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Any subjects with positive titers for antibodies to AMG 416 may be asked to return to the clinical research unit to provide additional serum samples.", "display_markers": "T2:f", "source_occurrences": [ { "table_num": 2, "marker": "f", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-028" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-016", "annotation_type": "footnote", "annotation_text": "Luteinizing hormone and estradiol levels may additionally be collected if deemed necessary for confirmation of postmenopausal status as described in exclusion criteria section 4.2.4", "display_markers": "T2:g", "source_occurrences": [ { "table_num": 2, "marker": "g", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-022" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "4.2.4" } ] }, { "xannot_id": "xannot-017", "annotation_type": "footnote", "annotation_text": "Time: Pre HD", "display_markers": "T2:t1", "source_occurrences": [ { "table_num": 2, "marker": "t1", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-016", "xact-017", "xact-018", "xact-019", "xact-020", "xact-021", "xact-022", "xact-023", "xact-024", "xact-025", "xact-026", "xact-027", "xact-028" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-018", "annotation_type": "footnote", "annotation_text": "Definition of footnote 'a' (on the 29/ET column header) is not printed in the source for Table 1c; only the abbreviation line 'HD = hemodialysis; ET = early termination; SDA = Study drug administration.' follows the table. Probable equivalent (NOT source content for this table): Table 1b footnote a - 'If a treated subject withdraws from study before completion of dosing, the investigator will make every effort to obtain day 29 samples as close to 2 days after the last dose of investigational product as possible.'", "display_markers": "T3:a", "source_occurrences": [ { "table_num": 3, "marker": "a", "annotation_id": "annot-001" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-057" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "table", "target": "1" } ] } ], "review_items": [ { "table_number": 1, "id": "D1", "severity": "low", "location": { "page": 32, "row_position": 2 }, "call_made": "The '(HD)' printed under a day number is kept inside that day's header value (e.g. '3 (HD)'), as one header row, in all three tables.", "alternative": "Split '(HD)' into a separate header row (modality: hemodialysis day) so day number and HD flag are separate properties.", "report_section": "2.1" }, { "table_number": 2, "id": "D2", "severity": "high", "location": { "page": 34, "row_positions": [ 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 ], "annotation_marker": "t1" }, "call_made": "The Time column's single 'Pre HD' cell, which is merged vertically down all 13 laboratory rows (rule lines confirm no break), is recorded as one note ('Time: Pre HD') attached to every laboratory row; activity names stay as printed.", "alternative": "Apply 'Pre HD' only to the first row (Hematology, PT, aPTT) where the text is printed, or fold 'Pre HD' into each laboratory activity name.", "report_section": "3.3" }, { "table_number": 3, "id": "D3", "severity": "medium", "location": { "page": 36 }, "call_made": "Table 1c is typed 'domain' (same day columns and same participants as Table 1a, PK category).", "alternative": "Type it 'subsidiary' (finer PK timing for a subset of activities), since its rows are sampling times relative to dosing.", "report_section": "4.1" }, { "table_number": 3, "id": "D4", "severity": "medium", "location": { "page": 36, "row_positions": [ 4, 5, 6, 7, 8, 9 ] }, "call_made": "The Time label column value is folded into each activity name: 'PK (Pre HD)', 'PK (SDA + 10 min)', ... 'PK (SDA + 18 to 30 hr)'.", "alternative": "Keep every row's name as the printed 'PK' and carry the time value separately (e.g. as a per-row note), accepting six rows with the same name.", "report_section": "4.3" }, { "table_number": 3, "id": "D5", "severity": "medium", "location": { "page": 36, "row_position": 3 }, "call_made": "The 'Central Laboratory' band printed across the day columns is a level-0 section-header row grouping the PK rows (no marks).", "alternative": "Treat it as a header property/condition row (where samples are analysed) or as a table-level note rather than an activity row.", "report_section": "4.3" }, { "table_number": 3, "id": "D6", "severity": "medium", "location": { "page": 36, "row_position": 2, "column_position": 19, "annotation_marker": "a" }, "call_made": "Marker 'a' on the 29/ET header is kept; its annotation says the definition is not printed for Table 1c and cites Table 1b footnote a as a probable (unasserted) equivalent.", "alternative": "Assert Table 1b footnote a's wording as this table's footnote a, or drop the marker as undefined.", "report_section": "4.4" } ] }