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Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria²⁰) and other sample testing results related to MDS/AML.", "display_markers": "T1:28, T2:15", "source_occurrences": [ { "table_num": 1, "marker": "28", "annotation_id": "annot-028" }, { "table_num": 2, "marker": "15", "annotation_id": "annot-013" } ], "referenced_xacts": [ "xact-028" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-028", "xcol_id": "xcol-002" }, { "xact_id": "xact-028", "xcol_id": "xcol-003" }, { "xact_id": "xact-028", "xcol_id": "xcol-004" }, { "xact_id": "xact-028", "xcol_id": "xcol-005" }, { "xact_id": "xact-028", "xcol_id": "xcol-006" }, { "xact_id": "xact-028", "xcol_id": "xcol-007" }, { "xact_id": "xact-028", "xcol_id": "xcol-008" }, { "xact_id": "xact-028", "xcol_id": "xcol-009" }, { "xact_id": "xact-028", "xcol_id": "xcol-011" }, { "xact_id": "xact-028", "xcol_id": "xcol-012" }, { "xact_id": "xact-028", "xcol_id": "xcol-013" }, { "xact_id": "xact-028", "xcol_id": "xcol-014" }, { "xact_id": "xact-028", "xcol_id": "xcol-015" }, { "xact_id": "xact-028", "xcol_id": "xcol-016" }, { "xact_id": "xact-028", "xcol_id": "xcol-017" } ], "occurrence_count": 2 }, { "xannot_id": "xannot-029", "annotation_type": "footnote", "annotation_text": "Negative serum pregnancy test required within 72 hours prior to study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).", "display_markers": "T2:3", "source_occurrences": [ { "table_num": 2, "marker": "3", "annotation_id": "annot-003" } ], "referenced_xacts": [ "xact-007" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-007", "xcol_id": "xcol-010" }, { "xact_id": "xact-007", "xcol_id": "xcol-013" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-030", "annotation_type": "footnote", "annotation_text": "Patients will be randomized in a crossover design within 72 hours prior to FE Day 1 (first single dose).", "display_markers": "T2:4", "source_occurrences": [ { "table_num": 2, "marker": "4", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-008" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-008", "xcol_id": "xcol-010" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-031", "annotation_type": "footnote", "annotation_text": "Patients receive a single oral dose of niraparib 300 mg on FE Days 1 and 8.", "display_markers": "T2:5", "source_occurrences": [ { "table_num": 2, "marker": "5", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-025" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-025", "xcol_id": "xcol-011" }, { "xact_id": "xact-025", "xcol_id": "xcol-012" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-032", "annotation_type": "footnote", "annotation_text": "No new capsules dispensed.", "display_markers": "T2:6", "source_occurrences": [ { "table_num": 2, "marker": "6", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-025" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-025", "xcol_id": "xcol-017" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-033", "annotation_type": "footnote", "annotation_text": "Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen and bilirubin.", "display_markers": "T2:8", "source_occurrences": [ { "table_num": 2, "marker": "8", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-017" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-034", "annotation_type": "footnote", "annotation_text": "12-lead ECG at Screening, Cycle 1/Day 1 (predose and 2 hours postdose), Cycle 2/Day 1 (predose and 2 hours postdose), and at treatment discontinuation. ECG monitoring is to be performed prior to PK blood draws.", "display_markers": "T2:9", "source_occurrences": [ { "table_num": 2, "marker": "9", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-018" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-035", "annotation_type": "footnote", "annotation_text": "Triplicate ECG monitoring to coincide with PK on FE Days 1 and 8 at baseline (predose) and at 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.", "display_markers": "T2:10", "source_occurrences": [ { "table_num": 2, "marker": "10", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-018" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-018", "xcol_id": "xcol-011" }, { "xact_id": "xact-018", "xcol_id": "xcol-012" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-036", "annotation_type": "footnote", "annotation_text": "Blood samples for PK will be taken on FE Days 1 and 8 at baseline (within 30 minutes prior to dosing) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose. Additional blood samples will be collected predose and 2 hours postdose on Day 1 of Cycles 1 and 2 and predose only on Day 1 of Cycles 4 and 8. The exact time of the PK blood draw will be recorded and PK blood draws are to be completed after ECG monitoring.", "display_markers": "T2:11", "source_occurrences": [ { "table_num": 2, "marker": "11", "annotation_id": "annot-011" } ], "referenced_xacts": [ "xact-021" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-037", "annotation_type": "footnote", "annotation_text": "Note: Patients in food effect sub-study will receive a single oral dose of niraparib 300 mg on FE Days 1 and 8. Upon completion of the 14-day sub-study, patients will then start open-label treatment with daily niraparib (300 mg QD) on Day 1/Cycle 1 (approximately 2 weeks after start of food effect sub-study) and will be followed using the main study visit schedule for