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Table 5 Incidence of severe adverse events according to treatment arm (as treated)

From: Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial

 

Arm A: E-T-CMF

Arm B: E-CMF-wD

Arm C: E-CMF-wT

N = 326

N = 316

N = 320

Grade III

Grade IV

Grade V

Grade III

Grade IV

Grade V

Grade III

Grade IV

Grade V

 

N

(%)

N

(%)

N

(%)

N

(%)

N

(%)

N

(%)

N

(%)

N

(%)

N

(%)

Hemoglobin

6

1.8

    

3

0.9

    

6

1.9

    

Leucocytes

28

8.6

11

3.4

  

36

11.4

5

1.6

  

32

10.0

7

2.2

  

Lymphopenia

2

0.6

    

4

1.3

    

1

0.3

    

Neutrophils

55

16.9

44

13.5

  

61

19.3

24

7.6

  

49

15.3

36

11.3

  

Platelets

1

0.3

1

0.3

  

1

0.3

1

0.3

  

3

0.9

1

0.3

  

Febrile neutropenia

17

5.2

2

0.6

1

0.3

12

3.8

1

0.3

1

0.3

13

4.1

4

1.3

  

Gastrointestinal

      

4

1.3

    

4

1.3

    

Metabolic/laboratory

12

3.7

    

7

2.2

1

0.3

  

16

5.0

5

1.6

  

Dermatology/skin1

5

1.5

    

9

2.8

    

1

0.3

    

Pain2

17

5.2

    

3

0.9

    

5

1.6

    

Pulmonary/Upper respiratory

  

2

0.6

  

2

0.6

1

0.3

1

0.3

1

0.3

    

Constitutional

      

1

0.3

    

1

0.3

    

Fatigue

4

1.2

    

7

2.2

    

9

2.8

1

0.3

  

Diarrhea

3

0.9

    

8

2.5

    

3

0.9

    

Nausea

7

2.1

    

6

1.9

    

10

3.1

    

Neurology3

16

4.9

    

4

1.3

    

4

1.3

    

Vomiting

5

1.5

    

5

1.6

1

0.3

  

4

1.3

    

Mucositis

6

1.8

1

0.3

  

17

5.4

    

10

3.1

    

Infection

7

2.1

  

1

0.3

15

4.7

    

7

2.2

    

Occular

      

2

0.6

          

Allergy4

8

2.5

            

2

0.6

  

Edema

      

1

0.3

          

Vascular

2

0.6

    

3

0.9

    

7

2.2

  

1

0.3

Cardiac

  

1

0.3

  

2

0.6

    

1

0.3

  

1

0.3

Anorexia

      

1

0.3

          
  1. 1 P = 0.020 (Fisher’s test); 2 P = 0.002; 3 P = 0.004; 4 P = 0.004.
  2. N number of patients.