Table 2 Incidence of NCI-CTCAEs up to one day post study treatment (all-treated population)

Patients with at least one AE, n (%)

37 (97.4)

9 (23.7)

1 (2.6)

38 (100)**

14 (36.8)

1 (2.6)

Patients with AE,* n (%)

   Nausea

19 (50.0)

-

-

22 (57.9)

1 (2.6)

-

   Fatigue

19 (50.0)

-

-

14 (36.8)

2 (5.3)

-

   Constipation

10 (26.3)

-

-

12 (31.6)

-

-

   Vomiting

8 (21.1)

-

-

12 (31.6)

2 (5.3)

-

   Thrombocytopenia

4 (10.5)

1 (2.6)

-

9 (23.7)

2 (5.3)

1 (2.6)

   Headache

11 (28.9)

1 (2.6)

-

7 (18.4)

-

-

   Anemia

1 (2.6)

-

-

7 (18.4)

2 (5.3)

1 (2.6)

   Anorexia

7 (18.4)

-

-

6 (15.8)

-

-

   Diarrhea

7 (18.4)

-

-

6 (15.8)

-

-

   Neutropenia

5 (13.2)

2 (5.3)

1 (2.6)

6 (15.8)

5 (13.2)

-

   Lethargy

2 (5.3)

-

-

6 (15.8)

-

-

   Dyspnea

9 (23.7)

3 (7.9)

-

5 (13.2)

2 (5.3)

-

   Cough

6 (15.8)

-

-

5 (13.2)

-

-

   Pain in extremity

4 (10.5)

1 (2.6)

-

5 (13.2)

1 (2.6)

-

   Edema peripheral

3 (7.9)

-

-

5 (13.2)†

-

-

   Insomnia

5 (13.2)

-

-

4 (10.5)

-

-

Alanine aminotransferase

increased

3 (7.9)

-

-

4 (10.5)

1 (2.6)

-