{"id":71,"date":"2023-03-24T12:45:42","date_gmt":"2023-03-24T12:45:42","guid":{"rendered":"https:\/\/www.merckconnect.com\/prevymis\/?page_id=71"},"modified":"2026-03-30T09:46:01","modified_gmt":"2026-03-30T09:46:01","slug":"hsct-adverse-reactions","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/prevymis\/hsct-adverse-reactions\/","title":{"rendered":"Adverse events"},"content":{"rendered":"\n\n
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Adverse events (AE) in hematopoietic stem cell transplantation (HSCT) patients<\/strong><\/h1><\/div>\n\n\n\n
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Safety profile through Week 14 (~100 days) post-HSCT in adults<\/a><\/p>\n\n\n\n

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Safety profile from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adults<\/a><\/p>\n\n\n\n

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Safety profile in pediatric R+ recipients of an allogeneic HSCT<\/a><\/p>\n\n\n\n

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Safety profile through Week 14 (~100 days) post-HSCT in adults<\/strong><\/h2><\/div>\n\n\n\n
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Cardiac AEs<\/h2><\/div>\n\n\n\n

The cardiac AE rate was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%). The most common cardiac AEs were tachycardia (reported in 4% of PREVYMIS subjects and in 2% of placebo subjects) and atrial fibrillation (reported in 3% of PREVYMIS subjects and in 1% of placebo subjects). Among those subjects who experienced 1 or more cardiac AEs, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.<\/p>\n\n\n\n

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All grade AEs reported in \u226510% of patients treated with PREVYMIS at a frequency at least 2% greater than placebo<\/h3><\/div>\n\n\n\n
AEs<\/strong><\/td>PREVYMIS<\/strong>
(N=373)<\/td>		Placebo<\/strong>
(n=192)<\/td><\/tr>
Nausea<\/strong><\/td>27%<\/strong><\/td>23%<\/strong><\/td><\/tr>
Diarrhea<\/strong><\/td>26%<\/strong><\/td>24%<\/strong><\/td><\/tr>
Vomiting<\/strong><\/td>19%<\/strong><\/td>14%<\/strong><\/td><\/tr>
Peripheral edema<\/strong><\/td>14%<\/strong><\/td>9%<\/strong><\/td><\/tr>
Cough<\/strong><\/td>14%<\/strong><\/td>10%<\/strong><\/td><\/tr>
Headache<\/strong><\/td>14%<\/strong><\/td>9%<\/strong><\/td><\/tr>
Fatigue<\/strong><\/td>13%<\/strong><\/td>11%<\/strong><\/td><\/tr>
Abdominal pain<\/strong><\/td>12%<\/strong><\/td>9%<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug-related renal and hepatic AEs1<\/sup><\/h3><\/div>\n\n\n\n
AEs<\/strong><\/td>PREVYMIS<\/strong>
(N=373)<\/td>		Placebo<\/strong>
(n=192)<\/td><\/tr>
Renal and urinary disorders<\/strong><\/td>1%<\/strong><\/td>1%<\/strong><\/td><\/tr>
Hepatobiliary disorders<\/strong><\/td>0%<\/strong><\/td>1%<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Rates of discontinuation due to AEs were comparable between PREVYMIS and placebo (13% vs 12%, respectively).<\/p>\n\n\n\n

The median time to engraftment (defined as absolute neutrophil count \u2265 500\/mm3<\/sup> on 3 consecutive days after transplantation) was 19 days in the PREVYMIS group and 18 days in the placebo group.<\/p>\n\n\n\n

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Safety profile from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adults<\/strong><\/h2><\/div>\n\n\n\n
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