{ "schema_name": "soa-tables-consolidated", "schema_version": "1.5", "protocol_id": "NCT04184622", "consolidation_metadata": { "consolidated_at": "2026-10-04T08:21:20.242337+00:00", "consolidator": "soa2usdm.steps.consolidate v1.1", "source_tables": [ { "table_id": "table-001", "table_num": 1, "table_type": "main_soa", "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_purpose": "Main 72-week treatment schedule (screening, treatment to primary endpoint at Week 72, Visit 99, early discontinuation and safety follow-up Visit 801) for all participants.", "track_label": null, "activity_count": 54, "column_count": 24, "annotation_count": 27, "property_hierarchy": [ { "hierarchical_level": 1, "property_name": "Visit", "property_type": "visit", "property_comment": "Visit identifiers (1–21, 99, ED, 801 in Table 1; 101–116, 199, ED, 802 in Table 2); a named/numbered visit per column, so property_type visit. Uniquely identifies every column." }, { "hierarchical_level": 2, "property_name": "Week of Treatment", "property_type": "week", "property_comment": "Week of treatment relative to randomization (negative weeks = screening/lead-in; last column reads \"N wks Post TxP\"). Numeric week labels, so property_type week. ED column is empty." }, { "hierarchical_level": null, "property_name": "Allowable Deviation (days)", "property_type": "window", "property_comment": "Visit window in days (±3, +7, ±7). Allowed deviation around the target date, so property_type window. Empty for the first visit and for ED." }, { "hierarchical_level": null, "property_name": "Fasting Visit", "property_type": "visit_attribute", "property_comment": "X marks visits at which the participant must attend fasting. A per-visit attribute, not a timing level; typed visit_attribute; does not distinguish columns, so hierarchical_level null." }, { "hierarchical_level": null, "property_name": "Telephone Visit", "property_type": "modality", "property_comment": "X marks visits conducted by telephone (these columns are grey-shaded in the body). Visit type/modality, so property_type modality; does not distinguish columns, so hierarchical_level null." } ] }, { "table_id": "table-002", "table_num": 2, "table_type": "track", "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_purpose": "Additional 2-year treatment period (Weeks 78-176, Visits 101-116, 199, ED, 802) for participants with prediabetes at randomization only.", "track_label": "Prediabetes", "activity_count": 39, "column_count": 19, "annotation_count": 18, "property_hierarchy": [ { "hierarchical_level": 1, "property_name": "Visit", "property_type": "visit", "property_comment": "Visit identifiers (1–21, 99, ED, 801 in Table 1; 101–116, 199, ED, 802 in Table 2); a named/numbered visit per column, so property_type visit. Uniquely identifies every column." }, { "hierarchical_level": 2, "property_name": "Week of Treatment", "property_type": "week", "property_comment": "Week of treatment relative to randomization (negative weeks = screening/lead-in; last column reads \"N wks Post TxP\"). Numeric week labels, so property_type week. ED column is empty." }, { "hierarchical_level": null, "property_name": "Allowable Deviation (days)", "property_type": "window", "property_comment": "Visit window in days (±3, +7, ±7). Allowed deviation around the target date, so property_type window. Empty for the first visit and for ED." }, { "hierarchical_level": null, "property_name": "Fasting Visit", "property_type": "visit_attribute", "property_comment": "X marks visits at which the participant must attend fasting. A per-visit attribute, not a timing level; typed visit_attribute; does not distinguish columns, so hierarchical_level null." }, { "hierarchical_level": null, "property_name": "Telephone Visit", "property_type": "modality", "property_comment": "X marks visits conducted by telephone (these columns are grey-shaded in the body). Visit type/modality, so property_type modality; does not distinguish columns, so hierarchical_level null." } ] } ], "match_stats": { "exact": 31, "fuzzy_auto": 5, "fuzzy_cross_parent": 2, "fuzzy_review": 0, "decision": 0, "new": 55 }, "review_stats": { "total": 7, "open": 0, "decided": 7, "near_matches": 0 }, "corrections_applied": 7, "source_activity_count": 93, "unified_activity_count": 55, "compression_percent": 41, "annotation_stats": { "source_annotation_count": 45, "unified_annotation_count": 27, "deduplicated_count": 18, "deduplication_percent": 40, "by_type": { "footnote": 27 } } }, "property_hierarchy": [ { "property_id": "prop-001", "property_type": "visit", "property_name": "Visit", "hierarchical_level": 1, "property_comment": "Visit identifiers (1–21, 99, ED, 801 in Table 1; 101–116, 199, ED, 802 in Table 2); a named/numbered visit per column, so property_type visit. Uniquely identifies every column." }, { "property_id": "prop-002", "property_type": "week", "property_name": "Week of Treatment", "hierarchical_level": 2, "property_comment": "Week of treatment relative to randomization (negative weeks = screening/lead-in; last column reads \"N wks Post TxP\"). Numeric week labels, so property_type week. ED column is empty." }, { "property_id": "prop-003", "property_type": "window", "property_name": "Allowable Deviation (days)", "hierarchical_level": null, "property_comment": "Visit window in days (±3, +7, ±7). Allowed deviation around the target date, so property_type window. Empty for the first visit and for ED." }, { "property_id": "prop-004", "property_type": "visit_attribute", "property_name": "Fasting Visit", "hierarchical_level": null, "property_comment": "X marks visits at which the participant must attend fasting. A per-visit attribute, not a timing level; typed visit_attribute; does not distinguish columns, so hierarchical_level null." }, { "property_id": "prop-005", "property_type": "modality", "property_name": "Telephone Visit", "hierarchical_level": null, "property_comment": "X marks visits conducted by telephone (these columns are grey-shaded in the body). 