{
  "schema_name": "soa-tables-consolidated",
  "schema_version": "1.5",
  "protocol_id": "NCT05324124",
  "consolidation_metadata": {
    "consolidated_at": "2026-10-03T15:51:09.982183+00:00",
    "consolidator": "soa2usdm.steps.consolidate v1.1",
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        "table_num": 1,
        "table_type": "main_soa",
        "table_title": "Schedule of Activities (SoA)",
        "table_purpose": "Main study schedule: screening, 11-day inpatient treatment period, ED and follow-up phone call",
        "track_label": null,
        "activity_count": 20,
        "column_count": 15,
        "annotation_count": 8,
        "property_hierarchy": [
          {
            "hierarchical_level": 1,
            "property_name": "Study period",
            "property_type": "epoch",
            "property_comment": "Top header band naming study phases: Screening (col 2), Treatment Period (merged across cols 3-15, Day -1 to ED), Follow-Up phone call (col 16). Phase names -> epoch. Label cell empty; name synthesized."
          },
          {
            "hierarchical_level": 2,
            "property_name": "Study day",
            "property_type": "study_day",
            "property_comment": "Study-day row: '-28 to -2 days prior to Day 1' (Screening), Day -1, Days 1-11, ED (early discontinuation), and for the Follow-Up column the window 'within 7 to 10 days after last dose' (vertically merged across rows 2-3 in the source). Numeric day labels -> study_day. The printed label cell reads 'Procedure', which heads the activity column, so the property name is synthesized."
          },
          {
            "hierarchical_level": null,
            "property_name": "Days",
            "property_type": "other",
            "property_comment": "Presentational band carrying the single spanning label 'Days' over cols 3-15, qualifying the numbers in row 3 as study days. It does not by itself distinguish any two columns, so hierarchical_level is null. Label cell empty; name taken from the spanning value."
          }
        ]
      }
    ],
    "match_stats": {
      "exact": 0,
      "fuzzy_auto": 0,
      "fuzzy_cross_parent": 0,
      "fuzzy_review": 0,
      "decision": 0,
      "new": 20
    },
    "review_stats": {
      "total": 0,
      "open": 0,
      "decided": 0,
      "near_matches": 0
    },
    "source_activity_count": 20,
    "unified_activity_count": 20,
    "compression_percent": 0,
    "annotation_stats": {
      "source_annotation_count": 8,
      "unified_annotation_count": 8,
      "deduplicated_count": 0,
      "deduplication_percent": 0,
      "by_type": {
        "footnote": 7,
        "source_note": 1
      }
    }
  },
  "property_hierarchy": [
    {
      "property_id": "prop-001",
      "property_type": "epoch",
      "property_name": "Study period",
      "hierarchical_level": 1,
      "property_comment": "Top header band naming study phases: Screening (col 2), Treatment Period (merged across cols 3-15, Day -1 to ED), Follow-Up phone call (col 16). Phase names -> epoch. Label cell empty; name synthesized."
    },
    {
      "property_id": "prop-003",
      "property_type": "study_day",
      "property_name": "Study day",
      "hierarchical_level": 2,
      "property_comment": "Study-day row: '-28 to -2 days prior to Day 1' (Screening), Day -1, Days 1-11, ED (early discontinuation), and for the Follow-Up column the window 'within 7 to 10 days after last dose' (vertically merged across rows 2-3 in the source). Numeric day labels -> study_day. The printed label cell reads 'Procedure', which heads the activity column, so the property name is synthesized."
    },
    {
      "property_id": "prop-002",
      "property_type": "other",
      "property_name": "Days",
      "hierarchical_level": null,
      "property_comment": "Presentational band carrying the single spanning label 'Days' over cols 3-15, qualifying the numbers in row 3 as study days. It does not by itself distinguish any two columns, so hierarchical_level is null. Label cell empty; name taken from the spanning value."