safety.", "display_markers": "T2:n1", "source_occurrences": [ { "table_num": 2, "marker": "n1", "annotation_id": "annot-014" } ], "referenced_xacts": [], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "annotation_scope": "table" }, { "xannot_id": "xannot-038", "annotation_type": "footnote", "annotation_text": "During the in-clinic visit extended cycle, all study procedures and assessments required will be performed.", "display_markers": "T3:1", "source_occurrences": [ { "table_num": 3, "marker": "1", "annotation_id": "annot-001" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-018" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-039", "annotation_type": "footnote", "annotation_text": "The study coordinator will contact the patient by telephone to obtain information for the ECOG performance status, adverse event monitoring, and concomitant medications when the study assessments are not performed in clinic.", "display_markers": "T3:2", "source_occurrences": [ { "table_num": 3, "marker": "2", "annotation_id": "annot-002" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-019" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-040", "annotation_type": "footnote", "annotation_text": "The collection of blood samples for CBC and chemistry analysis, vital signs and weight may be collected during visit to local clinic or at in-home nursing visit when the study assessments are not performed in clinic.", "display_markers": "T3:3", "source_occurrences": [ { "table_num": 3, "marker": "3", "annotation_id": "annot-003" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-020" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-041", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3); no confident Table 7 (Main Study) equivalent for this Vital signs cell in the 'Patient Visit to Local Clinic or In-Home Nursing' column. Clinical review 2026-08-15: remains unresolved — no Table 7 candidate (Table 7's vital-signs footnote is \"Height obtained at screening only\"); §7.4.1 confirms vital signs at the local clinic/in-home nursing visit, content already covered by printed footnote 3.", "display_markers": "T3:4", "source_occurrences": [ { "table_num": 3, "marker": "4", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-010" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-010", "xcol_id": "xcol-020" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-042", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 10: \"SAEs recorded up to 30 days after study treatment discontinuation.\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists \"AEs (SAEs recorded 30 days post study treatment discontinuation)\".", "display_markers": "T3:5", "source_occurrences": [ { "table_num": 3, "marker": "5", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-012" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-012", "xcol_id": "xcol-021" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-043", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 12: \"If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the adverse event resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also be required for an additional 4 weeks after the adverse event has been resolved to the specified levels, after which monitoring every 4 weeks may resume.\" Clinical review 2026-08-15: hypothesis retained; §7.4 does not restate this rule.", "display_markers": "T3:6", "source_occurrences": [ { "table_num": 3, "marker": "6", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-015" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-044", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 13: \"CA-125 levels must be normal at screening or > 90% decrease as compared with baseline prior to last platinum-based chemotherapy course. Abnormal CA-125 levels during study do not represent disease progression; however, they may prompt imaging if clinically indicated. CA-125 sample within 72 hours of dose on Cycle 1/Day 1.\" Clinical review 2026-08-15: hypothesis retained; note the screening and Cycle 1/Day 1 clauses of footnote 13 are phase-specific and may not apply in extended cycles; §7.4 is silent on CA-125 rules.", "display_markers": "T3:7", "source_occurrences": [ { "table_num": 3, "marker": "7", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-016" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-045", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 14: \"For determination of CA-125 progression, at least 2 CA-125 values at least 1 week apart are required for confirmation (Section 6.1).\" Clinical review 2026-08-15: hypothesis retained; content is phase-independent; §7.4 does not restate it.", "display_markers": "T3:8", "source_occurrences": [ { "table_num": 3, "marker": "8", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-016" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-046", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 16: \"Patients will have a 12-lead ECG at Screening, Baseline (predose, within 30 minutes), 2 hours postdose on Day 1(within 30 minutes), Cycle 2/Day 1, (predose, 2 hours postdose, within 30 minutes) and upon study treatment discontinuation. Note that the ECG is to be completed prior to the PK blood draw.