DESCRIPTION OF STUDY PARAMETERS Sample Clauses

DESCRIPTION OF STUDY PARAMETERS. Evaluation of NI-0501 tolerability and safety will be based on the following parameters: • Adverse events (AEs), with special attention being paid to the occurrence of infections • Laboratory parameters: - CBC and hemoglobin - coagulation tests (aPTT, PT, d-Dimers and fibrinogen) - inflammatory markers such as CRP and ferritin, - biochemistry: glucose, triglycerides and liver enzymes (AST, ALT, ALP, γGT, LDH, total bilirubin), albumin, creatinine and urea • ▇▇▇▇▇ ▇▇▇▇▇: body temperature, heart and respiratory rate, blood pressure • Physical examination and changes over time (see Section 7) • Immunogenicity: development of anti-NI-0501 antibodies