Table 5 Serious adverse events
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% | |