{ "schema_name": "soa-tables-consolidated", "schema_version": "1.5", "protocol_id": "NCT03637764", "consolidation_metadata": { "consolidated_at": "2026-10-03T15:50:56.862946+00:00", "consolidator": "soa2usdm.steps.consolidate v1.1", "source_tables": [ { "table_id": "table-001", "table_num": 1, "table_type": "main_soa", "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_purpose": "Main study schedule: screening, treatment cycles, end of treatment and post-treatment follow-up", "track_label": null, "activity_count": 29, "column_count": 10, "annotation_count": 13, "property_hierarchy": [ { "hierarchical_level": 1, "property_name": "Study Phase", "property_type": "epoch", "property_comment": "Top header band naming the study phases: Screening (up to 28 days before Day 1), Treatment Phase, End of Treatment (EOT), Post Treatment Follow-up Phase. Major study phases -> epoch. Label column is empty (the 'Evaluation' activity-column header spans all header rows), so the name is synthesised." }, { "hierarchical_level": 2, "property_name": "Cycle / Follow-up Period", "property_type": "period", "property_comment": "Second header band sub-dividing the phases: Cycle 1, Cycle 2 and Beyond (treatment cycles of 21 days per footnote a), Safety follow-up Period, Survival follow-up; empty under Screening and EOT. Mixes treatment cycles with follow-up sub-periods, so classified as period (sub-phases) rather than cycle. Name synthesised (label column empty)." }, { "hierarchical_level": 3, "property_name": "Study Day / Visit Timing", "property_type": "study_day", "property_comment": "Lowest header band giving the day of each column with its window: D-28 to D-15, D-14 to D-1, D1 (±1), D8 (± 1), D15 (±1), D1 (± 2), and relative follow-up days (30 (±7) days after last IMPs admin, At 60/At 90 (±7) days after last IMPs admin, Every 90 days (±7) after last safety follow-up). Protocol day values -> study_day. Name synthesised (label column empty)." } ] }, { "table_id": "table-002", "table_num": 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", "track_label": null, "activity_count": 9, "column_count": 22, "annotation_count": 10, "property_hierarchy": [ { "hierarchical_level": 1, "property_name": "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": 2, "property_name": "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": 3, "property_name": "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": 4, "property_name": "Sample RNT (h) Ref: SOI Atezolizumab", "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": 5, "property_name": "Sample RNT (h) Ref: 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": null, "property_name": "Sample time window Atezolizumab", "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, "property_name": "Sample time window 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." } ] }, { "table_id": "table-003", "table_num": 3, "table_type": "subsidiary", "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_purpose": "Exploratory biomarker blood draws and tumor tissue/biopsy collection by cycle", "track_label": null, "activity_count": 16, "column_count": 7, "annotation_count": 5, "property_hierarchy": [ { "hierarchical_level": 1, "property_name": "Study phase", "property_type": "epoch", "property_comment": "Phase band: 'Screening' (4, cell merged down over the next header row), 'Treatment Phase' (5:8), 'Post-Treatment Phase' (9:10). Label columns hold the column captions 'Sample Collection' / 'Biomarker Analysis' (merged over all 3 header rows), so the name is synthesised. Major study phases -> epoch." }, { "hierarchical_level": 2, "property_name": "Cycle / visit", "property_type": "cycle", "property_comment": "Cycle 1, Cycle 2, Cycle 3, Cycle 5 and Beyond (no Cycle 4 column is printed), then EOT and Follow-up. Column 4 is covered by the vertically merged 'Screening' cell. Mostly treatment cycles -> cycle; EOT / Follow-up are visit-like values in the same row. Name synthesised (no row label)." }, { "hierarchical_level": 3, "property_name": "Day / timing", "property_type": "study_day", "property_comment": "Day of cycle or relative timing: D-28 to D-1, D1 (-1 day)[a], D1, D1, D1, 30 (±7) days after last IMP admin, 60 (±7) days after last IMP admin. Predominantly study days -> study_day; the post-treatment values are offsets from last IMP. Name synthesised (no row label)." } ], "refines": [ { "xact_id": "xact-027", "correction_id": "ccorr-003" } ] } ], "match_stats": { "exact": 