Table 3.
Summary of Serious Adverse Events and Adverse Events by Treatment Group.
| Serious Adverse Event | L-carnitine (n = 16) | Placebo (n = 15) |
|---|---|---|
| Respiratory, thoracic, and mediastinal disorders | ||
| Exacerbation of COPD | 1 | 1 |
| Pneumothorax | 1 | 0 |
| Acute respiratory failure | 1 | 2 |
| Pneumoniaa | 1 | 1 |
| Pulmonary embolus | 1 | 0 |
| Cardiac disorders | ||
| Atrial fibrillation with RVR | 1 | 0 |
| Cardiac arrest with ROSC | 0 | 1 |
| Patent foramen ovale diagnosed | 0 | 1 |
| Endocrine disorders | ||
| Hypoglycemia | 1 | 0 |
| Renal/urinary disorders | ||
| Acute on chronic renal failure | 1 | 0 |
| Acute renal failure | 2 | 1 |
| End-stage renal disease (new dialysis) | 2 | 0 |
| Hematological disorders | ||
| Heparin-induced thrombocytopenia | 1 | 0 |
| Worsening anemia | 1 | 1 |
| Worsening thrombocytopenia | 2 | 0 |
| Disseminated intravascular coagulation | 1 | 1 |
| Deep venous thrombosis | 0 | 1 |
| Gastrointestinal disorders | ||
| Gastrointestinal bleeding | 2 | 0 |
| Diarrhea | 0 | 1 |
| Nausea/vomiting | 0 | 1 |
| Hepatobiliary disorders | ||
| Worsening liver function | 0 | 1 |
| Obstructive jaundice | 0 | 1 |
| Immune system disorders | ||
| Infections and infestationsb | 1 | 5 |
| Neoplasms benign, malignant and unspecified | ||
| Newly diagnosed neoplasm during hospitalization | 0 | 2 |
| Nervous system disorders | ||
| Seizure | 1 | 2 |
| CVA | 1 | 0 |
| Central cord compression | 1 | 0 |
| Critical illness myopathy and/or encephalopathy | 2 | 0 |
| Skin and subcutaneous tissue disorders—abscess | 0 | 1 |
| Electrolyte imbalances | ||
| Hypokalemia | 1 | 1 |
| Hypomagnesemia | 0 | 1 |
| Death | ||
| 28 days | 4 | 9 |
| 3 months | 9 | 10 |
| 6 months | 9 | 12 |
| 12 months | 9 | 12 |
Data presented as absolute numbers. COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; ROSC, return of spontaneous circulation; RVR, rapid ventricular response.
Pneumonia only counted under respiratory disorders but not recounted under new infections.
New infections were as follows: in the L-carnitine–treated group, there was 1 case of sepsis not otherwise specified, of unclear source. In the placebo group, 2 patients had all 5 new infections. One patient had an episode of sepsis from a biliary source. The second patient had a prolonged intensive care unit course complicated by an intra-abdominal abscess, candidemia, multidrug-resistant bacteremia from a urinary source, and later recurrent sepsis from a urinary source. This patient also had H1N1 influenza, which was counted under pneumonia.