Table 2 AEs reported in more than five patients.

From: Phase 1 trial of ADI-PEG20 plus cisplatin in patients with pretreated metastatic melanoma or other advanced solid malignancies

 

Dose-escalation cohorts, N (%)

RP2D-expansion cohorts, N (%)

 
 

1

2

3

4

5A

5B

H

B

C

O

U

 

Patient characteristics

N = 3

N = 6

N = 5

N = 3

N = 2

N = 4

N = 22

N = 9

N = 16

N = 20

N = 9

All patients, N (%)

Anaemia

1 (33)

2 (33)

3 (60)

1 (33)

0

2 (50)

12 (55)

5 (56)

11 (69)

10 (50)

6 (67)

53 (54)

Leukopenia

0

2 (33)

1 (20)

1 (33)

2 (100)

4 (100)

6 (27)

3 (33)

11 (69)

14 (70)

6 (67)

50 (51)

Neutropenia

1 (33)

2 (33)

1 (20)

2 (67)

2 (100)

4 (100)

6 (27)

2 (22)

9 (56)

16 (80)

5 (56)

50 (51)

Thrombocytopenia

1 (33)

2 (33)

5 (100)

2 (67)

2 (100)

3 (75)

7 (32)

3 (33)

11 (69)

8 (40)

6 (67)

50 (51)

Nausea

0

4 (67)

2 (40)

2 (67)

1 (50)

3 (75)

9 (41)

3 (33)

7 (44)

6 (30)

5 (56)

42 (42)

Fatigue

0

3 (50)

3 (60)

1 (33)

1 (50)

3 (75)

9 (41)

1 (11)

6 (38)

6 (30)

6 (67)

39 (39)

Hypoalbumonaemia

0

1 (17)

1 (20)

1 (33)

1 (50)

0

5 (23)

2 (22)

5 (31)

7 (35)

3 (33)

26 (26)

Hyponatremia

1 (33)

1 (17)

2 (40)

1 (33)

2 (100)

0

4 (18)

3 (33)

4 (25)

6 (30)

2 (22)

26 (26)

Constipation

0

2 (33)

0

1 (33)

0

1 (25)

6 (27)

2 (22)

5 (31)

3 (15)

4 (44)

24 (24)

Hyperkalaemia

0

1 (17)

0

1 (33)

0

0

5 (23)

2 (22)

3 (19)

6 (30)

6 (67)

24 (24)

Vomiting

0

4 (67)

3(60)

1 (33)

0

1 (25)

4 (18)

1 (11)

3 (19)

3 (15)

0

20 (20)

  1. B HCC with BTC or BTC alone, C cutaneous melanoma, H HCC, O ovarian carcinoma, U uveal melanoma.
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