NCT04677179 — SoA extraction uncertainty report

Source: NCT04677179_soa.pdf (Protocol J1P-MC-KFAH(b)), 30 PDF pages = document pages 17–46 (PAGEMAP.md). Printed footers run one lower than the document page and were not used. No protocol markdown was available. Prompt 3.8.1, single pass. Four tables extracted.

Decisions needed (13)

# where call made alternative detail
D1 p17–23, Table 1 row 5 (same in Tables 2–4) The shaded "Fasting visit" band (X at the fasting visits, reprinted on every page) is a header schedule_property, not an activity Record "Fasting visit" as a level-0 activity row with X marks T1.3
D2 p17, Table 1 Visit number row, marker t1 Title-cell note "V1 and V9 procedures may be conducted over more than 1 day…" bound to the V1 and V9 header cells Treat as a table-wide note on the Visit number row T1.5
D3 p17, Table 1 rows 6–17 (and top rows of Tables 2–4) Rows above the first section header (Informed consent … Alcohol and caffeine use; Concomitant medications … Tobacco use in Tables 2–4) recorded at indentation level 0 as stand-alone activities Level 1 under an implicit unnamed group T1.4
D4 p24, Table 2 Typed track, track_label "Responders" (schedule applies only to responders at Week 12; exclusive with Table 3) main_soa as an independent maintenance schedule T2.1
D5 p28, Table 2 (continued) "Table 2 (continued)" (V20–V29, p28–32) treated as the second column tile of one tiled Table 2; rows unioned by name, marks merged; redacted "CCI" rows matched across tiles by position between the same neighbours Separate continuation table, or a different matching of the redacted rows T2.2
D6 p24/p28, Table 2 Visit number row, markers t5/t6 (and t2/t3) Remote-visit note bound to the visit cells it names (V10–V19 tile 1 as t5; V20–V28 tile 2 as t6, V29 excluded). Tile variants that differ in wording/punctuation kept as separate notes (remote note: one comma; ETV cross-reference: "an ETV" vs "an early termination visit") Merge the variant pairs, and/or bind to the whole Visit number row T2.5
D7 p27, Table 2 "Endoscopic Procedure" header, marker c30 Comment "Not applicable for responders during the time period of V10 through V19" bound to the section-header row (governs the group) Bind to the Endoscopy and Colon biopsy rows, or to the V10–V19 columns T2.5
D8 p33, Table 3 Typed track, track_label "Nonresponders" (applies only to nonresponders at Week 12) despite identical V10–V29 numbering to Table 2 domain of Table 2 or main_soa T3.1
D9 p38, Table 3 (continued) "Table 3 (continued)" (V20–V29, p38–42) treated as tile 2 of one tiled Table 3; rows unioned; "CCI" rows matched by position Separate continuation table / different matching T3.2
D10 p33/p38, Table 3 Visit number row, markers t5/t6/t7 "Visits 17 through 28…" note bound to V17–V19 (t5) and V20–V28 (t6, tile-2 text lacks final period); "V16 procedures…" note bound to the V16 cell (t7) Table-wide notes on the Visit number row; merge the two remote-visit variants T3.5
D11 p43, Table 4 Typed main_soa (independent schedule, own columns ETV/V997/V801/V802, applies to all participants) track (e.g. "Follow-Up") as a separate study-phase timeline T4.1
D12 p43, Table 4 Visit number row, markers t1/t2 "V802 is only for randomized participants who were positive for anti-HBc…" bound to the V802 cell; "V997: Additional study procedures…" bound to the V997 cell Table-wide notes on the Visit number row T4.5
D13 p43, Table 4 Vital signs, marker c4 Vital-signs comment (ending "V997: Vital signs collection is optional.") kept as one footnote on the row Split the V997 sentence into a note on the Vital signs × V997 cell T4.5

Recorded, not open (8)

Method (all tables)

Table 1 — Screening and Induction (doc 17–23)

Table 2 — Maintenance, responders (doc 24–32)

Table 3 — Extension Induction / Extension Maintenance, nonresponders (doc 33–42)

Table 4 — ETV, unscheduled, post-treatment follow-up (doc 43–46)

Annotation text integrity

Orphan risk

Method provenance