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Marks from pdftotext -bbox binned to header column centres, checked visually against renders of every page. Abbreviation block yields no annotations.", "model": "claude-opus-5-5" }, "table_metadata": { "table_id": "table-004", "table_number": 4, "table_type": "track", "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_purpose": "Early termination visit (ETV), unscheduled visit (V997) and post-treatment follow-up visits (V801, V802)", "page_start": 43, "page_end": 46, "track_label": "Early Termination / Unscheduled / Post-Treatment", "column_count": 4, "row_count": 44, "header_row_count": 5, "activity_row_count": 39, "notes": "Independent schedule with its own visit columns (ETV, V997, V801, V802) referenced by Tables 1-3 for early termination and unscheduled visits; typed main_soa (alternative: track for the follow-up phase, see review item D11). L=1; data columns positions 2-5. Page 46 contributes only the Randomization and Dosing header and a mark-free Dosing row whose comment states no dosing in this period." }, "schedule_properties": [ { "property_id": "prop-001", "table_id": "table-004", "row_position": 1, "property_name": "Visit number", "property_name_source": { "row_position": 1, "column_position": 1, "cell_value": "Visit number" }, "property_type": "visit", "property_comment": "Visit identifiers: ETV (early termination visit), V997 (unscheduled visit), V801 and V802 (post-treatment follow-up visits); property_type visit.", "hierarchical_level": 1, "parent_property_id": null, "child_property_ids": [ "prop-002" ], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-002", "table_id": "table-004", "row_position": 2, "property_name": "Weeks from randomization", "property_name_source": { "row_position": 2, "column_position": 1, "cell_value": "Weeks from randomization" }, "property_type": "week", "property_comment": "Week timing: dash for ETV and V997 (event-driven); V801 at 58 or ETV + 8 weeks after last dose, V802 at 66 or ETV + 16 weeks after last dose; property_type week.", "hierarchical_level": 2, "parent_property_id": "prop-001", "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-003", "table_id": "table-004", "row_position": 3, "property_name": "Study day", "property_name_source": { "row_position": 3, "column_position": 1, "cell_value": "Study day" }, "property_type": "study_day", "property_comment": "Study day row; all cells show a dash (no fixed study day). property_type study_day by label.", "hierarchical_level": null, "parent_property_id": null, "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-004", "table_id": "table-004", "row_position": 4, "property_name": "Visit interval tolerance (days)", "property_name_source": { "row_position": 4, "column_position": 1, "cell_value": "Visit interval tolerance (days)" }, "property_type": "window", "property_comment": "Visit window: dash for ETV and V997, ±7 days for V801 and V802; property_type window.", "hierarchical_level": null, "parent_property_id": null, "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-005", "table_id": "table-004", "row_position": 5, "property_name": "Fasting visit", "property_name_source": { "row_position": 5, "column_position": 1, "cell_value": "Fasting visit" }, "property_type": "visit_attribute", "property_comment": "Shaded header-band row; no visit is marked, and the Comment cell reads 'No fasting in this period'. 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If not performed at ETV, this will not be considered a protocol deviation.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-033", "column_id": "col-002" } ] }, "marker_locations": [ { "table_number": 4, "location_type": "schedule_cell", "row_position": 38, "column_position": 2, "method": "text_match" } ] }, { "annotation_id": "annot-015", "table_id": "table-004", "annotation_marker": "c13", "annotation_type": "footnote", "annotation_text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-034", "column_id": "col-002" } ] }, "marker_locations": [ { "table_number": 4, "location_type": "schedule_cell", "row_position": 39, "column_position": 2, "method": "text_match" } ] }, { "annotation_id": "annot-016", "table_id": "table-004", "annotation_marker": "c14", "annotation_type": "footnote", "annotation_text": "No dosing at ETV, V997, or post-treatment follow-up visits.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-039" ], "cell_references": [] }, "marker_locations": [ { "table_number": 4, "location_type": "activity_name", "row_position": 44, "method": "synthesized" } ] }, { "annotation_id": "annot-017", "table_id": "table-004", "annotation_marker": "c15", "annotation_type": "footnote", "annotation_text": "V997: Vital signs collection is optional.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-007", "column_id": "col-003" } ] }, "marker_locations": [ { "table_number": 4, "location_type": "schedule_cell", "row_position": 12, "column_position": 3, "method": "text_match" } ] }, { "annotation_id": "annot-018", "table_id": "table-004", "annotation_marker": "c16", "annotation_type": "footnote", "annotation_text": "Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-034" ], "cell_references": [] }, "marker_locations": [ { "table_number": 4, "location_type": "activity_name", "row_position": 39, "method": "synthesized" } ] }, { "annotation_id": "annot-019", "table_id": "table-004", "annotation_marker": "c17", "annotation_type": "footnote", "annotation_text": "If not performed at ETV, this will not be considered a protocol deviation.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-034", "column_id": "col-002" } ] }, "marker_locations": [ { "table_number": 4, "location_type": "schedule_cell", "row_position": 39, "column_position": 2, "method": "text_match" } ] } ], "review_items": [ { "id": "D11", "severity": "medium", "location": { "page": 43 }, "call_made": "Table 4 (ETV, unscheduled visit V997 and post-treatment follow-up V801/V802) is typed 'main_soa' as an independent schedule with its own visit columns that applies to all participants.", "alternative": "Type it 'track' (track_label e.g. 'Follow-Up') as a separate study phase timeline.", "report_section": "T4.1" }, { "id": "D12", "severity": "medium", "location": { "page": 43, "row_position": 1, "annotation_marker": "t1" }, "call_made": "The title-cell note 'V802 is only for randomized participants who were positive for anti-HBc…' is bound to the V802 cell and 'V997: Additional study procedures…' to the V997 cell of the Visit number row.", "alternative": "Bind both as table-wide notes to the Visit number property row.", "report_section": "T4.5" }, { "id": "D13", "severity": "medium", "location": { "page": 43, "annotation_marker": "c4" }, "call_made": "The Vital signs comment, which ends with 'V997: Vital signs collection is optional.', is kept as one footnote on the Vital signs row (one rule-bounded cell).", "alternative": "Split the V997 sentence into its own note bound to the Vital signs × V997 cell.", "report_section": "T4.5" } ] }