0, "fuzzy_auto": 0, "fuzzy_cross_parent": 0, "fuzzy_review": 0, "decision": 0, "new": 54 }, "review_stats": { "total": 0, "open": 0, "decided": 0, "near_matches": 0 }, "corrections_applied": 5, "source_activity_count": 54, "unified_activity_count": 54, "compression_percent": 0, "annotation_stats": { "source_annotation_count": 28, "unified_annotation_count": 28, "deduplicated_count": 0, "deduplication_percent": 0, "by_type": { "footnote": 19, "source_note": 9 } } }, "property_hierarchy": [ { "property_id": "prop-001", "property_type": "epoch", "property_name": "Study Phase", "hierarchical_level": 1, "property_comment": "Top header band naming the study phases: Screening (up to 28 days before Day 1), Treatment Phase, End of Treatment (EOT), Post Treatment Follow-up Phase. Major study phases -> epoch. Label column is empty (the 'Evaluation' activity-column header spans all header rows), so the name is synthesised." }, { "property_id": "prop-002", "property_type": "period", "property_name": "Cycle / Follow-up Period", "hierarchical_level": 2, "property_comment": "Second header band sub-dividing the phases: Cycle 1, Cycle 2 and Beyond (treatment cycles of 21 days per footnote a), Safety follow-up Period, Survival follow-up; empty under Screening and EOT. Mixes treatment cycles with follow-up sub-periods, so classified as period (sub-phases) rather than cycle. Name synthesised (label column empty)." }, { "property_id": "prop-003", "property_type": "study_day", "property_name": "Study Day / Visit Timing", "hierarchical_level": 3, "property_comment": "Lowest header band giving the day of each column with its window: D-28 to D-15, D-14 to D-1, D1 (±1), D8 (± 1), D15 (±1), D1 (± 2), and relative follow-up days (30 (±7) days after last IMPs admin, At 60/At 90 (±7) days after last IMPs admin, Every 90 days (±7) after last safety follow-up). Protocol day values -> study_day. Name synthesised (label column empty)." }, { "property_id": "prop-004", "property_type": "timepoint", "property_name": "Sample RNT (h) Ref: SOI Atezolizumab", "hierarchical_level": 4, "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." }, { "property_id": "prop-006", "property_type": "timepoint", "property_name": "Sample RNT (h) Ref: SOI Isatuximab", "hierarchical_level": 5, "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." }, { "property_id": "prop-005", "property_type": "window", "property_name": "Sample time window Atezolizumab", "hierarchical_level": null, "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." }, { "property_id": "prop-007", "property_type": "window", "property_name": "Sample time window Isatuximab", "hierarchical_level": null, "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." } ], "review_queue": [], "unified_activities": [ { "xact_id": "xact-001", "activity_name": "Informed consent/ Inclusion and exclusion criteria", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 1, "qualified_key": "::Informed consent/ Inclusion and exclusion criteria", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-001", "row_position": 4, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Informed consent/ Inclusion and exclusion criteria" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-002", "activity_name": "Demography, Medical/Surgical and Disease History", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 2, "qualified_key": "::Demography, Medical/Surgical and Disease History", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-002", "row_position": 5, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Demography, Medical/Surgical and Disease History" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-003", "activity_name": "Physical examination", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 3, "qualified_key": "::Physical examination", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-003", "row_position": 6, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Physical examination" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-004", "activity_name": "Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM)", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 4, "qualified_key": "::Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM)", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-004", "row_position": 7, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM)" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-005", "activity_name": "Vital