Table 3 AEs.

From: A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer

AEs

ABX+DDP (n = 127)

GEM+DDP (n = 126)

 

All grade (n/%)

Grade 3 (n/%)

Grade 4 (n/%)

Grade 3/4 (n/%)

All grade (n/%)

Grade 3 (n/%)

Grade 4 (n/%)

Grade 3/4 (n/%)

Anemia

114 (89.7)

19 (15)

0 (0)

19 (15)

107 (84.9)

14 (11)

1 (0.8)

15 (11.9)

Neutropenia

121 (95.3)

35 (27.6)

17 (13.4)

52 (40.9)

109 (86.5)

36 (28.3)

15 (11.8)

51 (40.5)

Febrile neutropenia

6 (4.7)

6 (4.7)

0 (0)

6 (4.7)

4 (3.2)

4 (3.1)

0 (0)

4 (3.2)

Thrombocytopenia

20 (15.7)

4 (3.1)

1 (0.8)

5 (3.9)

66 (52.4)

21 (16.5)

16 (12.6)

37 (29.4)

Neuropathy

80 (63.0)

24 (18.9)

0 (0)

24 (18.9)

22 (17.5)

0 (0)

0 (0)

0 (0)

Diarrhea

18 (14.2)

1 (0.8)

0 (0)

1 (0.8)

3 (2.4)

0 (0)

0 (0)

0 (0)

Anorexia

26 (20.5)

1 (0.8)

0 (0)

1 (0.8)

10 (7.9)

0 (0)

0 (0)

0 (0)

Fatigue

44 (34.6)

0 (0)

0 (0)

0 (0)

37 (29.4)

1 (0.8)

0 (0)

1 (0.8)

Rash

23 (18.1)

0 (0)

0 (0)

0 (0)

17 (13.5)

0 (0)

0 (0)

0 (0)

Blurred vision

6 (4.7)

0 (0)

0 (0)

0 (0)

4 (3.2)

0 (0)

0 (0)

0 (0)

ALT/AST increased

20 (15.7)

1 (0.8)

0 (0)

1 (0.8)

23 (18.2)

0 (0)

0 (0)

0 (0)

Nausea or vomiting

84 (66.1)

8 (6.3)

0 (0)

8 (6.3)

75 (59.5)

1 (0.8)

0 (0)

1 (0.8)

Edema

5 (3.9)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Myalgia

18 (14.2)

0 (0)

0 (0)

0 (0)

13 (10.3)

0 (0)

0 (0)

0 (0)

Creatinine increased

20 (15.7)

0 (0)

0 (0)

0 (0)

17 (13.5)

0 (0)

0 (0)

0 (0)

Hypomagnesaemia

35 (27.5)

2 (1.6)

0 (0)

2 (1.6)

27 (21.4)

0 (0)

0 (0)

0 (0)

Hypokalemia

21 (16.5)

2 (1.6)

1 (0.8)

1 (0.8)

17 (13.5)

0 (0)

0 (0)

1 (0.8)

Hyponatremia

24 (18.9)

4 (3.1)

0 (0)

4 (3.1)

22 (17.5)

1 (0.8)

0 (0)

1 (0.8)

Hypocalcemia

22 (17.3)

0 (0)

0 (0)

0 (0)

23 (18.2)

1 (0.8)

0 (0)

1 (0.8)

  1. ALT alanine aminotransferase, AST aspartate aminotransferase. Data are n (%) from the safety population. There were no grade 5 drug-related AEs.