Safety assessment
death
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, ADVERSE EVENT
Safety and tolerability assessments of ZSP1601 were undertaken for each patient throughout the study. Adverse events (AEs) need to be collected during the study. The Common Terminology Criteria for Adverse Events (CTCAE 5.0) was used to grade the severity of the AEs, according to five categories of grades: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life threatening), and Grade 5 (death). The AEs identified as severe were reported using the Serious Adverse Event Report Form. The attribution of all AEs was determined by the investigators. Based on CTCAE 5.0, dose escalation will be halted if any of the following conditions are met: (1) More than half of the subjects experience grade 2 or higher drug-related adverse events, (2) More than a quarter of the subjects experience grade 3–4 drug-related adverse events, or (3) a drug-related serious adverse event (SAE) occurs. The next highest dose level was initiated after a 14-day safety observation of the previous by principal investigator and sponsor.