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Table 6 Treatment-Emergent Adverse Events that Occurred in ≥ 3% of Patients (mITT Population), Number of Patients (%)

From: Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia

Body System Tigecycline Levofloxacin Total Fisher Exact
Adverse Event (n = 216) N (%) (n = 212) n (%) (N = 428) N (%) P-Value
Any adverse event 135 62.5 100 47.2 235 54.9 0.002*
Body as a whole 29 13.4 26 12.3 55 12.9 0.774
   Headache 10 4.6 4 1.9 14 3.3 0.173
Digestive system 82 38.0 44 20.8 126 29.4 <0.001*
   Diarrhoea 16 7.4 17 8.0 33 7.7 0.858
   Nausea 58 26.9 18 8.5 76 17.8 <0.001*
   Vomiting 36 16.7 14 6.6 50 11.7 0.001*
Haemic and lymphatic system 31 14.4 11 5.2 42 9.8 0.002*
   Leukocytosis 15 6.9 2 0.9 17 4.0 0.002*
   Thrombocythaemia 11 5.1 4 1.9 15 3.5 0.112
Metabolic and nutritional 20 9.3 26 12.3 46 10.7 0.351
   ALT/SGPT increased 4 1.9 9 4.2 13 3.0 0.169
   AST/SGOT increased 4 1.9 7 3.3 11 2.6 0.378
   Hypokalaemia 1 0.5 8 3.8 9 2.1 0.019*
  1. Abbreviation: ALT/SGPT = alanine aminotransferase (serum glutamic pyruvic transaminase); AST/SGOT = aspartate aminotransferase/serum glutamic oxaloacaetic transaminase.
  2. Some subjects had more than 1 treatment-emergent adverse event.
  3. *Significant between-group difference at 0.05 level.