{"id":7384,"date":"2026-04-02T06:38:43","date_gmt":"2026-04-02T06:38:43","guid":{"rendered":"https:\/\/www.merckconnect.com\/winrevair\/?page_id=7384"},"modified":"2026-04-02T10:49:05","modified_gmt":"2026-04-02T10:49:05","slug":"nct04896008-adverse-reactions","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/winrevair\/nct04896008-adverse-reactions\/","title":{"rendered":"Zenith Adverse reactions"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-top mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-columns is-not-stacked-on-mobile is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"column-wrapper _0b646ff6-d188-40c4-842c-97202c4d6ad2\"><style>\n\t\t\t\t@media (min-width: 1024px) {\n\t\t\t\t\t.column-wrapper {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 1024px) {\n\t\t\t\t\t#block-0b646ff6-d188-40c4-842c-97202c4d6ad2,\n\t\t\t\t\t._0b646ff6-d188-40c4-842c-97202c4d6ad2 {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.wp-block-columns:not(.is-not-stacked-on-mobile)>.column-wrapper {\n\t\t\t\t\t\tflex-basis: 100% !important;\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 767px) {\n\t\t\t\t\t#block-0b646ff6-d188-40c4-842c-97202c4d6ad2,\n\t\t\t\t\t._0b646ff6-d188-40c4-842c-97202c4d6ad2 {\n\t\t\t\t\t\tflex-basis: 25% !important;display: unset !important;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t<\/style><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:8%\"><link rel='stylesheet' id='vivid360-image-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"wp-block-vivid360-image img-container mb-0 ml-0 mt-0 mr-0\"><figure class=\"wp-block-vivid360-image is-style-default size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"80\" height=\"80\" src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/STELLAR-icon-1.png?w=80\" alt=\"\" class=\"wp-image-7372  style-noshadow   \" style=\"height:80px;width:80px\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"column-wrapper _beed133a-386a-4fed-b8eb-5bae1ab066f8\"><style>\n\t\t\t\t@media (min-width: 1024px) {\n\t\t\t\t\t.column-wrapper {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 1024px) {\n\t\t\t\t\t#block-beed133a-386a-4fed-b8eb-5bae1ab066f8,\n\t\t\t\t\t._beed133a-386a-4fed-b8eb-5bae1ab066f8 {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.wp-block-columns:not(.is-not-stacked-on-mobile)>.column-wrapper {\n\t\t\t\t\t\tflex-basis: 100% !important;\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 767px) {\n\t\t\t\t\t#block-beed133a-386a-4fed-b8eb-5bae1ab066f8,\n\t\t\t\t\t._beed133a-386a-4fed-b8eb-5bae1ab066f8 {\n\t\t\t\t\t\tflex-basis: 75% !important;display: unset !important;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t<\/style><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:92%\"><link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid360-heading\" id=\"a08def799-05ec-40f4-97a5-0c78b28d1c3d\"><h4 class=\"has-primary-color content-width fontWeightBold\" style=\"--desktopFontSize:18px;--tabletFontSize:22px;--mobileFontSize:16px;--desktopLineHeightSize:27px;--tabletLineHeightSize:33px;--mobileLineHeightSize:\" id=\"\"><strong>In ZENITH, a study of adults with PAH (WHO FC III or IV) at high risk of mortality on background therapy:<\/strong><\/h4><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a9624705d-77c1-47a8-8e09-5aa6cbdb6e1d\"><h1 class=\"has-primary-color content-width fontWeightBold\" style=\"--desktopFontSize:30px;--tabletFontSize:22px;--mobileFontSize:22px;--desktopLineHeightSize:45px;--tabletLineHeightSize:33px;--mobileLineHeightSize:\" id=\"\"><strong>Adverse reactions <span class=\"no-wrap-text\">\u226510%<\/span> in patients receiving<\/strong> <strong>WINREVAIR<sup>TM<\/sup> <\/strong><br><strong>(sotatercept-csrk) and at least <span class=\"no-wrap-text\">5%<\/span> more than<\/strong> <strong>placebo in <\/strong><br><strong>ZENITH<\/strong><\/h1><\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--mobile-spacer:16px;--tablet-spacer:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper wp-elements-cb3a9e3c4d057ffb834b08f5a60b5dd0\"><div class=\"_1d51eb72-765d-4517-b73a-5079ba0845b0 \" id=\"\"><p class=\"has-dark-text-color has-text-color has-link-color has-regular-font-size\">The overall incidences of adverse reactions in both arms were higher in the ZENITH trial than in the STELLAR trial.<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper wp-elements-29e10dd19c69304b136a2e42be328a11\"><div class=\"_bacaf133-f905-4c63-8421-f956965141eb \" id=\"\"><p class=\"has-dark-text-color has-text-color has-link-color has-regular-font-size\">The median duration of exposure was longer in the WINREVAIR group (435 days) than in the placebo group (268 days).