{"id":118890,"date":"2026-04-23T16:21:09","date_gmt":"2026-04-23T16:21:09","guid":{"rendered":"https:\/\/www.proceadecrc03study.com\/?page_id=118890"},"modified":"2026-04-23T19:50:54","modified_gmt":"2026-04-23T19:50:54","slug":"assessments","status":"publish","type":"page","link":"https:\/\/www.proceadecrc03study.com\/soa\/follow-up\/assessments\/","title":{"rendered":"\u2014 \u2014 FU Assessments"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;212522&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;206826&#8243;][vc_button button_color=&#8221;color-wayh&#8221; size=&#8221;btn-link&#8221; link=&#8221;url:%2Fsoa%2Ffollow-up%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;855349&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-wayh&#8221; uncode_shortcode_id=&#8221;612262&#8243; text_color_type=&#8221;uncode-palette&#8221;]Follow-up Phase[\/vc_custom_heading][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;213699&#8243;]Scroll to the follow-up visit below to see the assessments and procedures.[\/vc_column_text][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;184842&#8243; back_color_type=&#8221;uncode-solid&#8221; row_name=&#8221;1&#8243; back_color_solid=&#8221;#f1fbff&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-wayh&#8221; size=&#8221;btn-link&#8221; link=&#8221;url:%2Fsoa%2Ffollow-up%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;135872&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-wayh&#8221; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;186963&#8243; text_color_type=&#8221;uncode-palette&#8221; subheading=&#8221;Visit Window: 30 days after last dose (\u00b13 days)&#8221;]Safety Follow-up[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;560074&#8243; title=&#8221;Pregnancy test (POCBP only)&#8221;]Urine or serum allowed (see Protocol Section 8.2.4).[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;156643&#8243; title=&#8221;Hematology and biochemistry&#8221;]See Protocol Section 8.2.4 and Appendix 5.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;553192&#8243; title=&#8221;ECOG performance status&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;457507&#8243; title=&#8221;Vital signs&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;189089&#8243; title=&#8221;12-lead ECG&#8221;]See Protocol Section 8.2.3.[\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;205873&#8243; title=&#8221;Subsequent anticancer therapies&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;149057&#8243; title=&#8221;AE and SAE review&#8221;]From the time of signing ICF to Safety Follow-up Visit.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;139572&#8243; title=&#8221;Concomitant medication and procedures review&#8221;]From the time of signing ICF to Safety Follow-up Visit.[\/vc_icon][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;123516&#8243; row_name=&#8221;2&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-wayh&#8221; size=&#8221;btn-link&#8221; link=&#8221;url:%2Fsoa%2Ffollow-up%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;495107&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-wayh&#8221; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;122300&#8243; text_color_type=&#8221;uncode-palette&#8221; subheading=&#8221;Visit Window: Every 90 days after Safety Follow-up (\u00b114 days)&#8221;]Survival Follow-up[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;205873&#8243; title=&#8221;Subsequent anticancer therapies&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;713517&#8243; title=&#8221;Survival Follow-up every 90 days&#8221;]Will be done (e.g. by phone) until death or EOS, whichever comes first. See also Protocol Section 4.4.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;658706&#8243; title=&#8221;CT Scan \/ MRI&#8221;]Subsequent scheduled tumor assessments will be done every 12 weeks (\u00b1 7 days) until disease progression according to RECIST V1.1, death, lost to follow-up, withdrawal of consent, or End of Study, whichever comes first, regardless of study intervention delays, discontinuation, or subsequent anticancer therapies.[\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;212522&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":118889,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-118890","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/pages\/118890","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/comments?post=118890"}],"version-history":[{"count":0,"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/pages\/118890\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/pages\/118889"}],"wp:attachment":[{"href":"https:\/\/www.proceadecrc03study.com\/wp-json\/wp\/v2\/media?parent=118890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}