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  "schema_version": "1.5",
  "protocol_id": "NCT04557384",
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    "consolidated_at": "2026-10-04T08:21:21.897485+00:00",
    "consolidator": "soa2usdm.steps.consolidate v1.1",
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        "table_type": "main_soa",
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        "table_purpose": "Main schedule: screening, on-treatment cycles, and short-term follow-up",
        "track_label": null,
        "activity_count": 25,
        "column_count": 15,
        "annotation_count": 23,
        "property_hierarchy": [
          {
            "hierarchical_level": 1,
            "property_name": "Epoch",
            "property_type": "epoch",
            "property_comment": "Study-phase band: 'Screening' (cols 2-3, merged vertically over rows 2-3), 'On-Treatment' (cols 4-15), 'Post-Treatment' (col 16, merged vertically over rows 2-3). Major study phases -> epoch. Label cell empty (label column is one merged blank cell over rows 2-6); name synthesised."
          },
          {
            "hierarchical_level": 2,
            "property_name": "Cycle length",
            "property_type": "other",
            "property_comment": "Cycle-duration band under On-Treatment: 'Cycle = 21 days' (cols 4-6, Cycle 1) and 'Cycle = 21 days (or 28 days for Cohorts B & C per combination regimen)' (cols 7-15, Cycle 2 onward). Groups cycles by duration rule; not itself a visit/cycle identifier, so typed 'other'. Cols 2-3 and 16 are the vertical continuation of the row-2 Screening/Post-Treatment cells (left empty here). Label cell empty; name synthesised."
          },
          {
            "hierarchical_level": 3,
            "property_name": "Cycle",
            "property_type": "cycle",
            "property_comment": "Cycle identifiers: 'Cycle 1' (cols 4-6), 'Cycle 2' (cols 7-10), 'Cycle 2-n (If combo therapy is held and ramucirumab is given)' (col 11), 'Cycle 3-n' (cols 12-15), 'Short-term follow-up' with footnote a (col 16); screening cols 2-3 carry the qualifier '(Day Relative to C1D1)' (merged vertically over rows 4-5). Treatment cycles -> cycle. Label cell empty; name synthesised."
          },
          {
            "hierarchical_level": 4,
            "property_name": "Day",
            "property_type": "study_day",
            "property_comment": "Day labels per column: screening days '≤28', '≤7' (relative to C1D1), cycle days D1/D8/D15 (Cycle 1), D1/D8/D15/D22 (Cycle 2), 'DX' (additional ramucirumab dose when combination held), D1/D8/D15/D22 (Cycle 3-n), and visit code 'V801' for short-term follow-up. Predominantly days within cycle -> study_day (V801 is a visit code, noted). Carries the Instructions-column note 'D22 for 28-day cycles only.' (synthesised marker i1). Label cell empty; name synthesised."
          },
          {
            "hierarchical_level": null,
            "property_name": "Visit window",
            "property_type": "window",
            "property_comment": "Allowed visit windows '(±3 days)' per cycle block (cols 4-6, 7-10, 11, 12-15) and for col 16. Cols 2-3 are the vertical continuation of the row-4 '(Day Relative to C1D1)' cell. Windows -> window; presentational qualifier that does not distinguish columns, hence hierarchical_level null. Label cell empty; name synthesised."
          }
        ]
      },
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        "table_type": "track",
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        "table_purpose": "Schedule for participants in the continued-access period",
        "track_label": "Continued Access",
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        "column_count": 2,
        "annotation_count": 4,
        "property_hierarchy": [
          {
            "hierarchical_level": 1,
            "property_name": "Epoch",
            "property_type": "epoch",
            "property_comment": "Phase labels 'Study Treatment' (col 2) and 'Follow-Up' with footnote a (col 3) of the continued-access period -> epoch. Label cell of rows 2-3 is one merged cell whose text 'Visit' sits on row 3; this row's name is synthesised."
          },
          {
            "hierarchical_level": 2,
            "property_name": "Visit",
            "property_type": "visit",
            "property_comment": "Visit numbers '501-5XX' (col 2, repeating study-treatment visits) and '901' (col 3, follow-up visit) -> visit. Name taken from the printed label 'Visit'."
