{ "schema_name": "soa-table-resolved", "schema_version": "1.2", "resolution_metadata": { "resolved_at": "2026-10-03T15:50:56.856375+00:00", "resolver": "soa2usdm.steps.resolve v1.0", "source_extraction": { "schema_name": "soa-table-extraction", "schema_version": "1.0", "extraction_file": "NCT03637764_Table_02_extraction.verified.json", "extraction_status": "ready_for_resolution" }, "validation_results": { "structure_valid": true, "hierarchy_valid": true, "annotations_valid": true, "validation_warnings": [ "Property 'Sample time window Atezolizumab' (type=window) has no hierarchical_level but sits between L4 and L5 — may be a missing level assignment" ], "validation_errors": [], "method_provenance": [ "indentation_level:font_signal: 9" ] }, "resolution_status": "resolved_with_warnings", "ready_for_integration": true, "resolution_notes": "" }, "extraction_metadata": { "extracted_at": "2026-09-27T21:05:00+02:00", "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass", "prompt_version": "3.8.1", "source_document": { "filename": "NCT03637764_soa.pdf", "document_type": "protocol", "document_version": "Amended Clinical Trial Protocol 05, Version number: 1", "document_date": "23-Nov-2020" }, "extraction_status": "ready_for_resolution", "extraction_notes": "Text-layer PDF with vector rule lines. Grid read with pdftotext -bbox, column/row boundaries from rule lines recovered on a 200 dpi render (§1d). One label column (L=1); data columns 2-23. Body rows 9-16 are drawn with vertical rules offset up to ~16 px (200 dpi) from the header rules; body cells assigned to header columns by majority x-overlap. Grey-shaded cells without text carry no entry; '-' is transcribed literally. Abbreviation block on p.23 not extracted (its terms occur only as cell values, never as markers).", "model": "claude-opus-5-5" }, "table_metadata": { "table_id": "table-002", "table_number": 2, "table_type": "subsidiary", "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_purpose": "Per-sample PK and ADA timing (relative to start/end of infusion) for atezolizumab and isatuximab, with IMP infusion timing", "page_start": 22, "page_end": 23, "track_label": null, "column_count": 22, "row_count": 16, "header_row_count": 7, "activity_row_count": 9, "notes": "Typed subsidiary: the main SoA (Table 01, p.21) carries single rows 'PK' and 'ADA' reading 'See Pharmacokinetics and immunogenicity Flow Chart'; this table breaks those into per-sample IDs on a finer, within-day timepoint grid (SOI/EOI/EOI+Xh). Grid on p.22; footnotes f-j and abbreviations continue on p.23 (no body rows there)." }, "schedule_properties": [ { "property_id": "prop-001", "table_id": "table-002", "row_position": 1, "property_name": "Study Phase", "property_name_source": { "row_position": 1, "column_position": 1, "cell_value": "Study Phase" }, "property_type": "epoch", "property_comment": "Study phase band: 'Treatment Phase' spans all cycle columns (2:21), 'Post-treatment' spans EOT and FUP (22:23). Major study phases -> epoch.", "hierarchical_level": 1, "parent_property_id": null, "child_property_ids": [ "prop-002" ], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-002", "table_id": "table-002", "row_position": 2, "property_name": "Cycle", "property_name_source": { "row_position": 2, "column_position": 1, "cell_value": "Cycle" }, "property_type": "cycle", "property_comment": "Treatment cycles: Cycle 1 (2:10), Cycle 2 (11:13), Cycle 3 (14:15), Cycle 4 (16:19), Subsequent Cycles (20:21); EOT (22) and FUP (90±7 days) (23) are cells vertically merged across this row and the Day row, recorded on this row only. Repeating oncology cycles -> cycle.", "hierarchical_level": 2, "parent_property_id": "prop-001", "child_property_ids": [ "prop-003" ], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-003", "table_id": "table-002", "row_position": 3, "property_name": "Day within the Cycle", "property_name_source": { "row_position": 3, "column_position": 1, "cell_value": "Day within the Cycle" }, "property_type": "study_day", "property_comment": "Day within the cycle: D1 (2:8), D15 (9:10) in Cycle 1; D1 for every later cycle. Columns 22-23 are covered by the vertically merged EOT / FUP cells from the Cycle row. Note the source prints the 72h and 168h (SOI of Day 8) columns under the Cycle 1 'D1' span. Day numbers -> study_day.", "hierarchical_level": 3, "parent_property_id": "prop-002", "child_property_ids": [ "prop-004" ], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-004", "table_id": "table-002", "row_position": 4, "property_name": "Sample RNT (h) Ref: SOI