Table 3 Total adverse events reported during the initial 12 months of treatment^a

Mucositis

49 (43.8)

81 (41.5)

1.095 (0.648–1.751)^b

Upper respiratory infection

30 (26.8)

51 (26.2)

0.033 (0.610–1.748)^b

Nausea/vomiting

28 (25.0)

50 (25.6)

0.967 (0.566–1.651)^b

Pneumonia^b

26 (23.2)

48 (24.6)

0.926 (0.536–1.599)^b

Thrombocytosis

22 (19.6)

37 (19.0)

1.044 (0.580–1.879)^b

Cough

18 (16.1)

30 (15.4)

1.053 (0.557–1.991)^b

Eczema

15 (13.4)

29 (14.9)

0.885 (0.452–1.733)^b

Diarrhea

16 (14.3)

25 (12.8)

1.133 (0.577–2.227)^b

Increased liver enzyme levels

11 (9.8)

22 (11.3)

0.856 (0.399–1.839)^b

Constipation

12 (10.7)

20 (10.3)

1.050 (0.493–2.238)^b

Rash

7 (6.3)

16 (8.2)

0.746 (0.297–1.872)^b

Pain

6 (5.4)

12 (6.2)

0.863 (0.315–2.367)^b

Gastroenteritis

6 (5.4)

10 (5.1)

1.047 (0.370–2.962)^b

Cutaneous infection

5 (4.5)

11 (5.6)

0.782 (0.264–2.310)^b

Acne

5 (4.5)

10 (5.1)

0.864 (0.288–2.596)^b

Decreased appetite

5 (4.5)

9 (4.6)

0.966 (0.315–2.956)^b

Lymphopenia

4 (3.6)

10 (5.1)

0.685 (0.210–2.238)^c

Lymph gland infection

4 (3.6)

7 (3.6)

0.955 (0.285–3.476)^c

Hyperlipidemia

3 (2.7)

8 (4.1)

0.643 (0.167–2.476)^c

Hyperhidrosis

3 (2.7)

5 (2.6)

1.046 (0.245–4.461)^c

Delay wound healing

2 (1.8)

5 (2.6)

0.691 (0.132–3.621)^c

Hypercholesterolemia

2 (1.8)

3 (1.5)

1.164 (0.191–7.071)^c

Urinary tract infection

2 (1.8)

3 (1.5)

1.164 (0.191–7.071)^c

Alopecia

2 (1.8)

2 (1.0)

1.755 (0.244–12.630)^c

Anemia

1 (0.9)

2 (1.0)

0.869 (0.078–9.697)^c

Neutropenia

1 (0.9)

0 (0)

0.991 (0.974–1.009)^c

Peripheral edema

0 (0)

1 (0.5)

1.005 (0.995–1.015)^c

Total

285

507

N/A