Type of AE/SAE | n | Per cent | Severity | Reported as SAE? | SAE/AE related to study drug | Stopped study drug? |
---|---|---|---|---|---|---|
Dantrolene | ||||||
Vein irritation/infiltration | 4 | 23.5 | Mild/Moderate | Likely | ||
Neurological deterioration requiring osmotherapy | 2 | 11.8 | Severe | ✓ | Possibly | ✓(both) |
LFT elevation >5× upper limit of normal | 1 | 5.9 | Severe | ✓ | Possibly | ✓ |
Acute respiratory failure | 2 | 11.8 | Severe | ✓ | Doubtful | ✓(one) |
Nausea/vomiting | 3 | 17.7 | Mild | Doubtful | ||
Headache | 2 | 11.8 | Mild | Possibly | ||
UTI | 1 | 5.9 | Moderate | Not related | ||
Non-ST-elevation myocardial infarction | 1 | 5.9 | Moderate | Not related | ||
Constipation leading to nausea/vomiting | 1 | 5.9 | Moderate | Possibly | ||
Placebo | ||||||
Rash | 1 | 20 | Moderate | Doubtful | ||
Neurological deterioration requiring osmotherapy | 1 | 20 | Severe | ✓ | Possibly | ✓ |
Nausea/vomiting | 1 | 20 | Mild | Doubtful | ||
Headache treated with mannitol | 1 | 20 | Severe | ✓ | Possibly | ✓ |
Administration error | 1 | 20 | Severe | ✓ | Not related |
Adverse events (AE) and severe adverse events (SAEs) are listed by study group. Those AE/SAE which were likely or possibly related to study drug infusion are highlighted in grey. SAEs were reported to our local IRB, as well as to the pharmaceutical company per request.
IRB, institutional review board; LFT, liver function test; UTI, urinary tract infection.