Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): Results from the CanACT study

Table 4 Proportion and Rates of Adverse Events that are Probably or Possibly Related to Adalimumab Observed in More Than 1% of the Patients

Adverse events observed in > 1% of the patients (probably or possibly related to adalimumab)	No. of Events	No. of Patients	Patients (%)	Events per 100 patient-years
Injection site reaction NOS^a	145	87	9.9	39.0
Headache	63	46	5.2	16.9
Injection site erythema	55	31	3.5	14.8
Nausea	38	26	3	10.2
Rash NOS	26	25	2.8	7.0
Diarrhea NOS	27	22	2.5	7.3
Fatigue	21	16	1.8	5.6
Upper respiratory tract infection NOS	17	16	1.8	4.6
Injection site pruritus	23	13	1.5	6.2
Dizziness	12	12	1.4	3.2
Pruritus	14	12	1.4	3.8
Rheumatoid arthritis	14	12	1.4	3.8
Nasopharyngitis	13	11	1.3	3.5
Adverse drug reaction	11	10	1.1	3.0
Injection site rash	11	10	1.1	3.0
Urinary tract infection NOS	10	9	1	2.7

^aDefined as localized injection-site bruising, burning, dermatitis, erythema, induration, inflammation, irritation, mass, edema, pain, pruritus, rash, stinging, swelling, and warmth.
NOS: not otherwise specified.

ISSN: 1471-2474