NCT05259917 — SoA extraction uncertainty report

Source: NCT05259917_soa.pdf (2 PDF pages = document pages 17-18 per PAGEMAP.md). KVD900-301 KONFIDENT protocol, Version 4.1 (US Only), 04 May 2023. No protocol markdown was available; all text comes from the PDF text layer. Output: NCT05259917_Table_01_extraction.json (one table).

Decisions needed (3)

# where call made alternative detail
D1 p.17, rows 3-4 ("In-clinic", "TeleVisit") These two rows are recorded as visit-type header rows (how each visit is held), not as activities; footnotes d/e attach to them. Record them as two ordinary activity rows with their X marks, exactly as printed in the body. 2.2
D2 p.17, rows 3-4, Randomization column (marker a) The single X printed centred across the In-clinic and TeleVisit rows is recorded on both rows (Randomization visit may be either, per footnote a). Put the mark on one row only, or record it as a single either/or condition. 2.3
D3 p.17, header row 1 ("Visit") Header row 1 is typed "visit", following its printed label; "Treatment Period" is a spanning group over the three attack visits. Type header row 1 as "epoch" (Screening / Randomization / Treatment Period / Final). 2.1

Recorded, not open (6)

1. Table summary

2. Judgement calls (detail)

2.1 Header row 1 property_type (D3). The label cell reads "Visit" and spans both header rows; values mix named visits (Screening, Randomization, Final Visit/ET — each vertically merged over rows 1-2) and a spanning period "Treatment Period" (cols 4-6). Row 2 ("1st/2nd/3rd eligible HAE attack") has an empty label cell, so its property_name "Eligible HAE attack" is synthesised (property_name_source.synthesized = true). Row 2 has no grid values in cols 2, 3, 7 (vertical merge from row 1 is not expressible in the schema).

2.2 In-clinic / TeleVisit (D1). These rows mark visit modality, the pattern the prompt describes as Telephone-visit bands (schedule_property). Recorded as property_type modality, hierarchical_level null, X values in schedule_grid: In-clinic cols 2, 3, 7; TeleVisit cols 3, 4, 5, 6.

2.3 Vertically merged Randomization mark (D2). The bbox y of this X (186) sits between the In-clinic (178) and TeleVisit (194) rows, and the page render shows no horizontal rule between the two rows in column 3. Per §5 (vertically merged marks) it is emitted on both rows.

3. Merged-mark decisions

4. Synthesised

5. Mechanical mark-check

pdftotext -bbox; column centres fixed from the header labels (x ≈ 339, 412, 493, 565, 634, 695 pt); X tokens binned to the nearest centre. The bbox matrix agrees cell-for-cell with the visual read (54 marks including arrows; arrows are vector graphics and were checked visually only). No disagreements.

6. Annotation text integrity

7. Low-confidence calls

8. Orphan risk

9. Method provenance