{
  "schema_name": "soa-table-extraction",
  "schema_version": "1.0",
  "extraction_metadata": {
    "extracted_at": "2026-09-27T10:37:28+02:00",
    "extractor": "Claude, PDF_TO_JSON_PROMPT single-pass",
    "prompt_version": "3.8.1",
    "source_document": {
      "filename": "NCT02107703_soa.pdf",
      "document_type": "protocol",
      "document_version": "I3Y-MC-JPBL Clinical Protocol (Attachment 1, Protocol JPBL Study Schedule)"
    },
    "extraction_status": "ready_for_resolution",
    "extraction_notes": "Table 2 of 2: extension-period schedule, document page 78. Text layer present; grid spans confirmed from the 200-dpi raster (section 1d).",
    "model": "claude-opus-5-5"
  },
  "table_metadata": {
    "table_number": 2,
    "table_type": "track",
    "track_label": "Extension period",
    "table_title": "Study Schedule for the extension period only, Protocol I3Y-MC-JPBL",
    "table_purpose": "Schedule for patients continuing study treatment in the extension period after study completion",
    "page_start": 78,
    "page_end": 78,
    "notes": "Typed track, not main_soa: the title restricts it to the extension period, which begins after study completion (footnote a), and it has its own visit numbering (501-5XX, 901). This is a separate study phase for the patients who continue treatment. Three leading label columns; data columns 4-6. Subtitle: 'Perform procedure as indicated.' Row 6 (column-label band) not emitted. Protocol Reference entries emitted as source_note annotations, with pr markers continuing the study-wide numbering from Table 1."
  },
  "schedule_properties": [
    {
      "table_number": 2,
      "row_position": 1,
      "property_name": "Study period",
      "property_name_source": {
        "row_position": 1,
        "column_position": 3,
        "cell_value": "",
        "synthesized": true
      },
      "property_type": "epoch",
      "property_comment": "Top header band with an empty label cell: Patients on Study Treatment (cols 4-5), Extension Period Follow-Up (col 6). Study phases, so epoch; name synthesised (same name as Table 1).",
      "hierarchical_level": 1
    },
    {
      "table_number": 2,
      "row_position": 2,
      "property_name": "Cycle",
      "property_name_source": {
        "row_position": 2,
        "column_position": 3,
        "cell_value": "Cycle"
      },
      "property_type": "cycle",
      "property_comment": "Cycle identifiers: X-Y (extension treatment cycles, cols 4-5) and Follow-Up (col 6, footnote a). Typed cycle from the row label.",
      "hierarchical_level": 2
    },
    {
      "table_number": 2,
      "row_position": 3,
      "property_name": "Visit",
      "property_name_source": {
        "row_position": 3,
        "column_position": 3,
        "cell_value": "Visit"
      },
      "property_type": "visit",
      "property_comment": "Visit numbers 501-5XX and 901; named visits, so visit.",
      "hierarchical_level": 3
    },
    {
      "table_number": 2,
      "row_position": 4,
      "property_name": "Duration (days)",
      "property_name_source": {
        "row_position": 4,
        "column_position": 3,
        "cell_value": "Duration (days)"
      },
      "property_type": "other",
      "property_comment": "Duration of each cycle/period in days (28, 30). A duration qualifier, so other; level null because it does not distinguish columns.",
      "hierarchical_level": null
    },
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      "table_number": 2,
      "row_position": 5,
      "property_name": "Relative day within a cycle",
      "property_name_source": {
        "row_position": 5,
        "column_position": 3,
        "cell_value": "Relative day within a cycle"
      },
      "property_type": "study_day",
      "property_comment": "Day within the cycle (1, 15; follow-up cell shaded/blank). Day values, so study_day; splits the treatment column into two.",
      "hierarchical_level": 4
    }
  ],
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      "merged_cell_range": "4:5"
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      "merged_cell_range": "4:5"
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      "annotation_markers": "a"
    },
    {
      "table_number": 2,
      "row_position": 3,
      "column_position": 4,
      "cell_value": "501-5XX",
      "is_merged_cell": true,
      "merged_cell_range": "4:5"
    },
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      "table_number": 2,
      "row_position": 3,
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      "is_merged_cell": true,
      "merged_cell_range": "4:5"
    },
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      "table_number": 2,
      "row_position": 3,
      "column_position": 6,
      "cell_value": "901"
    },
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      "table_number": 2,
      "row_position": 4,
      "column_position": 4,
      "cell_value": "28",
      "is_merged_cell": true,
      "merged_cell_range": "4:5"
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      "table_number": 2,
      "row_position": 4,
      "column_position": 5,
      "cell_value": "28",
      "is_merged_cell": true,
      "merged_cell_range": "4:5"
    },
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      "table_number": 2,
      "row_position": 4,
      "column_position": 6,
      "cell_value": "30"
    },
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      "table_number": 2,
      "row_position": 5,
      "column_position": 4,
      "cell_value": "1"
    },
    {
      "table_number": 2,
      "row_position": 5,
      "column_position": 5,