Signs", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 5, "qualified_key": "::Vital Signs", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-005", "row_position": 8, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Vital Signs" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-006", "activity_name": "Resting O2 saturation for SCCHN", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 6, "qualified_key": "::Resting O2 saturation for SCCHN", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-006", "row_position": 9, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Resting O2 saturation for SCCHN" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-007", "activity_name": "12-Lead ECG", "parent_name": "", "parent_xact_id": null, "hierarchy_level": 0, "display_order": 7, "qualified_key": "::12-Lead ECG", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-007", "row_position": 10, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "12-Lead ECG" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-008", "activity_name": "Laboratory Assessments", "parent_name": "", "parent_xact_id": null, 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1 }, { "xact_id": "xact-012", "activity_name": "Coagulation(GBM)", "parent_name": "Laboratory Assessments", "parent_xact_id": "xact-008", "hierarchy_level": 1, "display_order": 12, "qualified_key": "Laboratory Assessments::Coagulation(GBM)", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-012", "row_position": 15, "match_status": "new", "match_confidence": 1.0 } ], "name_variations": [ "Coagulation(GBM)" ], "match_status": "new", "match_confidence": 1.0, "table_count": 1 }, { "xact_id": "xact-013", "activity_name": "Coagulation (for HCC, SCCHN, and EOC)", "parent_name": "Laboratory Assessments", "parent_xact_id": "xact-008", "hierarchy_level": 1, "display_order": 13, "qualified_key": "Laboratory Assessments::Coagulation (for HCC, SCCHN, and EOC)", "is_section_header": false, "source_refs": [ { "table_id": "table-001", "table_num": 1, "activity_id": "act-013", "row_position": 16, "match_status": "new", "match_confidence": 1.0 } 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sample must be collected even if the participant withdraws the study without receiving the second administration of isatuximab.", "display_markers": "T2:d", "source_occurrences": [ { "table_num": 2, "marker": "d", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-035" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-035", "xcol_id": "xcol-017" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-018", "annotation_type": "footnote", "annotation_text": "After start of study treatment, if 1 drug is prematurely discontinued, ADA samples for this drug will be collected and tested on Day 1 of the 2 next cycles. The ADA sample collection for other drug should be done as planned.", "display_markers": "T2:e", "source_occurrences": [ { "table_num": 2, "marker": "e", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-036" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-019", "annotation_type": "footnote", "annotation_text": "Sample collected just before actual end of infusion of isatuximab.", "display_markers": "T2:f", "source_occurrences": [ { "table_num": 2, "marker": "f", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-035" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-035", "xcol_id": "xcol-014" }, { "xact_id": "xact-035", "xcol_id": "xcol-019" }, { "xact_id": "xact-035", "xcol_id": "xcol-022" }, { "xact_id": "xact-035", "xcol_id": "xcol-027" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-020", "annotation_type": "footnote", "annotation_text": "Isatuximab sample collected strictly before the start of isatuximab infusion (during treatment phase).", "display_markers": "T2:g", "source_occurrences": [ { "table_num": 2, "marker": "g", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-038" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-035", "xcol_id": "xcol-017" }, { "xact_id": "xact-035", "xcol_id": "xcol-018" }, { "xact_id": "xact-035", "xcol_id": "xcol-020" }, { "xact_id": "xact-035", "xcol_id": "xcol-023" }, { "xact_id": "xact-035", "xcol_id": "xcol-025" }, { "xact_id": "xact-035", "xcol_id": "xcol-029" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-021", "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.", "display_markers": "T2:h", "source_occurrences": [ { "table_num": 2, "marker": "h", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-038" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-038", "xcol_id": "xcol-032" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-022", "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.", "display_markers": "T2:i", "source_occurrences": [ { "table_num": 2, "marker": "i", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-033", "xact-035", "xact-036", "xact-038" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-023", "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.", "display_markers": "T2:j", "source_occurrences": [ { "table_num": 2, "marker": "j", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-034", "xact-037" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-034", "xcol_id": "xcol-029" }, { "xact_id": "xact-037", "xcol_id": "xcol-029" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-024", "annotation_type": "footnote", "annotation_text": "Biomarker blood draw may be performed within 1 working day prior to IMP administration.", "display_markers": "T3:a", "source_occurrences": [ { "table_num": 3, "marker": "a", "annotation_id": "annot-001" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-034" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-025", "annotation_type": "footnote", "annotation_text": "Only for Phase 2 Stage 2 participants", "display_markers": "T3:n1", "source_occurrences": [ { "table_num": 3, "marker": "n1", "annotation_id": "annot-002" } ], "referenced_xacts": [ "xact-042", "xact-043" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-026", "annotation_type": "footnote", "annotation_text": "Only Phase 2 Stage 2 participants, if sufficient clinical response is observable in Phase 1 and Phase 2 Stage 1 participants", "display_markers": "T3:n2", "source_occurrences": [ { "table_num": 3, "marker": "n2", "annotation_id": "annot-003" } ], "referenced_xacts": [ "xact-044", "xact-045" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-027", "annotation_type": "footnote", "annotation_text": "Mandatory for all GBM participants. For HCC, SCCHN, and EOC participants, provision of adequate archival tumor tissue is allowed to replace mandatory baseline biopsy", "display_markers": "T3:n3", "source_occurrences": [ { "table_num": 3, "marker": "n3", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-047" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-028", "annotation_type": "footnote", "annotation_text": "Refer to I 02 for details. At least 1 tumor core is required, but 3 cores are optimal. Refer to Laboratory Manual for details.", "display_markers": "T3:n4", "source_occurrences": [ { "table_num": 3, "marker": "n4", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-050", "xact-052", "xact-054" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 } ], "review_items": [ { "table_number": 1, "id": "D1", "severity": "high", "location": { "page": 22 }, "call_made": "Only the Schedule of Activities table on document pages 18-21 (the declared SoA range) was extracted. The 'Pharmacokinetics and Immunogenicity Flow Chart' (pages 22-23) and the 'Exploratory Biomarker Flow Chart' (page 24), which the SoA's PK / ADA / Tumor Biopsy rows point to, were not extracted.", "alternative": "Extract the two flow charts as additional tables (Table 02 PK/immunogenicity, Table 03 biomarkers), each typed 'subsidiary' because they give finer timing for the PK, ADA and biomarker activities of Table 01.", "report_section": "3.1" }, { "table_number": 1, "id": "D2", "severity": "medium", "location": { "page": 21, "row_positions": [ 28, 29, 30 ] }, "call_made": "The merged text 'See Pharmacokinetics and immunogenicity Flow Chart' (PK, ADA rows) and 'See Biomarker Flow Chart' (Tumor Biopsy/Archival Tissue/Biomarker row) is kept as a cell value distributed across every data column 2-11 (source_range 2:11). The printed cell also runs into the Notes column, which is not a data column.", "alternative": "Treat each of these as a cross-reference (source_note annotation on the activity) and leave the grid cells of these three rows empty.", "report_section": "3.3" }, { "table_number": 1, "id": "D3", "severity": "medium", "location": { "page": 18, "row_position": 2 }, "call_made": "Header row 2 (Cycle 1 / Cycle 2 and Beyond / Safety follow-up Period / Survival follow-up) is typed 'period' because it mixes treatment