Table 5.
Adverse events (preferred term; ≥2 patients with one agent)
| IFX (N = 890) | GLM (N = 530) | GLM-IV (N = 157) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N of Events | N of Patients | % of Patients | Rate/100 Pt-Yrs | N of Events | N of Patients | % of Patients | Rate/100 Pt-Yrs | N of Events | N of Patients | % of Patients | Rate/100 Pt-Yrs | |
| Gastrointestinal disorders | ||||||||||||
| Diarrhea | 27 | 20 | 2.2% | 0.94 | 12 | 12 | 2.3% | 1.11 | 1 | 1 | 0.6% | 0.39 |
| Nausea | 54 | 44 | 4.9% | 1.87 | 13 | 12 | 2.3% | 1.21 | 2 | 2 | 1.3% | 0.78 |
| Vomiting | 23 | 20 | 2.2% | 0.80 | 7 | 7 | 1.3% | 0.65 | 1 | 1 | 0.6% | 0.39 |
| General disorders and administration site conditions | ||||||||||||
| Chest discomfort | 26 | 22 | 2.5% | 0.90 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chest pain | 21 | 19 | 2.1% | 0.73 | 2 | 2 | 0.4% | 0.19 | 1 | 1 | 0.6% | 0.39 |
| Drug effect decreased | 5 | 5 | 0.6% | 0.17 | 22 | 22 | 4.2% | 2.04 | 6 | 6 | 3.8% | 2.34 |
| Drug ineffective | 19 | 19 | 2.1% | 0.66 | 64 | 63 | 11.9% | 5.94 | 23 | 23 | 14.6% | 8.96 |
| Fatigue | 41 | 33 | 3.7% | 1.42 | 5 | 5 | 0.9% | 0.46 | 3 | 3 | 1.9% | 1.17 |
| Influenza-like illness | 15 | 11 | 1.2% | 0.52 | 16 | 15 | 2.8% | 1.49 | 3 | 3 | 1.9% | 1.17 |
| Pain | 23 | 20 | 2.2% | 0.80 | 3 | 3 | 0.6% | 0.28 | 0 | 0 | 0 | 0 |
| Pyrexia | 27 | 26 | 2.9% | 0.94 | 4 | 4 | 0.8% | 0.37 | 1 | 1 | 0.6% | 0.39 |
| Therapeutic response decreased | 22 | 22 | 2.5% | 0.76 | 23 | 23 | 4.3% | 2.14 | 1 | 1 | 0.6% | 0.39 |
| Infections and infestations | ||||||||||||
| Bronchitis | 51 | 41 | 4.6% | 1.77 | 18 | 17 | 3.2% | 1.67 | 5 | 5 | 3.2% | 1.95 |
| Ear infection | 21 | 14 | 1.6% | 0.73 | 11 | 10 | 1.9% | 1.02 | 4 | 4 | 2.5% | 1.56 |
| Herpes Zoster | 19 | 19 | 2.1% | 0.66 | 14 | 13 | 2.5% | 1.3 | 1 | 1 | 0.6% | 0.39 |
| Influenza | 36 | 29 | 3.3% | 1.25 | 13 | 10 | 2.1% | 1.21 | 0 | 0 | 0 | 0 |
| Pneumonia | 47 | 41 | 4.6% | 1.63 | 13 | 11 | 2.1% | 1.21 | 2 | 2 | 1.3% | 0.78 |
| Sinusitis | 53 | 31 | 3.5% | 1.84 | 14 | 13 | 2.5% | 1.3 | 8 | 6 | 3.8% | 3.12 |
| Upper respiratory tract infection | 72 | 49 | 5.5% | 2.49 | 57 | 45 | 8.5% | 5.29 | 3 | 3 | 1.9% | 1.17 |
| Urinary tract infection | 51 | 32 | 3.6% | 1.77 | 32 | 23 | 4.3% | 2.97 | 6 | 6 | 3.8% | 2.34 |
| Injury, poisoning and procedural complications | 178 | 108 | 12.1% | 6.17 | 56 | 36 | 6.8% | 5.2 | 17 | 11 | 7.0% | 6.62 |
| Fall | 24 | 21 | 2.4% | 0.83 | 9 | 9 | 1.7% | 0.84 | 9 | 4 | 2.5% | 3.51 |
| Infusion-related reaction | 53 | 37 | 4.2% | 1.84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 486 | 152 | 17.1% | 16.8 | 130 | 84 | 15.8% | 12.1 | 17 | 11 | 7.0% | 6.62 |
| Arthralgia | 150 | 60 | 6.7% | 5.20 | 24 | 19 | 3.6% | 2.23 | 5 | 5 | 3.2% | 1.95 |
| Back pain | 30 | 26 | 2.9% | 1.04 | 7 | 6 | 1.1% | 0.65 | 0 | 0 | 0 | 0 |
| Pain in extremity | 65 | 30 | 3.4% | 2.25 | 4 | 4 | 0.8% | 0.37 | 2 | 2 | 1.3% | 0.78 |
| Osteoarthritis | 26 | 18 | 2.0% | 0.90 | 17 | 14 | 2.6% | 1.58 | 0 | 0 | 0 | 0 |
| Rheumatoid arthritis | 57 | 37 | 4.2% | 1.97 | 18 | 16 | 3.0% | 1.67 | 3 | 3 | 1.9% | 1.17 |
| Nervous system disorders | 166 | 107 | 12.0% | 5.75 | 64 | 48 | 9.1% | 5.94 | 8 | 6 | 3.8% | 3.12 |
| Dizziness | 29 | 23 | 2.6% | 1.00 | 5 | 5 | 0.9% | 0.46 | 1 | 1 | 0.6% | 0.39 |
| Headache | 61 | 44 | 4.9% | 2.11 | 10 | 11 | 1.9% | 1.02 | 1 | 1 | 0.6% | 0.39 |
| Respiratory, thoracic and mediastinal disorders | 226 | 131 | 14.7% | 7.83 | 73 | 44 | 8.3% | 6.78 | 15 | 10 | 6.4% | 5.84 |
| Cough | 40 | 28 | 3.1% | 1.39 | 21 | 16 | 3.0% | 1.95 | 3 | 3 | 1.9% | 1.17 |
| Skin and subcutaneous tissue disorders | 260 | 160 | 18.0% | 9.01 | 83 | 57 | 10.8% | 7.71 | 14 | 11 | 7.0% | 5.45 |
| Pruritus | 35 | 32 | 3.6% | 1.21 | 2 | 2 | 0.4% | 0.19 | 1 | 1 | 0.6% | 0.39 |
| Psoriasis | 10 | 9 | 1.0% | 0.35 | 16 | 11 | 2.1% | 1.49 | 1 | 1 | 0.6% | 0.39 |
| Rash | 39 | 32 | 3.6% | 1.35 | 15 | 15 | 2.8% | 1.39 | 2 | 1 | 0.6% | 0.39 |
| Vascular disorders | 90 | 63 | 7.1% | 3.12 | 14 | 14 | 2.6% | 1.3 | 1 | 1 | 0.6% | 0.39 |
| Hypertension | 27 | 22 | 2.5% | 0.94 | 5 | 5 | 0.9% | 0.46 | 0 | 0 | 0 | 0 |