Table 5.
Adverse Events by Study Group and Severity Grade
| Variable | Study Group |
Total | ||
|---|---|---|---|---|
| Control (n = 25) | tPA Bolus (n = 19) | tPA Drip (n = 6) | ||
| Severity grade 5 | ||||
| Arrest | 2 | 0 | 0 | 2 |
| Liver failure | 0 | 0 | 1 | 1 |
| Renal failure | 0 | 0 | 1 | 1 |
| Worsening of lung function | 4 | 3 | 1 | 8 |
| Total no. of events | 6 | 3 | 3 | 12 |
| No. of participants | 6 | 3 | 1 | 10 |
| % of participants | 24.0 | 12.0 | 4.0 | 40.0 |
| Severity grade 4 | ||||
| Cardiac arrhythmia | 2 | 0 | 0 | 2 |
| Failed extubation | 0 | 1 | 0 | 1 |
| Hyperkalemia | 1 | 0 | 0 | 1 |
| Hypotension | 2 | 1 | 0 | 3 |
| Liver failure | 1 | 0 | 0 | 1 |
| Multiple organ failure | 0 | 0 | 1 | 1 |
| Peritonitis | 1 | 0 | 0 | 1 |
| Pneumonia | 3 | 0 | 0 | 3 |
| Septic shock | 1 | 0 | 0 | 1 |
| Worsening of lung function | 1 | 0 | 1 | 2 |
| Total no. of events | 12 | 2 | 2 | 16 |
| No. of participants | 5 | 2 | 1 | 8 |
| % of participants | 20.0 | 8.0 | 4.0 | 32.0 |
| Severity grade 3 | ||||
| Candidiasis | 0 | 1 | 0 | 1 |
| Cardiac arrhythmia | 1 | 0 | 0 | 1 |
| Delirium | 0 | 1 | 0 | 1 |
| Deep venous thrombosis | 1 | 0 | 0 | 1 |
| Hypervolemia | 0 | 1 | 0 | 1 |
| Hypotension | 0 | 1 | 0 | 1 |
| Ileus | 0 | 1 | 0 | 1 |
| Pulmonary embolism | 1 | 1 | 0 | 2 |
| Pneumonia | 1 | 2 | 0 | 3 |
| Renal failure | 4 | 0 | 0 | 4 |
| Septic shock | 1 | 0 | 0 | 1 |
| Urinary tract infection | 1 | 1 | 0 | 2 |
| Worsening of lung function | 2 | 0 | 0 | 2 |
| Total no. of events | 12 | 9 | 0 | 21 |
| No. of participants | 8 | 6 | 0 | 14 |
| % of participants | 32.0 | 24.0 | 0 | 56.0 |
| Severity grade 2 | ||||
| Acidosis (respiratory) | 1 | 0 | 0 | 1 |
| Alkalosis, metabolic or respiratory | 1 | 0 | 0 | 1 |
| Aspiration | 1 | 1 | 0 | 2 |
| Bacteremia | 2 | 0 | 1 | 3 |
| Bleeding abdominal | 1 | 0 | 0 | 1 |
| Bleeding hemoptysis | 0 | 1 | 0 | 1 |
| Bleeding rectal tear | 1 | 0 | 0 | 1 |
| Bleeding urinary | 0 | 1 | 0 | 1 |
| Candidiasis | 1 | 0 | 0 | 1 |
| Cardiac arrhythmia | 1 | 2 | 0 | 3 |
| Delirium | 2 | 1 | 0 | 3 |
| Diarrhea | 1 | 0 | 0 | 1 |
| Deep venous thrombosis | 3 | 1 | 0 | 4 |
| EBV | 1 | 0 | 0 | 1 |
| Failure to wean off ventilation | 0 | 1 | 0 | 1 |
| Fracture | 1 | 0 | 0 | 1 |
| HSV | 1 | 0 | 0 | 1 |
| Hyperfibrinogenemia | 1 | 0 | 0 | 1 |
| Hyperglycemia | 0 | 0 | 1 | 1 |
| Hyperkalemia | 0 | 1 | 0 | 1 |
| Hypervolemia | 1 | 0 | 1 | 2 |
| Hypotension | 2 | 1 | 0 | 3 |
| Myopathy | 2 | 1 | 0 | 3 |
| Pleural effusion | 0 | 1 | 1 | 2 |
| Pneumonia | 4 | 2 | 0 | 6 |
| Pneumothorax | 1 | 0 | 0 | 1 |