    }
  ],
  "review_queue": [],
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      "parent_name": "",
      "parent_xact_id": null,
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      "is_section_header": false,
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          "activity_id": "act-001",
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          "match_confidence": 1.0
        }
      ],
      "name_variations": [
        "Informed consent"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
    {
      "xact_id": "xact-002",
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 2,
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      "is_section_header": false,
      "source_refs": [
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          "table_id": "table-001",
          "table_num": 1,
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          "match_confidence": 1.0
        }
      ],
      "name_variations": [
        "Inclusion and exclusion criteria"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
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      "xact_id": "xact-003",
      "activity_name": "Demography",
      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 3,
      "qualified_key": "::Demography",
      "is_section_header": false,
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        {
          "table_id": "table-001",
          "table_num": 1,
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          "row_position": 6,
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          "match_confidence": 1.0
        }
      ],
      "name_variations": [
        "Demography"
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      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
    {
      "xact_id": "xact-004",
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 4,
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      "is_section_header": false,
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        {
          "table_id": "table-001",
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          "row_position": 7,
          "match_status": "new",
          "match_confidence": 1.0
        }
      ],
      "name_variations": [
        "Participant admission to CRU"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
    {
      "xact_id": "xact-005",
      "activity_name": "Participant discharge from CRU",
      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 5,
      "qualified_key": "::Participant discharge from CRU",
      "is_section_header": false,
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          "table_id": "table-001",
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          "match_confidence": 1.0
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      ],
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        "Participant discharge from CRU"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
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      "xact_id": "xact-006",
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      "parent_xact_id": null,
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        {
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          "match_confidence": 1.0
        }
      ],
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        "Outpatient visit"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
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      "is_section_header": false,
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          "table_id": "table-001",
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          "match_confidence": 1.0
        }
      ],
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        "Medical history"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
    {
      "xact_id": "xact-008",
      "activity_name": "Medical assessment",
      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 8,
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      "is_section_header": false,
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        {
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          "match_confidence": 1.0
        }
      ],
      "name_variations": [
        "Medical assessment"
      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
    {
      "xact_id": "xact-009",
      "activity_name": "Height and weight",
      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
      "display_order": 9,
      "qualified_key": "::Height and weight",
      "is_section_header": false,
      "source_refs": [
        {
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      ],
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      "table_count": 1
    },
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      "parent_name": "",
      "parent_xact_id": null,
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      ],
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      "table_count": 1
    },
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      "xact_id": "xact-011",
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      "parent_name": "",
      "parent_xact_id": null,
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      "is_section_header": false,
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        }
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      ],
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      "match_confidence": 1.0,
      "table_count": 1
    },
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
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      "qualified_key": "::Human immunodeficiency virus, hepatitis B and C screen",
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      ],
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      "match_confidence": 1.0,
      "table_count": 1
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
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      "is_section_header": false,
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          "match_confidence": 1.0
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        "12-lead ECG"
      ],
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      "match_confidence": 1.0,
      "table_count": 1
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      "parent_name": "",
      "parent_xact_id": null,
      "hierarchy_level": 0,
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      ],
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      "parent_xact_id": null,
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      "parent_name": "",
      "parent_xact_id": null,
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      "is_redacted": true,
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  ],
  "timeline_segments": {
