Table 5.

Treatment-related adverse events.

	biosimilar group (n=551)		reference group (n=395)
Adverse events	any grade	Grade 3-4	any grade	Grade 3-4
General disorders
fatigue	56 (10.16%)	7 (1.27%)	47 (11.90%)	4 (1.01%)
fever	48 (8.71%)	18 (3.27%)	22 (5.57%)	9 (2.28%)
Infectious diseases
pneumonia	7 (1.27%)	2 (0.36%)	3 (0.76%)	0 (0.00%)
Blood and lymphatic system disorders
anemia	89 (16.15%)	2 (0.36%)	65 (16.46%)	2 (0.51%)
leucopenia	36 (6.53%)	3 (0.54%)	21 (5.32%)	4 (1.01%)
neutropenia	126 (22.87%)	67 (12.16%)	95 (24.05%)	42 (10.63%)
thrombocytopenia	56 (10.16%)	11 (2.00%)	43 (10.89%)	5 (1.27%)
Vascular disorders
hypertension	53 (9.62%)*	9 (1.63%)	23 (5.82%)*	2 (0.51%)
bleeding	39 (7.08%)	5 (0.91%)	29 (7.34%)	4 (1.01%)
thromboembolism	3 (0.54%)	0 (0.00%)	2 (0.51 %)	0 (0.00%)
Urinary disorders
creatinine increased	10 (1.81%)	2 (0.36%)	9 (2.28%)	6 (1.52%)
proteinuria	5 (0.91%)	3 (0.54%)	6 (1.52%)	2 (0.51%)
Respiratory disorders
cough	2 (0.36%)	1 (0.18%)	0 (0.00%)	0 (0.00%)
Gastrointestinal disorders
diarrhea	3 (0.54%)	0 (0.00%)	1 (0.25%)	1 (0.25%)
nausea	71 (12.89%)	6 (1.09%)	42 (10.63%)	3 (0.76%)
vomiting	34 (6.17%)	3 (0.54%)	17 (4.30%)	3 (0.76%)
intestinal obstruction	2 (0.36%)	0 (0.00%)	0 (0.00%)	0 (0.00%)
elevated ALT or AST	14 (2.54%)	6 (1.09%)	7 (1.77%)	3 (0.76%)
Nervous system disorders
headache	13 (2.36%)	1 (0.18%)	11 (2.78%)	1 (0.25%)
paresthesia	3 (0.54%)	0 (0.00%)	1 (0.25%)	0 (0.00%)
Skin and subcutaneous tissue disorders
hair loss	81 (14.70%)	2 (0.36%)	54 (13.67%)	1 (0.25%)
rash	7 (1.27%)	0 (0.00%)	3 (0.76%)	2 (0.51%)
Musculoskeletal connective tissue disorders
joint pain	2 (0.36%)	1 (0.18%)	1 (0.25%)	0 (0.00%)
Metabolism and nutrition disorders
poor appetite	42 (7.62%)	1 (0.18%)	37 (9.37%)	2 (0.51%)
Total	421 (76.41%)	122 (22.14%)	283 (71.65%)	77 (19.49%)

Number of patients with an event (percent). *p < 0.05; ALT, alanine aminotransferase; AST, aspartate transaminase.