Skip to main content

Table 2 Adverse events (SOC with PT terms occurring in ≥2% of patients with at least one agent)

From: Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry

Exposure (Total, Mean pt.yrs) IFX (n = 389) GLM (n = 421)
1251, 3.2 675, 1.6
SOC/PT N of Events N of Patients % of Patients Rate/100 Pt-Yrs N of Events N of Patients % of Patients Rate/100 Pt-Yrs
TOTAL 1687 264 67.9% 136 882 297 70.5% 131
Eye disorders 65 40 10.3% 5.24 28 22 5.2% 4.15
 Uveitis 15 9 2.3% 1.21 13 9 2.1% 1.93
Gastrointestinal disorders 154 72 18.5% 12.4 56 39 9.3% 8.3
 Diarrhea 24 16 4.1% 1.93 13 12 2.9% 1.93
 Dyspepsia 10 9 2.3% 0.81 3 3 0.7% 0.44
 Nausea 27 19 4.9% 2.18 10 7 1.7% 1.48
 Vomiting 13 12 3.1% 1.05 4 4 1.0% 0.59
General disorders and administration site conditions 154 86 22.1% 12.4 176 156 37.1% 26.1
 Chest pain 18 13 3.3% 1.45 2 2 0.5% 0.3
 Chills 17 8 2.1% 1.37 1 1 0.2% 0.15
 Drug effect decreased 8 7 1.8% 0.64 27 26 6.2% 4.0
 Drug ineffective 12 12 3.1% 0.97 90 88 20.9% 13.3
 Fatigue 26 16 4.1% 2.10 10 9 2.1% 1.48
 Pain 21 16 4.1% 1.69 0 0 0 0
 Pyrexia 12 10 2.6% 0.97 6 5 1.2% 0.89
 Therapeutic response decreased 8 8 2.1% 0.64 25 25 5.9% 3.7
Infections and infestations 408 149 38.3% 32.9 309 129 30.6% 45.8
 Bronchitis 17 11 2.8% 1.37 16 16 3.8% 2.37
 Ear infection 11 11 2.8% 0.89 13 13 3.1% 1.93
 Gastroenteritis 17 15 3.9% 1.37 5 3 0.7% 0.74
 Influenza 15 15 3.9% 1.21 10 8 1.9% 1.48
 Nasopharyngitis 70 44 11.3% 5.64 59 31 7.4% 8.74
 Pneumonia 22 18 4.6% 1.77 8 8 1.9% 1.19
 Sinusitis 37 26 6.7% 2.98 27 18 4.3% 4.00
 Tooth abscess 8 8 2.1% 0.64 3 3 0.7 0.44
 Upper respiratory tract infection 36 28 7.2% 2.90 47 30 7.1% 1.33
 Urinary tract infection 34 19 4.9% 2.74 9 9 2.1% 1.33
Injury, poisoning and procedural complications 89 52 13.4% 7.17 29 25 5.9% 4.3
 Fall 12 10 2.6% 0.97 5 4 1.0% 0.74
 Infusion-related reaction 30 16 4.1% 2.42 0 0 0 0
Investigations 53 38 9.8% 4.27 10 10 2.4% 1.48
 Hepatic enzyme increased 12 11 2.8% 0.97 3 3 0.7% 0.44
Musculoskeletal and connective tissue disorders 263 80 20.6% 21.2 65 45 10.7% 9.63
 Ankylosing spondylitis 11 10 2.6% 0.89 2 2 0.5% 0.30
 Arthralgia 62 31 8.0% 5.00 9 7 1.7% 1.33
 Back pain 53 28 7.2% 4.27 9 9 2.1% 1.33
 Musculoskeletal pain 10 8 2.1% 0.81 2 2 0.5% 0.3
 Neck pain 18 14 3.6% 1.45 3 3 0.7% 0.44
 Pain in extremity 38 20 5.1% 3.06 8 8 1.9% 1.19
Nervous system disorders 80 46 11.8% 6.45 34 29 6.9% 5.04
 Headache 27 21 5.4% 2.18 8 7 1.7% 1.19
 Hypoaesthesia 22 12 3.1% 1.77 2 2 0.5% 0.3
Respiratory, thoracic and mediastinal disorders 99 56 14.4% 7.98 27 19 4.5% 4.00
 Cough 20 17 4.4% 1.61 7 7 1.7% 1.04
 Dyspnoea 12 11 2.8% 0.97 0 0 0 0
 Oropharyngeal pain 22 12 3.1% 1.77 6 5 1.2% 0.89
Skin and subcutaneous tissue disorders 119 63 16.2% 9.59 59 39 9.3% 8.74
 Pruritus 24 19 4.9% 1.93 0 0 0 0
 Psoriasis 15 8 2.1% 1.21 12 9 2.1% 1.33
 Rash 16 12 3.1% 1.29 9 9 2.1% 1.33
Vascular disorders 50 30 7.7% 4.03 9 8 1.9% 1.33
 Hypertension 20 15 3.9% 1.61 6 6 1.4% 0.89