      "cell_value": "15"
    },
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      "table_number": 2,
      "row_position": 5,
      "column_position": 6,
      "cell_value": ""
    }
  ],
  "activities": [
    {
      "table_number": 2,
      "row_position": 7,
      "source_page": 78,
      "activity_name": "Adverse Events Collection/CTCAE Grading",
      "activity_name_source": {
        "cell_text": "Adverse Events Collection/CTCAE Gradingb",
        "indentation_level": 0,
        "indentation_method": "visual_estimate",
        "text_formatting": [
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      },
      "annotation_markers": "b,pr9"
    },
    {
      "table_number": 2,
      "row_position": 8,
      "source_page": 78,
      "activity_name": "Study Drug",
      "activity_name_source": {
        "cell_text": "Study Drug",
        "indentation_level": 0,
        "indentation_method": "visual_estimate",
        "text_formatting": [
          "bold"
        ]
      }
    },
    {
      "table_number": 2,
      "row_position": 9,
      "source_page": 78,
      "activity_name": "Fulvestrant Therapy",
      "activity_name_source": {
        "cell_text": "Fulvestrant Therapyc",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "c,pr20"
    },
    {
      "table_number": 2,
      "row_position": 10,
      "source_page": 78,
      "activity_name": "LY2835219 Therapy",
      "activity_name_source": {
        "cell_text": "LY2835219 Therapyc",
        "indentation_level": 1,
        "indentation_method": "visual_estimate"
      },
      "annotation_markers": "c,pr20"
    }
  ],
  "activity_schedule": [
    {
      "table_number": 2,
      "row_position": 7,
      "column_position": 4,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 7,
      "column_position": 6,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 9,
      "column_position": 4,
      "cell_value": "Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond",
      "source_range": "4:5",
      "annotation_markers": "c"
    },
    {
      "table_number": 2,
      "row_position": 9,
      "column_position": 5,
      "cell_value": "Days 1 and 15 of Cycle 1, then Day 1 of Cycle 2 and beyond",
      "source_range": "4:5",
      "annotation_markers": "c"
    },
    {
      "table_number": 2,
      "row_position": 10,
      "column_position": 4,
      "cell_value": "Daily every 12 hours",
      "source_range": "4:5",
      "annotation_markers": "c"
    },
    {
      "table_number": 2,
      "row_position": 10,
      "column_position": 5,
      "cell_value": "Daily every 12 hours",
      "source_range": "4:5",
      "annotation_markers": "c"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "a",
      "annotation_type": "footnote",
      "annotation_text": "The extension period begins after study completion and ends at the end of trial.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 2,
          "column_position": 6
        }
      ]
    },
    {
      "annotation_marker": "b",
      "annotation_type": "footnote",
      "annotation_text": "Data on SAEs that occur before the end of trial will be stored in the collection database and the Lilly safety system.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 7
        }
      ]
    },
    {
      "annotation_marker": "c",
      "annotation_type": "footnote",
      "annotation_text": "LY2835219 should be administered every 12 hours on Days 1 through 28 of each cycle. Patients should not consume food beginning 1 hour before and ending hour after taking study drug. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 9
        },
        {
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          "row_position": 9,
          "column_position": 4
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 9,
          "column_position": 5
        },
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 10
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 10,
          "column_position": 4
        },
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 10,
          "column_position": 5
        }
      ]
    },
    {
      "annotation_marker": "pr9",
      "annotation_type": "source_note",
      "annotation_text": "Section 10.3",
      "marker_locations": [
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          "location_type": "activity_name",
          "row_position": 7,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "pr20",
      "annotation_type": "source_note",
      "annotation_text": "Section 8.1.2",
      "marker_locations": [
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        },
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        }
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    }
  ],
  "review_items": [
    {
      "id": "D6",
      "severity": "medium",
      "location": {
        "page": 78
      },
      "call_made": "This extension-period schedule is typed as a separate 'track' labelled 'Extension period': patients continue treatment after study completion, with their own visits (501-5XX, 901).",
      "alternative": "Type it main_soa, as an independent schedule with its own columns, and do not label it as a track.",
      "report_section": "4.1"
    },
    {
      "id": "D7",
      "severity": "high",
      "location": {
        "page": 78,
        "row_positions": [
          9,
          10
        ]
      },
      "call_made": "The dosing text for Fulvestrant and LY2835219 is spread across both Day 1 and Day 15 (columns 4-5), as the ruled merged cell shows.",
      "alternative": "Anchor the text to Day 1 only (column 4).",
      "report_section": "4.2"
    }
  ]
}