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        "segment": "main",
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            "value": ""
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        ],
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          }
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      },
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          }
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      "consolidated_value": "↔",
      "source_values": {
        "1": "↔"
      }
    },
    {
      "xact_id": "xact-019",
      "xcol_id": "xcol-014",
      "consolidated_value": "X",
      "source_values": {
        "1": "X"
      }
    }
  ],
  "unified_annotations": [
    {
      "xannot_id": "xannot-001",
      "annotation_type": "footnote",
      "annotation_text": "A study participant may be required to stay later than Day 11 for management or monitoring of an AE or a clinically significant finding, at the discretion of the investigator.",
      "display_markers": "T1:cm1",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm1",
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        }
      ],
      "referenced_xacts": [
        "xact-005"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-002",
      "annotation_type": "footnote",
      "annotation_text": "Full medical assessment to be performed at screening, and symptom driven examination to be done at other/any time point at physician’s discretion.",
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      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm2",
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        }
      ],
      "referenced_xacts": [
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      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-003",
      "annotation_type": "footnote",
      "annotation_text": "Height and weight to be measured at screening; weight only to be measured at Day 11 or ED as appropriate.",
      "display_markers": "T1:cm3",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm3",
          "annotation_id": "annot-003"
        }
      ],
      "referenced_xacts": [
        "xact-009"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-004",
      "annotation_type": "footnote",
      "annotation_text": "Serum pregnancy tests will be performed at screening and urine pregnancy test at all other time points",
      "display_markers": "T1:cm4",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm4",
          "annotation_id": "annot-004"
        }
      ],
      "referenced_xacts": [
        "xact-010"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-005",
      "annotation_type": "footnote",
      "annotation_text": "Single ECGs are required.",
      "display_markers": "T1:cm5",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm5",
          "annotation_id": "annot-005"
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      ],
      "referenced_xacts": [
        "xact-013"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-006",
      "annotation_type": "footnote",
      "annotation_text": "Time points may be added, if warranted and agreed upon between Lilly and the investigator.",
      "display_markers": "T1:cm6",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm6",
          "annotation_id": "annot-006"
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      "referenced_xacts": [
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-007",
      "annotation_type": "source_note",
      "annotation_text": "See Appendix 10.2, Clinical Laboratory Tests, for details.",
      "display_markers": "T1:cm7",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm7",
          "annotation_id": "annot-007"
        }
      ],
      "referenced_xacts": [
        "xact-015"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "appendix",
          "target": "10.2"
        }
      ]
    },
    {
      "xannot_id": "xannot-008",
      "annotation_type": "footnote",
      "annotation_text": "Participant consumes high-fat meal within 30 minutes prior to dose based on randomization.",
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      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "cm8",
          "annotation_id": "annot-008"
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      "referenced_xacts": [
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      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
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  ],
  "review_items": [
    {
      "table_number": 1,
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 12,
        "row_positions": [
          19,
          20
        ]
      },
      "call_made": "The black 'CCI' redaction box between 'Genetic sample' and 'Selpercatinib administration' (full table width) is treated as hiding unknown content; no activity rows were created for it.",
      "alternative": "Add one or more placeholder activity rows (e.g. 'Redacted (CCI)') with no marks, so the concealed rows are represented in the schedule.",
      "report_section": "3.1"
    },
    {
      "table_number": 1,
      "id": "D2",
      "severity": "high",
      "location": {
        "page": 12,
        "row_positions": [
          21,
          22
        ]
      },
      "call_made": "The double-headed arrow in 'Adverse event /Serious adverse event review' and 'Concomitant medication review' is recorded as one merged cell covering Day 1 to Day 11 (columns 4-14), and is distributed as '↔' to each of those 11 columns.",
      "alternative": "Limit the arrow to the columns the drawn arrow physically crosses (tip-to-tip roughly Day 1 to Day 10) instead of the full merged cell.",
      "report_section": "3.2"
    },
    {
      "table_number": 1,
      "id": "D3",
      "severity": "medium",
      "location": {
        "page": 9,
        "row_positions": [
          2,
          3
        ],
        "column_position": 16
      },
      "call_made": "The Follow-Up column's text 'within 7 to 10 days after last dose', printed in a cell merged down across header rows 2-3, is stored on the study-day row (row 3); row 2 is left empty for that column.",
      "alternative": "Store it as a separate visit-window property, or on row 2, since the source cell spans both rows.",
      "report_section": "3.3"
    },
    {
      "table_number": 1,
      "id": "D4",
      "severity": "low",
      "location": {
        "page": 12
      },
      "call_made": "The abbreviation line under the table (CRU, ECG, ED, h; tail redacted as CCI) is not emitted as annotations, because none of these terms is printed as a marker; they only occur as ordinary words in labels and cells.",
      "alternative": "Emit abbreviation annotations ab1-ab4 (CRU, ECG, ED, h) bound to the labels/cells where those words appear.",
      "report_section": "3.4"
    }
  ]
}