Table 3 Reported AEs in corticosteroid studies
Study | Described safety outcomes in the manuscript | Definitions | Events per total patients analyzed | Events per total patients analyzed in intervention arm |
|---|---|---|---|---|
6 | Superinfection | Medical Dictionary for Regulatory Activities classification A new infection ≥ 48 h after randomization up to day 180 | 0.30 | 0.31 |
Bleeding | Intracranial hemorrhage, any bleeding requiring surgery or at least 2 red blood cell transfusions up to day 28 | 0.56 | 0.53 | |
Gastroduodenal bleeding | None provided | 0.07 | 0.06 | |
Hyperglycemia | Glucose levels ≥ 150 mg/dL, up to day 7 | 0.86 | 0.89 | |
Neurologic sequelae | Muscular Disability Rating Scale (> 3), up to day 180 | 0.16 | 0.18 | |
7 | Incidence of new onset bacteremia or fungemia | Between 2 and 14 days, but no definition provided | 0.143 | 0.143 |
Blood transfusion | In the ICU, ut no definition provided | 0.37 | 0.39 | |
Hyperglycemia | None provided | < 0.01 | < 0.01 | |
Hypernatremia | None provided | < 0.01 | < 0.01 | |
Hyperchloremia | None provided | < 0.01 | < 0.01 | |
Hypertension | None provided | < 0.01 | < 0.01 | |
Bleeding | None provided | < 0.01 | < 0.01 | |
Encephalopathy | None provided | < 0.01 | < 0.01 | |
Leukocytosis | None provided | < 0.01 | < 0.01 | |
Myopathy | None provided | < 0.01 | < 0.01 | |
Septic arthritis | None provided | < 0.01 | < 0.01 | |
Ischemic bowel | None provided | < 0.01 | < 0.01 | |
Abdominal-wound dehiscence | None provided | < 0.01 | < 0.01 | |
Circulatory shock | None provided | < 0.01 | < 0.01 | |
Thrombocytopenia | None provided | < 0.01 | < 0.01 | |
26 | Muscle weakness | Severity of muscle weakness until ICU discharge Evaluated using the Medical research council scale | 0.22 | 0.25 |
Weaning failure | Weaning failure is defined as re-intubation within 24 h after extubation OR the need of continuous non-invasive mechanical ventilation with pressure support for more than 48 h after extubation Up to day 28 | 0.09 | 0.09 | |
Secondary infection | Secondary infection is defined as a microbiologically proven new infection which occurs more than 48 h after application of first study medication, with or without adaptation of the antibiotic regime, OR clinical evidence of a new source of infection with or without microbiological verification Up to day 28 | 0.19 | 0.22 | |
Gastrointestinal bleeding | Acute bleeding which requires treatment with more than 1unit of red blood cells within 24 h. Up to day 28 | 0.01 | 0.02 | |
Hypernatremia | Blood sodium level and frequency of hypernatremia (> 155 mmol/l) up to day 14 | 0.05 | 0.05 | |
Hyperglycemia | Blood glucose level and frequency of hyperglycemia (> 150 mg/dl) up to day 14 | 0.82 | 0.88 | |
33 | Hyperglycemia | None provided | 0. 15 | 0.18 |
Superinfection | Patients tested positive for a nosocomial infection of any source. | 0.01 | 0.02 | |
Gastrointestinal bleeding | None provided | 0.01 | 0 | |
Delirium | None provided | 0.01 | 0.02 | |
Acute kidney injury | None provided | 0. 13 | 0. 13 | |
Acute hepatic failure. | None provided | 0.01 | 0.02 |