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Table 3 Summary of treatment-related adverse events overall and by dose level

From: A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer

AE type reported

850 mg/m2

1000 mg/m2

Total

N = 57, n(%)

N = 6, n(%)

N = 63, n(%)

All events

Grade ≥ 3

All events

Grade ≥ 3

All events

Grade ≥ 3

Patients with AEs

46 (81)

30 (53)

6 (100)

2 (33)

52 (83)

32 (51)

AE by term

 Palmar-plantar erythrodysesthesia syndrome

23 (40)

3 (5)

3 (50)

1 (17)

26 (41)

4 (6)

 Hypertension

20 (35)

14 (25)

1 (17)

0 (0)

21 (33)

14 (22)

 Oral Mucositis

8 (14)

2 (4)

4 (67)

1 (17)

12 (19)

3 (5)

 Fatigue

9 (16)

0 (0)

1 (17)

0 (0)

10 (16)

0 (0)

 Proteinuria

9 (16)

2 (4)

NA

NA

9 (14)

2 (3)

 Anorexia

3 (5)

1 (2)

2 (33)

1 (17)

5 (8)

2 (3)

 Nausea

3 (5)

2 (4)

NA

NA

3 (5)

2 (3)

 Platelet count decreased

4 (7)

2 (4)

NA

NA

4 (6)

2 (3)

 Dehydration

2 (4)

2 (4)

NA

NA

2 (3)

2 (3)

 Intracranial Hemorrhage

1 (2)

1 (2)

NA

NA

1 (2)

1 (2)

 Death NOS

1 (2)

1 (2)

NA

NA

1 (2)

1 (2)