Table 3 Serious treatment-emergent adverse events (sTEAEs)
sTEAE, n (%) | Clarithromycin (n = 55) | Placebo (n = 55) | P value |
|---|---|---|---|
At least one sTEAE | 50 (90.9) | 50 (90.9) | 1.000 |
 Infections and infestations | 31 (56.4) | 33 (60.0) | 0.847 |
 Acute kidney injury | 7 (12.7) | 1 (1.8) | 0.060 |
 Disseminated intravascular coagulation | 1 (1.8) | 0 (0.0) | 1.00 |
 Arterial ischemia | 7 (12.7) | 5 (9.1) | 0.761 |
 Cardiac disorders | 7 (12.7) | 5 (9.1) | 0.776 |
  Non-ST elevation myocardial infarct | 2 (3.6) | 1 (1.8) | 0.999 |
  Ventricular tachycardia | 2 (3.6) | 2 (3.6) | 1.00 |
  Pulmonary edema | 3 (5.5) | 2 (3.6) | 1.00 |
 Vascular disorders | 8 (14.5) | 6 (10.9) | 1.00 |
  Arterial ischemia | 7 (12.7) | 5 (9.1) | 0.761 |
  Venous thromboembolism | 0 (0.0) | 1 (1.8) | 1.00 |
  Hemoptysis | 1 (1.8) | 0 (0.0) | 1.00 |
 Hemorrhagic complications | 3 (5.5) | 0 (0.0) | 0.243 |
  Surgical site bleeding with hemorrhagic shock | 2 (3.6) | 0 (0.0) | 0.495 |
 Μetabolic and nutrition disorders | 2 (3.6) | 0 (0.0) | 0.495 |
  Myxedema coma | 1 (1.8) | 0 (0.0) | 1.00 |
  Hypoglycemia | 1 (1.8) | 0 (0.0) | 1.00 |
 Thoracic, pulmonary or mediastinal disorders | 3 (5.5) | 2 (3.6) | 1.00 |
  Airway obstruction (tracheotomy plugs) | 3 (5.5) | 2 (3.6) | 1.00 |
  Pneumothorax | 1 (1.8) | 1 (1.8) | 1.00 |
 Neurological disorders | 1 (1.8) | 3 (5.5) | 0.618 |
  Brain edema | 0 (0.0) | 1 (1.8) | 1.00 |
  Hypoxic encephalopathy | 0 (0.0) | 1 (1.8) | 1.00 |
  Seizures | 1 (1.8) | 1 (1.8) | 1.00 |
 Surgery complications | 4 (7.3) | 1 (1.8) | 0.363 |
  Retinal fissure detachment | 0 (0.0) | 1 (1.8) | 1.00 |
  Nephrostomy | 1 (1.8) | 0 (0.0) | 1.00 |
  Intra-abdominal retention of surgical compress | 1 (1.8) | 0 (0.0) | 1.00 |
  Ileal perforation | 1 (1.8) | 0 (0.0) | 1.00 |
  Surgical wound dehiscence | 1 (1.8) | 0 (0.0) | 1.00 |
  Mediastinal abscess drainage | 1 (1.8) | 0 (0.0) | 1.00 |