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 |