<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:32px;--mobile-spacer:16px;--tablet-spacer:32px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<figure class=\"wp-block-flexible-table-block-table is-content-justification-center\"><table class=\"has-fixed-layout\" style=\"border-collapse:collapse\"><thead><tr><th style=\"width:40%;border-color:#acacac;color:#3b3b3c;background-color:#ecf1e5;text-align:center;font-size:16px;padding-top:19px;padding-bottom:19px\"><strong>Adverse reaction<\/strong><\/th><th style=\"width:32.5%;border-color:#acacac;color:#3b3b3c;background-color:#f6e3df;text-align:center;font-size:16px\"><strong><span class=\"no-wrap-text\">WINREVAIR<\/span> (n=86)<\/strong><\/th><th style=\"width:27.5%;color:#3b3b3c;border-color:#acacac;background-color:#f1f2f2;text-align:center;font-size:16px\"><strong>Placebo <span class=\"no-wrap-text\">(n=86)<\/span><\/strong><\/th><\/tr><\/thead><tbody><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Infections<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">58 (67.4%)<\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f1f2f2;text-align:center;font-size:16px\">38 (44.2%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Epistaxis<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">39 (45.3%)<\/td><td style=\"border-color:#acacac;background-color:#f1f2f2;color:#3b3b3c;text-align:center;font-size:16px\">8 (9.3%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Diarrhea<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">22 (25.6%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">15 (17.4%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Telangiectasia<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">22 (25.6%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">3 (3.5%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Increased hemoglobin<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">13 (15.1%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">1 (1.2%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Rash<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">9 (10.5%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">4 (4.7%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Erythema<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">9 (10.5%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">3 (3.5%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;border-color:#acacac;font-size:16px;text-align:center\"><strong>Gingival bleeding&nbsp;<\/strong><\/td><td style=\"color:#3b3b3c;border-color:#acacac;background-color:#f6e3df;text-align:center;font-size:16px\">9 (10.5%)<\/td><td style=\"border-color:#acacac;color:#3b3b3c;background-color:#f1f2f2;text-align:center;font-size:16px\">2 (2.3%)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:16px;--tablet-spacer:0px;--mobile-spacer:0px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-image-module-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image-module\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-image-module ratio-50-50 content-above one-col full-page-width\"><div class=\"vivid360-block-image-module__content-wrapper content-align-left\" id=\"contentDiv\"><\/div><figure class=\"vivid360-block-image-module__image-container\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/winrevair-adverse_reactions-diagram-mobile.png?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2-3.png?w=1440\"\/><img decoding=\"async\" width=\"1872\" height=\"173\" data-src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2-3.png\" loading=\"lazy\" src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2-3.png\" alt=\"WINREVAIR Had a Low Rate of Discontinuation Due to Adverse Reactions: 1% on WINREVAIR vs 5% on Placebo\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:32px;--tablet-spacer:16px;--mobile-spacer:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"wp-block-columns mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"abfb3d84f-84e3-4c8c-a597-515ff721966b\"><h6 class=\"has-primary-color has-text-align-left has-error-light-bgr-background-color content-width fontWeightRegular padding-top-bottom10 mt-0 mb-0 padding-left-right15\" style=\"--desktopFontSize:16;--tabletFontSize:16;--mobileFontSize:16;--desktopLineHeightSize:24px;--tabletLineHeightSize:24px;--mobileLineHeightSize:;--tabletAlign:left;--mobileAlign:left\" id=\"\"><strong>Report exposure during pregnancy or lactation to the <span class=\"no-wrap-text\">Merck Sharp &amp; Dohme<\/span>&nbsp;LLC Adverse Event reporting line at <span class=\"no-wrap-text\">1-877-888-4231<\/span><\/strong><\/h6><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;height:32px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-32\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70px\"><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The overall incidences of adverse reactions in both arms were higher in the ZENITH trial than in the STELLAR trial. The median&#8230;<\/p>\n","protected":false},"author":4249,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[],"ga4_page_customer_journey_stage":[],"ga4_page_customer_specialty":[],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[],"ga4_page_product":[],"ga4_page_region":[],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-7384","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Adverse Reactions From Second Phase III Clinical Trial for WINREVAIR\u2122 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