| IFX (N = 890) | GLM (N = 530) | GLM-IV (N = 157) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Exposure (Total, Mean pt.yrs) | 2714, 3.0 | 1077, 2.0 | 257, 1.6 | |||||||||
SOC | 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 |
Total | 3017 | 547 | 61.5% | 105 | 1212 | 357 | 67.4% | 113 | 212 | 93 | 59.2% | 82.6 |
Cardiac disorders | 45 | 39 | 4.4% | 1.56 | 20 | 16 | 3.0% | 1.86 | 1 | 1 | 0.6% | 0.39 |
Eye disorders | 73 | 47 | 5.3% | 2.53 | 25 | 15 | 2.8% | 2.32 | 2 | 2 | 1.3% | 0.78 |
Gastrointestinal disorders | 193 | 112 | 12.6% | 6.69 | 73 | 52 | 9.8% | 6.78 | 12 | 7 | 4.5% | 4.68 |
General disorders and administration site conditions | 297 | 175 | 19.7% | 10.3 | 169 | 148 | 27.9% | 15.7 | 40 | 38 | 24.2% | 15.6 |
Infections and infestations | 689 | 275 | 30.9% | 23.9 | 378 | 173 | 32.6% | 35.1 | 62 | 36 | 22.9% | 24.2 |
Injury, poisoning and procedural complications | 178 | 108 | 12.1% | 6.17 | 56 | 36 | 6.8% | 5.2 | 17 | 11 | 7.0% | 6.62 |
Investigations | 7 | 58 | 6.5% | 2.56 | 13 | 10 | 1.9% | 1.21 | 5 | 4 | 2.5% | 1.95 |
Musculoskeletal and connective tissue disorders | 486 | 152 | 17.1% | 16.8 | 130 | 84 | 15.8% | 12.1 | 17 | 11 | 7.0% | 6.62 |
Neoplasms benign, malignant and unspecified | 54 | 46 | 5.2% | 1.87 | 26 | 23 | 4.3% | 2.41 | 1 | 1 | 0.6% | 0.39 |
Nervous system disorders | 166 | 107 | 12.0% | 5.75 | 64 | 48 | 9.1% | 5.94 | 8 | 6 | 3.8% | 3.12 |
Psychiatric disorders | 19 | 17 | 1.9% | 0.66 | 10 | 10 | 1.9% | 0.93 | 2 | 2 | 1.3% | 0.78 |
Respiratory, thoracic and mediastinal disorders | 226 | 131 | 14.7% | 7.83 | 73 | 44 | 8.3% | 6.78 | 15 | 10 | 6.4% | 5.84 |
Skin and subcutaneous tissue disorders | 260 | 160 | 18.0% | 9.01 | 83 | 57 | 10.8% | 7.71 | 14 | 11 | 7.0% | 5.45 |
Surgical and medical procedures | 42 | 38 | 4.3% | 1.45 | 10 | 9 | 1.7% | 0.93 | 1 | 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 |