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Table 2 Adverse events graded according to NCI CTC AE V.4.03 registered in at least 10% of the patients related to the study drugs

From: Nintedanib plus letrozole in early breast cancer: a phase 0/I pharmacodynamic, pharmacokinetic, and safety clinical trial of combined FGFR1 and aromatase inhibition

 

Level 1

Level 2

Total

Grades 1–2

Grade 3

Grade 1–2

Grade 3

Nintedanib-related event

 Diarrhea

1/3 (33%)

0/3 (0%)

9/16 (56%)

3/16 (18.8%)

13/19 (68%)

 Nausea

2/3 (66.6%)

0/3 (0%)

9/16 (56%)

0/16 (0%)

11/19 (58%)

 Vomiting

2/3 (66.6%)

0/3 (0%)

9/16 (56%)

0/16 (0%)

11/19 (58%)

 Asthenia

1/3 (33%)

1/3 (33%)

9/16 (56%)

0/16 (0%)

11/19 (58%)

 Elevated GGT

0/3 (0%)

0/3 (0%)

4/16 (25%)

4/16 (25%)

8/19 (42%)

 Elevated AST

1/3 (33%)

0/3 (0%)

4/16 (25%)

2/16 (12.5%)

7/19 (36.8%)

 Elevated ALT

0/3 (0%)

0/3 (0%)

4/16 (25%)

2/16 (12.5%)

6/19 (31.5%)

 Hyporexia

0/3 (0%)

0/3 (0%)

3/16 (18.8%)

0/16 (0%)

3/19 (15.8%)

 Dysgeusia

1/3 (33%)

0/3 (0%)

2/16 (12.5%)

0/16 (0%)

3/19 (15.8%)

 Hypertension

0/3 (0%)

0/3 (0%)

0/16 (0%)

2/16 (12.5%)

2/19 (10.5%)

 Headache

1/3 (33%)

0/3 (0%)

1/16 (6.2%)

0/16 (0%)

2/19 (10.5%)

Letrozole-related event

 Asthenia

2/3 (66.6%)

0/3 (0%)

8/16 (50%)

0/16 (0%)

10/19 (52.6%)

 Arthralgia

1/3 (33%)

0/3 (0%)

7/16 (43.8%)

0/16 (0%)

8/19 (42%)

 Hot flushes

1/3 (33%)

0/3 (0%)

6/16 (37.5%)

0/16 (0%)

7/19 (36.8%)