          }
        ]
      },
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        "table_id": "table-003",
        "table_num": 3,
        "table_type": "subsidiary",
        "table_title": "Pharmacokinetic Sampling Schedule",
        "table_purpose": "Detailed PK and immunogenicity sample timing (Section 1.3.1) for the 'Sample collection: PK / IG' rows of Table 1",
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        "activity_count": 15,
        "column_count": 5,
        "annotation_count": 4,
        "property_hierarchy": [
          {
            "hierarchical_level": 1,
            "property_name": "Column heading",
            "property_type": "other",
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        ]
      }
    ],
    "match_stats": {
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      "fuzzy_auto": 1,
      "fuzzy_cross_parent": 0,
      "fuzzy_review": 0,
      "decision": 0,
      "new": 41
    },
    "review_stats": {
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      "open": 0,
      "decided": 15,
      "near_matches": 14
    },
    "corrections_applied": 15,
    "source_activity_count": 43,
    "unified_activity_count": 41,
    "compression_percent": 5,
    "annotation_stats": {
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      "unified_annotation_count": 31,
      "deduplicated_count": 0,
      "deduplication_percent": 0,
      "by_type": {
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        "source_note": 2
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      "property_type": "epoch",
      "property_name": "Epoch",
      "hierarchical_level": 1,
      "property_comment": "Study-phase band: 'Screening' (cols 2-3, merged vertically over rows 2-3), 'On-Treatment' (cols 4-15), 'Post-Treatment' (col 16, merged vertically over rows 2-3). Major study phases -> epoch. Label cell empty (label column is one merged blank cell over rows 2-6); name synthesised."
    },
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      "property_type": "other",
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    },
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    },
    {
      "property_id": "prop-004",
      "property_type": "window",
      "property_name": "Visit window",
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      "property_comment": "Allowed visit windows '(±3 days)' per cycle block (cols 4-6, 7-10, 11, 12-15) and for col 16. Cols 2-3 are the vertical continuation of the row-4 '(Day Relative to C1D1)' cell. Windows -> window; presentational qualifier that does not distinguish columns, hence hierarchical_level null. Label cell empty; name synthesised."
    }
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  "review_queue": [],
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      "parent_xact_id": null,
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      "match_status": "new",
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      "table_count": 1
    },
    {
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      "parent_xact_id": null,
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      "match_status": "new",
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      "is_section_header": false,
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      "name_variations": [
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      "match_status": "new",
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    },
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      "parent_xact_id": null,
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          "match_confidence": 1.0
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      ],
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      ],
      "match_status": "new",
      "match_confidence": 1.0,
      "table_count": 1
    },
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      "parent_xact_id": null,
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          "match_confidence": 1.0
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      ],
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      "table_count": 1
    },
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          "match_status": "fuzzy_auto",
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          "decision": {
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            "op": "keep"
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        "AE Collection"
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      "parent_xact_id": null,
      "hierarchy_level": 0,
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      "display_markers": "T1:i16",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i16",
          "annotation_id": "annot-018"
        }
      ],
      "referenced_xacts": [
