Table 7 Common treatment-emergent adverse events (≥3% in either group)
Body System Adverse Event | Tigecycline (N = 97) | Imipenem/cilastatin (N = 102) | Pvaluea |
|---|---|---|---|
Any adverse event | 78 (80.4) | 55 (53.9) | < 0.001 |
Body as a whole | 11 (11.3) | 8 (7.8) | 0.473 |
Chest pain | 3 (3.1) | 1 (1.0) | 0.359 |
Digestive system | 35 (36.1) | 16 (15.7) | 0.001 |
Abdominal distension | 7 (7.2) | 2 (2.0) | 0.094 |
Diarrhea | 5 (5.2) | 9 (8.8) | 0.409 |
Nausea | 21 (21.6) | 4 (3.9) | < 0.001 |
Vomiting | 12 (12.4) | 2 (2.0) | 0.005 |
Hemic and lymphatic system | 23 (23.7) | 21 (20.6) | 0.613 |
Anemia | 3 (3.1) | 3 (2.9) | 1.000 |
Coagulation disorder | 4 (4.1) | 0 (0) | 0.055 |
Monocytosis | 1 (1.0) | 6 (5.9) | 0.119 |
Prothrombin time prolonged | 1 (1.0) | 4 (3.9) | 0.369 |
Thrombocythemia | 6 (6.2) | 6 (5.9) | 1.000 |
Thrombocytopenia | 5 (5.2) | 1 (1.0) | 0.111 |
Metabolic and nutritional | 37 (38.1) | 35 (34.3) | 0.658 |
ALT/SGPT increased | 3 (3.1) | 5 (4.9) | 0.722 |
AST/SGOT increased | 6 (6.2) | 7 (6.9) | 1.000 |
Amylase increased | 8 (8.2) | 9 (8.8) | 1.000 |
Bilirubinemia | 21 (21.6) | 12 (11.8) | 0.085 |
Healing abnormal | 7 (7.2) | 6 (5.9) | 0.779 |
Hyperglycemia | 1 (1.0) | 4 (3.9) | 0.369 |
Hypocalcemia | 6 (6.2) | 5 (4.9) | 0.763 |
Hypokalemia | 1 (1.) | 4 (3.9) | 0.369 |
Hyponatremia | 3 (3.1) | 1 (1.0) | 0.359 |
Hypophosphatemia | 5 (5.2) | 5 (4.9) | 1.000 |
Hypoproteinemia | 10 (10.3) | 11 (10.8) | 1.000 |
Lipase increased | 3 (3.1) | 0 (0) | 0.114 |
Respiratory system | 3 (3.1) | 3 (2.9) | 1.000 |
Cough increased | 3 (3.1) | 1 (1.0) | 0.359 |
Skin and appendages | 1 (1.0) | 4 (3.9) | 0.369 |
Rash | 1 (1.0) | 4 (3.9) | 0.369 |
Adverse event associated with miscellaneous factors | 4 (4.1) | 6 (5.9) | 0.748 |
Local reaction to procedure | 4 (4.1) | 6 (5.9) | 0.748 |