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Table 5 Serious adverse events

From: Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers

Motive for seriousness Events N %*
Caused death Acute myocardial infarct 5  
Sudden cardiac death 2  
Acute pulmonary edema 2  
Ventricular fibrillation 1  
Uncompensated heart insufficiency 1  
Ischemic stroke 1  
Acute respiratory failure 1  
Acute gastroenterocolitis 1  
Diabetic ketoacidosis-septic shock 1  
  Subtotal 15 0.8%
Endangered life Acute pulmonary edema 2  
Loss of consciousness 2  
Local infection 1  
Glottic spasm 1  
Faintness 1  
  Subtotal 7 0.4%
Prolonged hospitalization Local infection 4 0.2%
Produced disability Local infection 5 0.3%
TOTAL 31 1.7%
  1. *Percent calculated from 1851 treatment cycles.