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In the event of systemic drug hypersensitivity reactions (immediate or nonimmediate), additional blood samples will be collected including ADA, PK, and exploratory biomarker samples.", "display_markers": "T1-2:n24", "source_occurrences": [ { "table_num": 1, "marker": "n24", "annotation_id": "annot-024" }, { "table_num": 2, "marker": "n24", "annotation_id": "annot-016" } ], "referenced_xacts": [ "xact-040" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 2 }, { "xannot_id": "xannot-025", "annotation_type": "footnote", "annotation_text": "PK samples will be collected at these visits at time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose, as assigned by IWRS at randomization. Dependent on the time windows to which a participant is assigned, they may be required to come to site for PK-specific visits.", "display_markers": "T1:n25", "source_occurrences": [ { "table_num": 1, "marker": "n25", "annotation_id": "annot-025" } ], "referenced_xacts": [ "xact-041" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-026", "annotation_type": "footnote", "annotation_text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed.", "display_markers": "T1-2:n26", "source_occurrences": [ { "table_num": 1, "marker": "n26", "annotation_id": "annot-026" }, { "table_num": 2, "marker": "n26", "annotation_id": "annot-017" } ], "referenced_xacts": [ "xact-045", "xact-046", "xact-047", "xact-048" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 2 }, { "xannot_id": "xannot-027", "annotation_type": "footnote", "annotation_text": "Self-Harm Follow-up Form is only required if triggered by the Self-Harm Supplement Form, per instructions in the form.", "display_markers": "T1-2:n27", "source_occurrences": [ { "table_num": 1, "marker": "n27", "annotation_id": "annot-027" }, { "table_num": 2, "marker": "n27", "annotation_id": "annot-018" } ], "referenced_xacts": [ "xact-049" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 2 } ], "review_items": [ { "table_number": 1, "id": "D1", "severity": "high", "location": { "page": 18, "row_position": 1, "annotation_marker": "n1" }, "call_made": "Every '*' in the table was treated as pointing to one specific note of the 'Additional Information' table (pages 25-28): each note got its own id (n1-n27) and was attached to the starred row, visit or cell whose name matches that note's Activity cell.", "alternative": "Treat '*' as a single generic pointer ('see table below') and emit one annotation bound to every starred element, leaving the note-to-element matching to a later step.", "report_section": "3.1" }, { "table_number": 1, "id": "D2", "severity": "high", "location": { "page": 19, "row_position": 25, "column_position": 22, "annotation_marker": "n16" }, "call_made": "The note 'Dispense study drug Visit 72' (only for participants continuing into the prediabetes 2-year period) is attached only to the starred X of Dispense study drug at Visit 21 (Week 72), the one cell printed 'X*'.", "alternative": "Attach the note to the whole Dispense study drug row (all visits), since the note's own label names 'Visit 72', which does not exist as a visit number.", "report_section": "3.2" }, { "table_number": 1, "id": "D3", "severity": "high", "location": { "page": 20, "row_positions": [ 38, 39, 40, 41, 44 ], "column_position": 2, "annotation_marker": "n22" }, "call_made": "The eligibility note for Urinary albumin/creatinine, Cystatin-c, Calcitonin, Hematology and TSH ('Screening visit assessment will be used to confirm eligibility ...') is attached only to their starred Visit 1 cells, where the '*' is printed.", "alternative": "Attach it to the five activity rows as a whole (all visits), and also to the same-named rows of Table 2 which carry no '*'.", "report_section": "3.2" }, { "table_number": 1, "id": "D4", "severity": "medium", "location": { "page": 18, "row_positions": [ 4, 5 ] }, "call_made": "'Fasting Visit' and 'Telephone Visit' (blue-shaded header rows reprinted on every page) are recorded as header properties (Fasting = other, Telephone = modality), not as activities.", "alternative": "Record them as activity rows with X marks at the fasting / telephone visits.", "report_section": "3.3" }, { "table_number": 1, "id": "D5", "severity": "medium", "location": { "page": 21, "row_position": 51 }, "call_made": "The activity name is transcribed literally as printed: 'C-SSRS (Baseline/Screening) Version)', including the stray parenthesis.", "alternative": "Normalise to 'C-SSRS (Baseline/Screening Version)', the spelling used in the Additional Information table.", "report_section": "3.4" }, { "table_number": 2, "id": "D6", "severity": "medium", "location": { "page": 22 }, "call_made": "Table 2 (section 1.3.2) is typed 'track' with label 'Prediabetes': a separate 2-year schedule (Visits 101-116, 199, ED, 802; Weeks 78-176) only for participants with prediabetes at randomization.", "alternative": "Type it 'main_soa' (an independent schedule with its own columns) rather than a population/phase track.", "report_section": "4.1" }, { "table_number": 2, "id": "D7", "severity": "low", "location": { "page": 24, "row_position": 1 }, "call_made": "The line '*Please see table below for corresponding additional information' is not emitted as its own annotation; its content is carried by the 27 per-note annotations it points to.", "alternative": "Emit it as an additional source_note annotation with marker '*' attached at table level.", "report_section": "4.3" } ] }