Table 2 Most common treatment-emergent adverse events (occurring in > 15% of patients in either treatment arm)

Patients with any AE, n (%)

48 (96.0)

28 (56.0)

50 (98.0)

28 (54.9)

Diarrhoea

28 (56.0)

3 (6.0)

17 (33.3)

0

Fatigue

22 (44.0)

4 (8.0)

17 (33.3)

1 (2.0)

Headache

20 (40.0)

0

11 (21.6)

0

Nausea

18 (36.0)

2 (4.0)

14 (27.5)

0

Decreased appetite

18 (36.0)

1 (2.0)

17 (33.3)

0

Arthralgia

16 (32.0)

1 (2.0)

16 (31.4)

1 (2.0)

Mucosal inflammation

15 (30.0)

0

16 (31.4)

3 (5.9)

Epistaxis

15 (30.0)

0

7 (13.7)

0

Stomatitis

14 (28.0)

1 (2.0)

15 (29.4)

4 (7.8)

Rash

13 (26.0)

0

9 (17.6)

0

Muscle spasms

12 (24.0)

0

5 (9.8)

0

Cough

12 (24.0)

0

8 (15.7)

0

Thrombocytopenia

11 (22.0)

0

1 (2.0)

0

Hyperglycaemia

11 (22.0)

1 (2.0)

13 (25.5)

3 (5.9)

Anaemia

10 (20.0)

1 (2.0)

13 (25.5)

1 (2.0)

Dysgeusia

10 (20.0)

0

5 (9.8)

0

Asthenia

10 (20.0)

1 (2.0)

13 (25.5)

1 (2.0)

Vomiting

10 (20.0)

1 (2.0)

8 (15.7)

0

Platelet count increased

9 (18.0)

3 (6.0)

5 (9.8)

0

Neutropenia

9 (18.0)

2 (4.0)

3 (5.9)

1 (2.0)

Pruritus

9 (18.0)

1 (2.0)

9 (17.6)

0

Urinary tract infection

9 (18.0)

2 (4.0)

9 (17.6)

0

Platelet count decreased

9 (18.0)

3 (6.0)

5 (9.8)

0

Upper abdominal pain

8 (16.0)

1 (2.0)

3 (5.9)

0

Pyrexia

8 (16.0)

1 (2.0)

9 (17.6)

0

ALT increased

8 (16.0)

0

7 (13.7)

2 (3.9)

Dizziness

8 (16.0)

0

4 (7.8)

1 (2.0)

Dyspnoea

7 (14.0)

0

8 (15.7)

1 (2.0)

Hypertension

6 (12.0)

0

8 (15.7)

1 (2.0)

Pneumonitis

5 (10.0)

0

13 (25.5)

3 (5.9)

Constipation

5 (10.0)

0

8 (15.7)

0

AST increased

5 (10.0)

1 (2.0)

8 (15.7)

2 (3.9)

Peripheral oedema

3 (6.0)

0

9 (17.6)

1 (2.0)

Back pain

3 (6.0)

0

9 (17.6)

0