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Supplementary Appendix). Serious adverse events were reported in 35 patients (32%); the most common (>2% incidence) were febrile neutropenia (in 7% of the patients), vomiting (in 6%), nausea (in 4%), diarrhea (in 3%), and dyspnea (in 3%).
Adverse events leading to interruption of treatment occurred in 48 of the 108 patients (44%); the most common reason was neutropenia. Three patients (3%) discontinued treatment because of adverse events; 2 patients discontinued because of drug-related events, and 1 patient discontinued because of hypertension, which was thought by the investigator not to be drug-related. Transient changes in laboratory safety values that occurred during treatment included decreases in blood-cell counts and alterations in biochemical values, which generally recovered by the end of treatment.
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