

23(32.9)

19(27.1)

42(60.0)

5(6.5)

17(22.1)

25(32.5)

10(13.0)

35(45.5)

0.098

Neutropenia

1(1.4)

3(4.3)

11(15.7)

43(61.4)

54(77.1)

2(2.6)

9(11.7)

14(18.2)

38(49.4)

52(67.5)

0.204

Thrombocytopenia

2(2.9)

14(20.0)

21(30.0)

17(24.3)

38(54.3)

13(16.9)

4(5.2)

7(9.1)

6(7.8)

13(16.9)

< 0.001

Anorexia

7(10.0)

13(18.6)

1(1.4)

0(0.0)

1(1.4)

6(7.8)

9(11.7)

1(1.3)

0(0.0)

1(1.3)

1.000

Nausea

12(17.1)

12(17.1)

2(2.9)

0(0.0)

2(2.9)

10(13.0)

7(9.1)

2(2.6)

0(0.0)

2(2.6)

1.000

Vomiting

8(11.4)

5(7.1)

1(1.4)

0(0.0)

1(1.4)

4(5.2)

3(3.9)

0(0.0)

0(0.0)

0(0.0)

0.473

Weight loss

0(0.0)

0(0.0)

1(1.4)

0(0.0)

1(1.4)

0(0.0)

3(3.9)

1(1.3)

0(0.0)

1(1.3)

1.000

Anxiety

1(1.4)

2(2.9)

2(2.9)

0(0.0)

2(2.9)

3(3.9)

3(3.9)

0(0.0)

0(0.0)

0(0.0)

0.473

Diarrhea

14(20.0)

7(10.0)

2(2.9)

0(0.0)

2(2.9)

8(10.4)

2(2.6)

1(1.3)

0(0.0)

1(1.3)

0.605

Fatigue

8(11.4)

11(15.7)

4(5.2)

0(0.0)

4(5.2)

18(23.4)

12(15.6)

3(3.9)

0(0.0)

3(3.9)

0.498

Infection

0(0.0)

0(0.0)

9(12.9)

3(4.3)

13(18.6)

0(0.0)

4(5.2)

5(6.5)

0(0.0)

10(13.0)

0.577

Hepatic dysfunction

1(1.4)

5(7.1)

2(2.9)

0(0.0)

2(2.9)

4(5.2)

3(3.9)

4(5.2)

2(2.6)

6(7.8)

0.621

Hyperglycemia

0(0.0)

4(5.7)

2(2.9)

0(0.0)

2(2.9)

0(0.0)

3(3.9)

4(5.2)

1(1.3)

5(6.5)

0.446

Hyponatremia

1(1.4)

0(0.0)

6(8.6)

6(8.6)

12(17.1)

0(0.0)

1(1.3)

6(7.8)

3(3.9)

9(11.7)

0.631

Hyperkalemia

0(0.0)

0(0.0)

2(2.9)

0(0.0)

2(2.9)

0(0.0)

1(1.3)

3(3.9)

0(0.0)

3(3.9)

1.000

Hypokalemia

0(0.0)

0(0.0)

3(4.3)

0(0.0)

3(4.3)

1(1.3)

0(0.0)

1(1.3)

0(0.0)

1(1.3)

0.347

  1. aGrade means the maximum grade of toxicity. Grade 5 toxicities were developed by infection (1 patient in BP arm and 5 patients in EP arm) and disease progression (2 patients in EP arm)
  2. P value was calculated by Fisher’s exact test for grade ≥ 3 toxicity