Organon Heist BV

Describe the number and percentage of participants who experienced one or more adverse events, serious adverse events, or adverse reactions among participants who actually used NucoFy injection and/or enteric-coated tablets in China

Primary purpose: To evaluate the effectiveness of letermovir in preventing clinically significant CMV infection, as assessed by the proportion of subjects who develop clinically significant CMV infection by week 24 (approximately 6 months) after transplantation. Secondary purpose: · Evaluate the safety and tolerability of treatment with letermovir based on the proportion of subjects who develop AEs. · To evaluate the effectiveness of letermovir in preventing clinically significant CMV infection, as assessed by the proportion of subjects who develop clinically significant CMV infection by week 14 (approximately 100 days) after transplantation. · Evaluate the effectiveness of letermovir in preventing clinically significant CMV infection by: · As of week 14 after transplantation (approximately 100 days) and week 24 after transplantation (approximately 6 months), for patients with documented Proportion of subjects with CMV viremia initiating PET therapy. · Proportion of subjects who develop CMV disease by week 14 (approximately 100 days) after transplantation and week 24 (approximately 6 months) after transplantation. · The proportion of subjects who died from any cause by week 14 after transplantation (approximately 100 days) and week 24 after transplantation (approximately 6 months).

This study aims to evaluate the pharmacokinetic characteristics, safety, and tolerability of POS intravenous infusion (300 mg, administered Q12hr on day 1 and then QD) in Chinese subjects at high risk of invasive fungal infections to support its registration in China.