cycles with follow-up sub-periods.", "alternative": "Type it 'cycle' (the treatment-phase entries are cycles) or 'other'.", "report_section": "3.5" }, { "table_number": 1, "id": "D4", "severity": "medium", "location": { "page": 20, "row_positions": [ 17, 18, 19, 24, 25, 26, 27, 28, 29, 30, 31, 32 ] }, "call_made": "Blood Typing Interference Test, Serology and Urinalysis (top of page 20) are placed under 'Laboratory Assessments' (indentation 1) across the page break; the bold rows Isatuximab Administration and Atezolizumab Administration and all page-21 rows are top level (indentation 0), not children of 'Disease Assessment'.", "alternative": "Treat the page-20 lab rows as top-level, and/or treat the rows after the Disease Assessment block as children of 'Disease Assessment'.", "report_section": "3.5" }, { "table_number": 1, "id": "D5", "severity": "high", "location": { "page": 20, "row_position": 24, "annotation_marker": "c" }, "call_made": "Footnote c ('evaluation not applicable for Cohort E') is printed in the Notes cell beside Isatuximab Administration but is bound to every cell carrying a printed superscript c (the D8 and D15 marks of 8 rows, 16 cells), not to the Isatuximab row alone.", "alternative": "Also bind footnote c to the Isatuximab Administration row as a whole (because its definition sits in that row's Notes cell), or restrict it to the Isatuximab Administration cells only.", "report_section": "3.4" }, { "table_number": 1, "id": "D6", "severity": "medium", "location": { "page": 20, "row_positions": [ 17, 21, 22, 23 ] }, "call_made": "Qualified entries in the 'Cycle 2 and Beyond D1' column - 'Cycle 2 Day 1 only' (Blood Typing) and 'X (Weeks 9, 18, 27, and then every 12 weeks)' / 'X (Weeks 6, 12, 18, 24, and then every 9 weeks)' (imaging, tumour markers) - are kept literally in that single column because the qualifiers name timings that are not separate columns of the table.", "alternative": "Normalise these to a bare 'X' and move the timing qualifier into a synthesised footnote on the cell.", "report_section": "3.3" }, { "table_number": 2, "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" }, { "table_number": 2, "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" }, { "table_number": 2, "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" }, { "table_number": 2, "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" }, { "table_number": 3, "id": "D11", "severity": "high", "location": { "page": 24, "row_positions": [ 4, 11, 13, 14, 16, 18 ] }, "call_made": "The three label columns are turned into a hierarchy: each left-hand Sample Collection label (Peripheral Blood, Archival ..., Baseline or on treatment tumor biopsy core ...) becomes a mark-free level-0 grouping row, each 'Core n' a level-1 row, and the Biomarker Analysis text the activity that carries the marks (level 1, or level 2 under a Core). row_position is renumbered in reading order (header 1-3, body 4-19), so it is not the physical row. Notes-column cells bind to the mark-carrying analysis row.", "alternative": "Keep one activity per physical row (10 body rows) named by the Biomarker Analysis text only, carrying the Sample Collection and Core labels in cell_text or joined into the name (e.g. 'Core 1 CD38 and PD-L1 ...').", "report_section": "3.3" }, { "table_number": 3, "id": "D12", "severity": "medium", "location": { "page": 24 }, "call_made": "Table typed subsidiary: a finer per-cycle breakdown of the single main-SoA row 'Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw - See Biomarker Flow Chart'.", "alternative": "Type it main_soa as an independent schedule with its own column set (its columns are not a strict refinement of the main SoA's columns: it adds Cycle 2, Cycle 3 and 'Cycle 5 and Beyond' and drops D8/D15).", "report_section": "3.1" }, { "table_number": 3, "id": "D13", "severity": "high", "location": { "page": 24, "row_positions": [ 15, 17, 19 ], "annotation_marker": "n4" }, "call_made": "The Notes cell beside the three biopsy-core rows is one rule-bounded cell with two paragraphs; it is one note ('Refer to I 02 for details. At least 1 tumor core is required ...') bound to all three core analysis rows.", "alternative": "Split into two notes: 'Refer to I 02 for details.' on Core 1 only and 'At least 1 tumor core is required, but 3 cores are optimal. Refer to Laboratory Manual for details.' on Core 2 (or on all three cores).", "report_section": "3.5" } ] }