Atezolizumab", "property_name_source": { "row_position": 4, "column_position": 1, "cell_value": "Sample RNT (h)\nRef: SOI\nAtezolizumab" }, "property_type": "timepoint", "property_comment": "Atezolizumab relative nominal sampling times (SOI, EOI, EOI +30 min), referenced to atezolizumab start of infusion; '-' where no atezolizumab timepoint applies. Within-visit timing -> timepoint. Drug-specific: governs the atezolizumab PK/ADA rows. Parallel to row 6 (isatuximab scale); stacked levels 4 and 5 follow print order, not a parent-child relation.", "hierarchical_level": 4, "parent_property_id": "prop-003", "child_property_ids": [ "prop-006" ], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-005", "table_id": "table-002", "row_position": 5, "property_name": "Sample time window Atezolizumab", "property_name_source": { "row_position": 5, "column_position": 1, "cell_value": "Sample time\nwindow\nAtezolizumab" }, "property_type": "window", "property_comment": "Allowed sampling windows for the atezolizumab timepoints in row 4 ([-24h, SOI], ±5 min, ±10 min). Window qualifier of row 4; does not by itself distinguish columns -> level null.", "hierarchical_level": null, "parent_property_id": null, "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-006", "table_id": "table-002", "row_position": 6, "property_name": "Sample RNT (h) Ref: SOI Isatuximab", "property_name_source": { "row_position": 6, "column_position": 1, "cell_value": "Sample RNT (h)\nRef: SOI Isatuximab" }, "property_type": "timepoint", "property_comment": "Isatuximab relative nominal sampling times (SOI, EOI, EOI +4h, 72h, 168h (SOI of Day 8), EOI +1h), referenced to isatuximab start of infusion; '-' where no isatuximab timepoint applies. Within-visit timing -> timepoint. Drug-specific: governs the isatuximab PK/ADA rows. Parallel to row 4; this row carries the finest column split of the table.", "hierarchical_level": 5, "parent_property_id": "prop-004", "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] }, { "property_id": "prop-007", "table_id": "table-002", "row_position": 7, "property_name": "Sample time window Isatuximab", "property_name_source": { "row_position": 7, "column_position": 1, "cell_value": "Sample time\nwindow Isatuximab" }, "property_type": "window", "property_comment": "Allowed sampling windows for the isatuximab timepoints in row 6 (±10 min, ±30 min, ±5 h, [-24h, SOI]). Window qualifier of row 6 -> level null.", "hierarchical_level": null, "parent_property_id": null, "child_property_ids": [], "annotation_markers": "", "linked_annotation_ids": [] } ], "schedule_columns": [ { "column_id": "col-002", "table_id": "table-002", "column_position": 2, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-005", "value": "[-24h, SOI]", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-006", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / SOI / [-24h, SOI] / SOI / -", "linked_annotation_ids": [] }, { "column_id": "col-003", "table_id": "table-002", "column_position": 3, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "EOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-005", "value": "±5 min", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-006", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": true, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / EOI / ±5 min / - / -", "linked_annotation_ids": [] }, { "column_id": "col-004", "table_id": "table-002", "column_position": 4, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "EOI +30 min", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-005", "value": "±10 min", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-006", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": true, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / EOI +30 min / ±10 min / - / -", "linked_annotation_ids": [] }, { "column_id": "col-005", "table_id": "table-002", "column_position": 5, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "EOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "±10 min", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / - / - / EOI / ±10 min", "linked_annotation_ids": [] }, { "column_id": "col-006", "table_id": "table-002", "column_position": 6, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "EOI +4h", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "±30 min", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / - / - / EOI +4h / ±30 min", "linked_annotation_ids": [] }, { "column_id": "col-007", "table_id": "table-002", "column_position": 7, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "72h", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "±5 h", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / - / - / 72h / ±5 h", "linked_annotation_ids": [] }, { "column_id": "col-008", "table_id": "table-002", "column_position": 8, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "168h (SOI of Day 8)", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "[-24h, SOI]", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D1 / - / - / 168h (SOI of Day 8) / [-24h, SOI]", "linked_annotation_ids": [] }, { "column_id": "col-009", "table_id": "table-002", "column_position": 9, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D15", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "[-24h, SOI]", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D15 / - / - / SOI / [-24h, SOI]", "linked_annotation_ids": [] }, { "column_id": "col-010", "table_id": "table-002", "column_position": 10, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D15", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "EOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "±10 min", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 1 / D15 / - / - / EOI / ±10 min", "linked_annotation_ids": [] }, { "column_id": "col-011", "table_id": "table-002", "column_position": 11, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 2", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-005", "value": "[-24h, SOI]", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-006", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 2 / D1 / SOI / [-24h, SOI] / SOI / -", "linked_annotation_ids": [] }, { "column_id": "col-012", "table_id": "table-002", "column_position": 12, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 2", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "-", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 2 / D1 / - / - / - / -", "linked_annotation_ids": [] }, { "column_id": "col-013", "table_id": "table-002", "column_position": 13, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 2", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-005", "value": "-", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-006", "value": "EOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "±10 min", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 2 / D1 / - / - / EOI / ±10 min", "linked_annotation_ids": [] }, { 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"" }, { "property_id": "prop-002", "value": "Cycle 4", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-003", "value": "D1", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-004", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-005", "value": "[-24h, SOI]", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-006", "value": "SOI", "is_merged": false, "annotation_markers": "" }, { "property_id": "prop-007", "value": "-", "is_merged": false, "annotation_markers": "" } ], "composite_label": "Treatment Phase / Cycle 4 / D1 / SOI / [-24h, SOI] / SOI / -", "linked_annotation_ids": [] }, { "column_id": "col-017", "table_id": "table-002", "column_position": 17, "is_label_column": false, "column_values": [ { "property_id": "prop-001", "value": "Treatment Phase", "is_merged": true, "annotation_markers": "" }, { "property_id": "prop-002", "value": "Cycle 4", "is_merged": true, "annotation_markers": 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The ADA sample collection for other drug should be done as planned.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-007" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 14 } ] }, { "annotation_id": "annot-006", "table_id": "table-002", "annotation_marker": "f", "annotation_type": "footnote", "annotation_text": "Sample collected just before actual end of infusion of isatuximab.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-006", "column_id": "col-005" }, { "activity_id": "act-006", "column_id": "col-010" }, { "activity_id": "act-006", "column_id": "col-013" }, { "activity_id": "act-006", "column_id": "col-018" } ] }, "marker_locations": [ { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 5 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 10 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 13 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 18 } ] }, { "annotation_id": "annot-007", "table_id": "table-002", "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Isatuximab sample collected strictly before the start of isatuximab infusion (during treatment phase).", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-009" ], "cell_references": [ { "activity_id": "act-006", "column_id": "col-008" }, { "activity_id": "act-006", "column_id": "col-009" }, { "activity_id": "act-006", "column_id": "col-011" }, { "activity_id": "act-006", "column_id": "col-014" }, { "activity_id": "act-006", "column_id": "col-016" }, { "activity_id": "act-006", "column_id": "col-020" } ] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 16 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 8 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 9 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 11 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 14 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 16 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 13, "column_position": 20 } ] }, { "annotation_id": "annot-008", "table_id": "table-002", "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "After FUP 90(±7) days after last isatuximab administration no further ADA will be sampled even if the status is positive or inconclusive.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-009" ], "cell_references": [ { "activity_id": "act-009", "column_id": "col-023" } ] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 16 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 16, "column_position": 23 } ] }, { "annotation_id": "annot-009", "table_id": "table-002", "annotation_marker": "i", "annotation_type": "footnote", "annotation_text": "Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-004", "act-006", "act-007", "act-009" ], "cell_references": [] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 11 }, { "table_number": 2, "location_type": "activity_name", "row_position": 13 }, { "table_number": 2, "location_type": "activity_name", "row_position": 14 }, { "table_number": 2, "location_type": "activity_name", "row_position": 16 } ] }, { "annotation_id": "annot-010", "table_id": "table-002", "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "For subsequent cycles, atezolizumab PK and ADA samples (pre-dose) are to be collected at Cycle 8 Day 1 and Cycle 16 Day 1 only.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-005", "act-008" ], "cell_references": [ { "activity_id": "act-005", "column_id": "col-020" }, { "activity_id": "act-008", "column_id": "col-020" } ] }, "marker_locations": [ { "table_number": 2, "location_type": "activity_name", "row_position": 12 }, { "table_number": 2, "location_type": "activity_name", "row_position": 15 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 12, "column_position": 20 }, { "table_number": 2, "location_type": "schedule_cell", "row_position": 15, "column_position": 20 } ] } ], "review_items": [ { "id": "D7", "severity": "medium", "location": { "page": 22, "row_positions": [ 4, 5, 6, 7 ] }, "call_made": "The four drug-specific rows 'Sample RNT (h)' and 'Sample time window' (atezolizumab, isatuximab) are header rows (schedule properties): RNT rows as timepoint at levels 4 (atezolizumab) and 5 (isatuximab), window rows as window with no level.", "alternative": "Treat the two RNT rows as parallel scales at the same level (or as per-drug activity-level timing), since neither is the parent of the other.", "report_section": "2.3" }, { "id": "D8", "severity": "high", "location": { "page": 22, "row_position": 10 }, "call_made": "Isatuximab infusion marks are placed in the columns their drawn cells cover: Cycle 1 D1 bar in columns 4-5, Cycle 2 bar in 12-13, Cycle 3 'X' in 15, Cycle 4 bar in 17-18, Subsequent Cycles 'X' in 21. In Cycles 2-4 and Subsequent these columns sit one column right of the isatuximab 'SOI' column.", "alternative": "Realign each isatuximab infusion mark to start at the isatuximab SOI column of its cycle (columns 2, 11, 14, 16, 20).", "report_section": "2.4" }, { "id": "D9", "severity": "medium", "location": { "page": 22, "row_positions": [ 12, 13 ] }, "call_made": "PK rows named with the full two-line label: 'Atezolizumab Sample ID' and 'Isatuximab Sample ID'.", "alternative": "Name them 'Atezolizumab' / 'Isatuximab' and treat 'Sample ID' as a caption saying the cells hold sample identifiers.", "report_section": "2.5" }, { "id": "D10", "severity": "low", "location": { "page": 22, "row_positions": [ 2, 3 ] }, "call_made": "Header cells merged vertically over two header rows are recorded on the upper row only: Table 02 'EOT' and 'FUP (90±7 days)' on the Cycle row (Day row empty in columns 22-23); Table 03 'Screening' on the Study phase row (Cycle/visit row empty in column 4).", "alternative": "Repeat the vertically merged value on each covered header row.", "report_section": "2.2 / 3.2" } ] }