        "xact-018"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "8.2.5"
        }
      ]
    },
    {
      "xannot_id": "xannot-019",
      "annotation_type": "footnote",
      "annotation_text": "1. ISR questionnaire completed outside of solicited assessment schedule.\n2. May be triggered by participant anytime during the cycle based on diary.\n3. If the participant indicates presence of pain during spontaneous ISR reporting, no VAS assessment is required.",
      "display_markers": "T1:i17",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i17",
          "annotation_id": "annot-019"
        }
      ],
      "referenced_xacts": [
        "xact-019"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-020",
      "annotation_type": "footnote",
      "annotation_text": "• Participant will assess injection site(s) daily. If any ISR symptoms present, the participant should contact the investigator.\n• Diary should be returned to the investigator at each weekly visit.",
      "display_markers": "T1:i18",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i18",
          "annotation_id": "annot-020"
        }
      ],
      "referenced_xacts": [
        "xact-020"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-021",
      "annotation_type": "source_note",
      "annotation_text": "See Section 1.3.1 for PK and IG.",
      "display_markers": "T1:i19",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i19",
          "annotation_id": "annot-021"
        }
      ],
      "referenced_xacts": [
        "xact-021"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "1.3.1"
        }
      ]
    },
    {
      "xannot_id": "xannot-022",
      "annotation_type": "footnote",
      "annotation_text": "See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the administration of SC ramucirumab (see Section 6.1).",
      "display_markers": "T1:i20",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i20",
          "annotation_id": "annot-022"
        }
      ],
      "referenced_xacts": [
        "xact-024"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "6.1"
        }
      ]
    },
    {
      "xannot_id": "xannot-023",
      "annotation_type": "footnote",
      "annotation_text": "Begin Combination anti-cancer therapies along with weekly SC ramucirumab at Cycle-2. See details in Section 6.1. Erlotinib (1L EGFR+ NSCLC), docetaxel (2L NSCLC), paclitaxel (2L gastric), FOLFIRI (2L CRC).",
      "display_markers": "T1:i21",
      "source_occurrences": [
        {
          "table_num": 1,
          "marker": "i21",
          "annotation_id": "annot-023"
        }
      ],
      "referenced_xacts": [
        "xact-025"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "6.1"
        }
      ]
    },
    {
      "xannot_id": "xannot-024",
      "annotation_type": "footnote",
      "annotation_text": "Continued-access follow-up begins when the participant and the investigator agree that the participant will no longer continue treatment in the continued-access period and lasts a minimum of 30 days following the last dose of study drug. In all cases, no follow-up procedures will be performed for a participant who withdraws informed consent unless he or she has explicitly provided permission and consent.",
      "display_markers": "T2:a",
      "source_occurrences": [
        {
          "table_num": 2,
          "marker": "a",
          "annotation_id": "annot-001"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [
        "xcol-017"
      ],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-025",
      "annotation_type": "footnote",
      "annotation_text": "Grading via CTCAE, Version 5.0. As part of AE collection, monitor vital signs and perform standard laboratory tests (hematology, chemistry, urinalysis, and pregnancy testing) at the same frequency as during the study treatment period. See Section 10.3 for AE grading for lab investigations. All laboratory tests during the continued access period will be performed in the local laboratories only.",
      "display_markers": "T2:i1",
      "source_occurrences": [
        {
          "table_num": 2,
          "marker": "i1",
          "annotation_id": "annot-002"
        }
      ],
      "referenced_xacts": [
        "xact-008"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "10.3"
        }
      ]
    },
    {
      "xannot_id": "xannot-026",
      "annotation_type": "footnote",
      "annotation_text": "In the event of hypersensitivity, blood samples will be collected for PK, IG, and exploratory hypersensitivity analyses at the following time points, as close as possible to: (i) the onset of the hypersensitivity, (ii) the resolution of the hypersensitivity, and (iii) 30 (±3) days following the hypersensitivity.",
      "display_markers": "T2:i2",
      "source_occurrences": [
        {
          "table_num": 2,
          "marker": "i2",
