English to Russian Medical Medical: Pharmaceuticals

In addition to the SAEs leading to withdrawal listed above for 6 subjects, 1 subject was withdrawn owing to a non-serious AE of fatigue.
No TEAEs of special interest (hypersensitivity-like reactions and remote spread of toxin events) were identified following adjudication.
There were no notable changes in systolic blood pressure, diastolic blood pressure, heart rate, weight, or body mass index during the study.
Overall, the SUSARs had no impact on the benefit-risk profile of this drug and the majority of the other safety data reported in this study were consistent with the known safety profile for this drug.