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Table 3 Worst degree of toxic events

From: Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma

 

Treatment

FM(yes/no)

IFN (yes/no)

FM+DTIC (N=62), n(%)

FM+DTIC+IFN (N=67), n(%)

DTIC (N=72), n(%)

DTIC+IFN (N=52), n(%)

p-value

 

0

1

2

3

4

0

1

2

3

4

0

1

2

3

4

0

1

2

3

4

WMW

Fisher

WMW

Fisher

Neutropenia

50(81)

-

7(11)

1(2)

1(2)

37(55)

8(12)

9(13)

7(10)

3(5)

61(85)

1(1)

2(3)

3(4)

2(3)

36(69)

4(8)

4(8)

2(4)

-

0.013

0.421

<0.001

0.192

Febrile/Infection Neutropenia

58(94)

1(2)

-

-

-

62(93)

1(2)

-

-

1(2)

69(96)

-

-

-

-

46(89)

-

-

-

-

0.093

0.973

0.476

0.940

Platelets

45(73)

4(7)

7(11)

2(3)

1(2)

41(61)

7(10)

9(13)

2(3)

5(8)

66(92)

-

2(3)

1(1)

-

42(81)

3(6)

1(2)

-

-

<0.001

0.018

0.030

0.381

Anaemia

55(89)

2(3)

1(2)

1(2)

-

51(76)

5(8)

5(8)

2(3)

1(2)

68(94)

1(1)

-

-

-

44(85)

2(4)

-

-

-

0.002

0.148

0.007

0.510

Nausea/Vomiting

47(76)

9(15)

2(3)

1(2)

-

39(58)

22(33)

2(3)

-

1(2)

53(74)

10(14)

6(8)

-

-

33(64)

7(14)

4(8)

2(4)

-

0.604

0.662

0.039

0.510

Diarrhoea

56(90)

3(5)

-

-

-

60(90)

4(6)

1(2)

-

-

66(92)

3(4)

-

-

-

46(89)

-

-

-

-

0.156

0.604

0.960

0.243

Stomatitis

57(92)

2(3)

-

-

-

63(94)

2(3)

-

-

-

67(93)

1(1)

1(1)

-

-

45(87)

1(2)

-

-

-

0.790

0.604

0.842

0.243

Neurological

57(92)

2(3)

-

-

-

65(97)

-

-

-

-

69(96)

-

-

-

-

46(89)

-

-

-

-

0.174

0.604

0.189

0.243

Hair loss

57(92)

1(2)

-

1(2)

-

62(93)

2(3)

1(2)

-

-

68(94)

-

1(1)

-

-

43(83)

1(2)

-

2(4)

-

0.843

0.953

0.219

0.894

Heart general

59(95)

-

-

-

-

65(97)

-

-

-

-

69(96)

-

-

-

-

46(89)

-

-

-

-

-

0.604

-

0.243

Liver

57(92)

1(2)

-

1(2)

-

61(91)

-

-

2(3)

2(3)

67(93)

-

1(1)

1(1)

-

45(87)

1(2)

-

-

-

0.353

0.247

0.562

0.547

Kidney

59(95)

-

-

-

-

65(97)

-

-

-

-

67(93)

-

1(1)

-

-

46(89)

-

-

-

-

0.301

0.604

0.354

0.243

Pulmonary

59(95)

-

-

-

-

64(96)

1(2)

-

-

-

69(96)

-

-

-

-

46(89)

-

-

-

-

0.340

0.604

0.287

0.243

Allergy

59(95)

-

-

-

-

65(97)

-

-

-

-

69(96)

-

-

-

-

46(89)

-

-

-

-

-

0.604

-

0.243

Fever

58(94)

-

1(2)

-

-

47(70)

7(10)

10(15)

1(2)

-

66(92)

1(1)

1(1)

1(1)

-

34(65)

9(17)

3(6)

-

-

0.535

0.508

<0.001

0.546

Other

58(94)

-

1(2)

-

-

65(97)

-

-

-

-

68(94)

-

-

1(1)

-

43(83)

1(2)

2(4)

-

-

0.141

0.604

0.131

0.243

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Journal of Translational Medicine

ISSN: 1479-5876

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