          "annotation_id": "annot-003"
        }
      ],
      "referenced_xacts": [
        "xact-026"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1
    },
    {
      "xannot_id": "xannot-027",
      "annotation_type": "footnote",
      "annotation_text": "See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the ramucirumab injection (see Section 6.1).",
      "display_markers": "T2:i3",
      "source_occurrences": [
        {
          "table_num": 2,
          "marker": "i3",
          "annotation_id": "annot-004"
        }
      ],
      "referenced_xacts": [
        "xact-024"
      ],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "document_references": [
        {
          "kind": "section",
          "target": "6.1"
        }
      ]
    },
    {
      "xannot_id": "xannot-028",
      "annotation_type": "footnote",
      "annotation_text": "The pharmacokinetic sampling table applies to all participants irrespective of 21-day or 28-day cycle length.",
      "display_markers": "T3:g1",
      "source_occurrences": [
        {
          "table_num": 3,
          "marker": "g1",
          "annotation_id": "annot-001"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "annotation_scope": "table"
    },
    {
      "xannot_id": "xannot-029",
      "annotation_type": "footnote",
      "annotation_text": "Adequately record the actual collection date and time (24-hour clock; for example, 16:00, not 4 pm) on the requisition form of the sample.",
      "display_markers": "T3:g2",
      "source_occurrences": [
        {
          "table_num": 3,
          "marker": "g2",
          "annotation_id": "annot-002"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "annotation_scope": "table"
    },
    {
      "xannot_id": "xannot-030",
      "annotation_type": "footnote",
      "annotation_text": "In case of cycle delay and/or ramucirumab dosing interruption, if possible, collect an additional unscheduled PK samples using the appropriate central lab collection kit:\n• at time as close as possible to the onset of the adverse event (AE) (if the cycle delay or ramucirumab dosing interruption is due to an AE).\n• at the time when ramucirumab dose should have been administered (if there had not been a delay or dose interruption).\n• prior to resuming the ramucirumab dosing after dosing interruption/dosing delay.",
      "display_markers": "T3:g3",
      "source_occurrences": [
        {
          "table_num": 3,
          "marker": "g3",
          "annotation_id": "annot-003"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "annotation_scope": "table"
    },
    {
      "xannot_id": "xannot-031",
      "annotation_type": "footnote",
      "annotation_text": "Note: If the above time points for unscheduled PK sampling happen to occur at the same time as a scheduled PK time point (see table below), then only the scheduled sample will be taken.",
      "display_markers": "T3:g4",
      "source_occurrences": [
        {
          "table_num": 3,
          "marker": "g4",
          "annotation_id": "annot-004"
        }
      ],
      "referenced_xacts": [],
      "referenced_xcols": [],
      "referenced_props": [],
      "cell_references": [],
      "occurrence_count": 1,
      "annotation_scope": "table"
    }
  ],
  "review_items": [
    {
      "table_number": 1,
      "id": "D1",
      "severity": "high",
      "location": {
        "page": 19,
        "row_position": 22,
        "annotation_marker": "i13"
      },
      "call_made": "The unlabelled row at the top of page 19 (empty cells; shading identical to the Pregnancy test row) is treated as the page-broken continuation of the Pregnancy test row: no activity row is created and its Instructions text ('Note: During study treatment, perform monthly ... See Appendix 2.') is joined to the Pregnancy test note.",
      "alternative": "Treat the page-19 row as a separate unnamed row / separate note (e.g. bound to Thyroid panel or table scope).",
      "report_section": "3.1"
    },
    {
      "table_number": 1,
      "id": "D2",
      "severity": "high",
      "location": {
        "page": 20,
        "row_position": 25,
        "annotation_marker": "i16"
      },
      "call_made": "Page 20's only body row (unlabelled, empty cells, shading/merges identical to Injection site assessments (solicited)) is treated as the continuation of that row: no activity row; its Instructions text (C1D1...C1D15 and Cycle 2-n timings, ISR questionnaire, Pain VAS, See Section 8.2.5) is joined to the solicited-ISR note.",
      "alternative": "Treat the page-20 text as a separate note or separate row.",
      "report_section": "3.1"
    },
    {
      "table_number": 1,
      "id": "D3",
      "severity": "high",
      "location": {
        "page": 22,
        "row_position": 32,
        "column_position": 11
      },
