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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%)