| Renal failure | 0 | 2 | 1 | 3 |
| Sepsis | 0 | 1 | 0 | 1 |
| Thrombosis arterial | 1 | 0 | 0 | 1 |
| Tongue edema | 0 | 0 | 1 | 1 |
| Urinary retention | 1 | 0 | 0 | 1 |
| Urinary tract infection | 1 | 0 | 0 | 1 |
| Worsening of lung function | 2 | 0 | 0 | 2 |
| Total no. of events | 34 | 17 | 6 | 57 |
| No. of participants | 14 | 6 | 3 | 23 |
| % of participants | 56.0 | 24.0 | 12.0 | 92.0 |
| Severity grade 1 | ||||
| Agitation | 0 | 1 | 0 | 1 |
| Alkalosis, metabolic | 0 | 2 | 0 | 2 |
| Anemia | 5 | 4 | 0 | 9 |
| Aspiration | 2 | 1 | 0 | 3 |
| Bacteremia | 1 | 0 | 0 | 1 |
| Benzodiazepine or opiate withdrawal | 0 | 1 | 0 | 1 |
| Biliary dilation | 0 | 1 | 0 | 1 |
| Bleeding nasal | 1 | 0 | 0 | 1 |
| Bleeding oral | 2 | 2 | 0 | 4 |
| Bleeding vaginal | 0 | 1 | 0 | 1 |
| Bronchial obstruction | 2 | 0 | 0 | 2 |
| Cardiac arrhythmia | 2 | 3 | 0 | 5 |
| Constipation | 2 | 4 | 0 | 6 |
| Dehydration | 0 | 1 | 0 | 1 |
| Delirium | 4 | 2 | 0 | 6 |
| Diarrhea | 1 | 2 | 0 | 3 |
| DVT | 3 | 0 | 0 | 3 |
| Dysphagia | 0 | 2 | 0 | 2 |
| Dysphonia | 2 | 0 | 0 | 2 |
| Encephalopathy | 2 | 0 | 0 | 2 |
| Eosinophilia | 1 | 1 | 0 | 2 |
| Facial edema | 0 | 0 | 1 | 1 |
| Fall | 0 | 1 | 0 | 1 |
| Fever | 7 | 2 | 1 | 10 |
| Hyperglycemia | 3 | 1 | 0 | 4 |
| Hyperkalemia | 1 | 0 | 0 | 1 |
| Hypernatremia | 2 | 3 | 0 | 5 |
| Hypertension | 2 | 2 | 0 | 4 |
| Hypervolemia | 1 | 0 | 0 | 1 |
| Hypoglycemia | 1 | 0 | 0 | 1 |
| Hypokalemia | 0 | 1 | 0 | 1 |
| Hyponatremia | 0 | 1 | 0 | 1 |
| Hypotension | 5 | 1 | 0 | 6 |
| Hypovolemia | 1 | 0 | 0 | 1 |
| Ileus | 1 | 3 | 0 | 4 |
| Leukocytosis | 2 | 3 | 0 | 5 |
| Myopathy | 4 | 4 | 0 | 8 |
| Paraphimosis | 1 | 0 | 0 | 1 |
| Pleural effusion | 0 | 1 | 0 | 1 |
| Pneumatocele | 0 | 1 | 0 | 1 |
| Pneumonia | 2 | 3 | 1 | 6 |
| Pressure ulcer | 1 | 2 | 0 | 3 |
| Pulmonary hypertension | 2 | 0 | 0 | 2 |
| Rash | 0 | 1 | 0 | 1 |
| Renal failure | 2 | 2 | 0 | 4 |
| Renal tubular acidosis | 1 | 0 | 0 | 1 |
| Sinusitis | 0 | 1 | 0 | 1 |
| Thrombocytosis | 0 | 1 | 0 | 1 |
| Thrombocytosis | 0 | 1 | 0 | 1 |
| Transaminitis | 1 | 1 | 0 | 2 |
| Urinary retention | 0 | 2 | 0 | 2 |
| Urinary tract infection | 0 | 2 | 0 | 2 |
| Vomit | 0 | 2 | 0 | 2 |
| Worsening of lung function | 3 | 0 | 0 | 3 |
| Total no. of events | 73 | 70 | 3 | 146 |
| No. of participants | 11 | 11 | 2 | 24 |
| % of participants | 44.0 | 44.0 | 8.0 | 96.0 |
Severity grade: 1 = mild to 5 = life threatening or fatal; includes death only as a consequence of an adverse event. EBV = Epstein-Barr virus; HPV = herpes simplex virus; tPA = tissue plasminogen activator.