      "call_made": "'Administer combination medications' row: the white 'See instructions' cell ends on a rule inside the DX column (about one quarter into DX); the rest of DX is grey. Recorded as 'See instructions' over cols 4-10 and 12-15, with DX (col 11) empty.",
      "alternative": "Extend the first span to include DX (4:11), i.e. combination medications also 'See instructions' at DX.",
      "report_section": "3.2"
    },
    {
      "table_number": 1,
      "id": "D4",
      "severity": "high",
      "location": {
        "page": 16,
        "row_position": 6,
        "column_position": 11,
        "annotation_marker": "n1"
      },
      "call_made": "The 'Note:' printed above the table on page 16 (procedures noted in column DX performed at the additional ramucirumab doses) is bound to the DX column cell of the Day header row (row 6, col 11) with synthesised marker n1.",
      "alternative": "Bind it to the Cycle-row DX cell (row 4, col 11), or treat it as table-scope.",
      "report_section": "3.3"
    },
    {
      "table_number": 1,
      "id": "D5",
      "severity": "high",
      "location": {
        "page": 16,
        "row_position": 6,
        "annotation_marker": "i1"
      },
      "call_made": "The Instructions-column text on the Day header row, 'D22 for 28-day cycles only.', is bound to the whole Day header row (schedule_property row 6) as marker i1.",
      "alternative": "Bind it only to the two D22 columns (row 6, cols 10 and 15) as cell-level notes.",
      "report_section": "3.3"
    },
    {
      "table_number": 1,
      "id": "D6",
      "severity": "high",
      "location": {
        "page": 21,
        "row_position": 28,
        "annotation_marker": "i19"
      },
      "call_made": "'See Section 1.3.1 for PK and IG.' (Instructions cell of the 'Sample collection' header row) is bound only to that header row (row 28).",
      "alternative": "Also bind it to the PK and IG child rows (rows 29-30).",
      "report_section": "3.3"
    },
    {
      "table_number": 1,
      "id": "D7",
      "severity": "medium",
      "location": {
        "page": 16,
        "row_position": 3
      },
      "call_made": "Header row 3 ('Cycle = 21 days' / 'Cycle = 21 days (or 28 days for Cohorts B & C ...)') is typed 'other' at hierarchy level 2.",
      "alternative": "Type it 'period' (sub-phase grouping) or 'cycle', or give it level null as a presentational qualifier.",
      "report_section": "3.4"
    },
    {
      "table_number": 2,
      "id": "D8",
      "severity": "medium",
      "location": {
        "page": 23
      },
      "call_made": "Typed 'track' (track_label 'Continued Access'): a separate schedule for participants who continue study treatment in the continued-access period after the main study, with its own visit numbering (501-5XX, 901).",
      "alternative": "Type it 'main_soa' (an independent schedule table) rather than a separate timeline track.",
      "report_section": "4.1"
    },
    {
      "table_number": 3,
      "id": "D9",
      "severity": "medium",
      "location": {
        "page": 24
      },
      "call_made": "Typed 'subsidiary' and transcribed in its printed orientation: one row per sample ('Sample 1' ... 'Sample 14', 'End of treatment'), with Study Cycle, Day within Cycle and Collection Time Point as data columns 2-4 and the PK / Immunogenicity X marks in columns 5-6 (L=1).",
      "alternative": "Type it 'reference' (rows are samples, not procedures), or treat cols 2-4 as row-label columns (L=4, data starting at col 5), or transpose so samples become timepoint columns and PK / IG collection become the activities.",
      "report_section": "5.1"
    },
    {
      "table_number": 3,
      "id": "D10",
      "severity": "low",
      "location": {
        "page": 24,
        "row_positions": [
          2,
          3,
          4,
          5,
          6,
          7,
          8,
          9,
          10,
          11,
          12,
          13,
          14,
          15
        ]
      },
      "call_made": "Sample rows are named 'Sample 1' ... 'Sample 14' by combining the column heading 'Sample #' with the printed number (cell_text keeps the bare number); the last row keeps its printed name 'End of treatment'.",
      "alternative": "Use the bare printed numbers ('1' ... '14') as activity names.",
      "report_section": "5.2"
    },
    {
      "table_number": 3,
      "id": "D11",
      "severity": "medium",
      "location": {
        "page": 24,
        "row_position": 1
      },
      "call_made": "The four 'General Instructions' paragraphs printed above the table (applies to all cycle lengths; record date/time; unscheduled PK samples on delay/interruption; scheduled sample takes precedence) are captured as table-scope footnotes g1-g4 anchored to the header row.",
      "alternative": "Leave them out as section prose that is not part of the table.",
      "report_section": "5.3"
    }
  ]
}