Table 2.

Vinorelbine-associated AEs by SOC classification in the FAERS database.

SOC	Report count	ROR (95% CI)	IC (IC025)
General disorders and administration site conditions	995	0.82 (0.76–0.87)	-0.24 (-0.34)
Gastrointestinal disorders	744	1.34 (1.24–1.44)	0.38 (0.26)
Blood and lymphatic system disorders	625	5.93 (5.46–6.44)	2.45 (2.32)
Respiratory, thoracic and mediastinal disorders	596	1.96 (1.80–2.13)	0.91 (0.78)
Investigations	561	1.39 (1.27–1.51)	0.44 (0.31)
Nervous system disorders	449	0.77 (0.70–0.85)	-0.35 (-0.49)
Infections and infestations	391	1.12 (1.01–1.24)	0.15 (0.00)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	300	1.72 (1.53–1.93)	0.76 (0.58)
Cardiac disorders	282	1.61 (1.43–1.81)	0.66 (0.49)
Skin and subcutaneous tissue disorders	245	0.66 (0.58–0.75)	-0.57 (-0.76)
Metabolism and nutrition disorders	242	1.68 (1.48–1.91)	0.73 (0.53)
Vascular disorders	190	1.33 (1.15–1.54)	0.40 (0.19)
Renal and urinary disorders	185	1.45 (1.25–1.68)	0.52 (0.30)
Musculoskeletal and connective tissue disorders	177	0.49 (0.42–0.57)	-0.99 (-1.20)
Hepatobiliary disorders	107	1.73 (1.43–2.1)	0.78 (0.49)
Psychiatric disorders	96	0.24 (0.20–0.30)	-1.99 (-2.27)
Eye disorders	80	0.59 (0.47–0.74)	-0.75 (-1.07)
Immune system disorders	42	0.56 (0.41–0.76)	-0.83 (-1.26)
Ear and labyrinth disorders	35	1.20 (0.86–1.67)	0.26 (-0.23)
Endocrine disorders	30	1.74 (1.22–2.50)	0.80 (0.25)
Pregnancy, puerperium and perinatal conditions	17	0.58 (0.36–0.94)	-0.77 (-1.42)
Reproductive system and breast disorders	12	0.20 (0.11–0.35)	-2.32 (-3.03)