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Table 4 Treatment-related adverse events occurring in mCRC patients during the study in the safety analysis set

From: Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial

Adverse event Famitinib group [cases (%)] (n = 99) Placebo group [cases (%)] (n = 55)
Any grade Grade 3–4 Any grade Grade 3–4
Any eventa 92 (92.9) 51 (51.5) 42 (76.4) 20 (36.4)
Clinical adverse event
 Hypertension 38 (38.4) 11 (11.1) 4 (7.3) 1 (1.8)
 Hand-foot syndrome 27 (27.3) 10 (10.1) 1 (1.8) 0 (0.0)
 Diarrhea 15 (15.2) 1 (1.0) 3 (5.5) 0 (0.0)
 Fatigue 14 (14.1) 3 (3.0) 9 (16.4) 2 (3.6)
 Rash 8 (8.1) 2 (2.0) 0 (0.0) 0 (0.0)
 Hypothyroidism 7 (7.1) 0 (0.0) 1 (1.8) 0 (0.0)
 Oral mucositis 7 (7.1) 0 (0.0) 0 (0.0) 0 (0.0)
 Nausea 6 (6.1) 0 (0.0) 4 (7.3) 1 (1.8)
 Decrease appetite 6 (6.1) 0 (0.0) 5 (9.1) 0 (0.0)
 Headache 6 (6.1) 1 (1.0) 2 (3.6) 1 (1.8)
 Vomit 5 (5.1) 1 (1.0) 2 (3.6) 1 (1.8)
 Dizziness 5 (5.1) 0 (0.0) 2 (3.6) 0 (0.0)
 Backache 3 (3.0) 0 (0.0) 3 (5.5) 0 (0.0)
 Abdominal distension 2 (2.0) 0 (0.0) 3 (5.5) 0 (0.0)
 Cough 2 (2.0) 0 (0.0) 5 (9.1) 0 (0.0)
Laboratory abnormalities
 Proteinuria 42 (42.4) 6 (6.1) 9 (16.4) 0 (0.0)
 Neutropenia 41 (41.4) 9 (9.1) 1 (1.8) 1 (1.8)
 Leukopenia 36 (36.4) 3 (3.0) 1 (1.8) 0 (0.0)
 Thrombocytopenia 31 (31.3) 10 (10.1) 1 (1.8) 1 (1.8)
 Increased γ-GT 20 (20.2) 7 (7.1) 11 (20.0) 7 (12.7)
 Increased ALT 17 (17.2) 3 (3.0) 8 (14.5) 1 (1.8)
 Increased AST 16 (16.2) 2 (2.0) 7 (12.7) 0 (0.0)
 Increased ALP 14 (14.1) 0 (0.0) 6 (10.9) 2 (3.6)
 Hypercholesterolemia 11 (11.1) 0 (0.0) 2 (3.6) 0 (0.0)
 Hypertriglyceridemia 11 (11.1) 0 (0.0) 2 (3.6) 0 (0.0)
 Anemia 7 (7.1) 0 (0.0) 4 (7.3) 1 (1.8)
 Increase bilirubin 5 (5.1) 1 (1.0) 1 (1.8) 0 (0.0)
 Hyperglycemia 1 (1.0) 0 (0.0) 3 (5.5) 1 (1.8)
  1. γ-GT γ-glutamyltranspeptidase, ALT alanine transaminase, AST aspartate transaminase, ALP alkaline phosphatase
  2. aSome patients had experienced several AEs