{
  "schema_name": "soa-table-extraction",
  "schema_version": "1.0",
  "extraction_metadata": {
    "extracted_at": "2026-09-27T13:08:28Z",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT04573309_soa.pdf",
      "document_type": "amendment",
      "document_version": "Protocol Amendment 3.1 (US), ALXN1840-WD-204",
      "document_date": "18 Mar 2022"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "Text-layer PDF with vector rule lines; marks bbox-binned to header time point columns; body is one cell (no internal horizontal rule) holding two activity labels.",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_number": 2,
    "table_type": "subsidiary",
    "table_title": "Table 2: Schedule of Pharmacokinetic and Pharmacodynamic Assessments on Days 1, 25, 29, and 39",
    "table_purpose": "Hour-level PK/PD sampling times on Days 1, 25, 29 and 39",
    "page_start": 17,
    "page_end": 17,
    "notes": "Subsidiary: finer (hourly) timing for the PK and PD blood-sampling activities of Table 1 on Days 1, 25, 29 and 39 (Table 1 footnotes o and p point here). One label column (L=1); data columns 2-12."
  },
  "schedule_properties": [
    {
      "table_number": 2,
      "row_position": 1,
      "property_name": "Time point (hours)",
      "property_name_source": {
        "row_position": 1,
        "column_position": 1,
        "cell_value": "Time point (hours)a"
      },
      "property_type": "timepoint",
      "hierarchical_level": 1,
      "annotation_markers": "a,n1",
      "property_comment": "Hours relative to dosing (0 hours) on Days 1, 25, 29 and 39: −0.5, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24. Within-day sampling times -> timepoint."
    }
  ],
  "schedule_grid": [
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 2,
      "cell_value": "−0.5"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 3,
      "cell_value": "0"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 4,
      "cell_value": "1"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 5,
      "cell_value": "2"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 6,
      "cell_value": "3"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 7,
      "cell_value": "4"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 8,
      "cell_value": "5"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 9,
      "cell_value": "6"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 10,
      "cell_value": "8"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 11,
      "cell_value": "12"
    },
    {
      "table_number": 2,
      "row_position": 1,
      "column_position": 12,
      "cell_value": "24"
    }
  ],
  "activities": [
    {
      "table_number": 2,
      "row_position": 2,
      "source_page": 17,
      "activity_name": "Blood sampling for PK: Plasma total Mo and PUF-Mo",
      "activity_name_source": {
        "cell_text": "Blood sampling for PK: Plasma total Mo and PUF-Mo",
        "indentation_level": 0,
        "indentation_method": "assumed_flat"
      }
    },
    {
      "table_number": 2,
      "row_position": 3,
      "source_page": 17,
      "activity_name": "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu",
      "activity_name_source": {
        "cell_text": "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu",
        "indentation_level": 0,
        "indentation_method": "assumed_flat"
      }
    }
  ],
  "activity_schedule": [
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 5,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 7,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 9,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 10,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 11,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 2,
      "column_position": 12,
      "cell_value": "X",
      "annotation_markers": "b"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 5,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 7,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 8,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 9,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 10,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 11,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 12,
      "cell_value": "X",
      "annotation_markers": "b"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "a",
      "annotation_type": "footnote",
      "annotation_text": "Time points are relative to dosing (0 hours).",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1
        }
      ]
    },
    {
      "annotation_marker": "b",
      "annotation_type": "footnote",
      "annotation_text": "Hour 24 PK/PD sampling is to occur just prior to the next-day dose of ALXN1840.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 12
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 3,
          "column_position": 12
        }
      ]
    },
    {
      "annotation_marker": "n1",
      "annotation_type": "footnote",
      "annotation_text": "Note: Windows for PK/PD time points will be defined as ±10% of the nominal time point. On Days 1 and 39, triplicate 12-lead ECG will be collected at 4 hours postdose. When multiple procedures are scheduled to occur at the same time, the following order of events should be strictly adhered to whenever possible: ECG, vital signs, blood sampling (eg, for PK/PD), study intervention administration, and meal.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "method": "synthesized"
        }
      ]
    }
  ],
  "review_items": [
    {
      "id": "D4",
      "severity": "medium",
      "location": {
        "page": 17,
        "row_positions": [
          2,
          3
        ]
      },
      "call_made": "The single body cell of Table 2, which lists 'Blood sampling for PK: Plasma total Mo and PUF-Mo' and 'PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu' on separate lines with one set of marks, is split into two activities (matching the two Table 1 rows) and every mark is emitted on both.",
      "alternative": "Keep it as one combined activity 'Blood sampling for PK ... / PD ...' carrying the marks once.",
      "report_section": "3.2"
    }
  ]
}