\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists 12-lead ECG at study treatment discontinuation — the only ECG mark in this table; the screening/PK clauses of footnote 16 do not apply in extended cycles.", "display_markers": "T3:9", "source_occurrences": [ { "table_num": 3, "marker": "9", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-018" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-047", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 22: \"RECIST tumor assessment via CT or MRI scan of abdomen/pelvis and clinically indicated areas required at baseline, then after every 2 cycles (ie, 8 weeks with a window of ± 7 days from date of visit) through Cycle 14 (56 weeks), then after every 6 cycles (24 weeks with a window of ± 7 days) until study treatment discontinuation; at this point, a final follow-up set of imaging is required. PET/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for clinical progression and does not meet the criteria specified in the protocol, scans and CA-125 testing should continue at the specified intervals until progression is confirmed or until the start of subsequent anticancer treatment.\" NOTE (clinical review 2026-08-15): §7.4.2 states RECIST \"after every 2 cycles through Cycle 14 and then after every 3 cycles\", which conflicts with footnote 22's post-Cycle-14 cadence of every 6 cycles (24 weeks) — a source-internal contradiction, left unresolved; hypothesis retained.", "display_markers": "T3:10", "source_occurrences": [ { "table_num": 3, "marker": "10", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-022" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-048", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 24: \"PROs (FOSI, EQ-5D-5L, neuropathy questionnaire) will be collected while on study treatment every 8 weeks through the first year, then every 12 weeks thereafter. If the patient discontinues study treatment, assessment will occur at that time and then 8 weeks (± 2 weeks) later, regardless of status of subsequent treatment. PROs should be administered before conducting any other procedures.\" Mapping confirmed by clinical review (2026-08-15): §7.4.2 states PROs every 3 cycles (= every 12 weeks, matching footnote 24) and repeats \"PROs should be administered before conducting any other procedures\" verbatim; §7.4.4 matches the 8 (± 2) weeks post-discontinuation assessment.", "display_markers": "T3:11", "source_occurrences": [ { "table_num": 3, "marker": "11", "annotation_id": "annot-011" } ], "referenced_xacts": [ "xact-024" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-049", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 25: \"No new capsules dispensed\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists \"Study treatment capsules collected\" (no dispensing) at discontinuation.", "display_markers": "T3:12", "source_occurrences": [ { "table_num": 3, "marker": "12", "annotation_id": "annot-012" } ], "referenced_xacts": [ "xact-025" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-025", "xcol_id": "xcol-021" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-050", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 26: \"Every 90 days following study treatment discontinuation.\" Mapping confirmed by clinical review (2026-08-15): §7.4.4: \"Assessment of next subsequent anticancer therapies will be assessed every 90 days (± 28 days) following study treatment discontinuation visit.\"", "display_markers": "T3:13", "source_occurrences": [ { "table_num": 3, "marker": "13", "annotation_id": "annot-013" } ], "referenced_xacts": [ "xact-031" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-031", "xcol_id": "xcol-022" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-051", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 27: \"In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information.\" Mapping confirmed by clinical review (2026-08-15): §7.4.4: survival status every 90 days (± 28 days) post-discontinuation; \"New malignancy information will also be collected as part of this assessment.\"", "display_markers": "T3:14", "source_occurrences": [ { "table_num": 3, "marker": "14", "annotation_id": "annot-014" } ], "referenced_xacts": [ "xact-027" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-052", "annotation_type": "footnote", "annotation_text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 28: \"For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria) and other sample testing results related to MDS/AML.\" Mapping confirmed by clinical review (2026-08-15): §7.4.5 (Unscheduled Assessments) reproduces this text verbatim.", "display_markers": "T3:15", "source_occurrences": [ { "table_num": 3, "marker": "15", "annotation_id": "annot-015" } ], "referenced_xacts": [ "xact-028" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-028", "xcol_id": "xcol-018" }, { "xact_id": "xact-028", "xcol_id": "xcol-019" }, { "xact_id": "xact-028", "xcol_id": "xcol-020" }, { "xact_id": "xact-028", "xcol_id": "xcol-021" }, { "xact_id": "xact-028", "xcol_id": "xcol-022" } ], "occurrence_count": 1 } ], "review_items": [ { "table_number": 1, "id": "D1", "severity": "medium", "location": { "page": 63, "row_position": 1 }, "call_made": "The top header row labelled 'Cycle' is typed as a cycle row (printed Table 7, row 1; the same call is made for printed Table 9, row 1, also labelled 'Cycle').", "alternative": "Type these rows as epoch rows, because they also carry study phases (Screening, Study Treatment Discontinuation, Post Treatment Assessments) rather than only numbered cycles.", "report_section": "2.3" }, { "table_number": 1, "id": "D2", "severity": "medium", "location": { "page": 66, "row_position": 30 }, "call_made": "'Bone marrow aspirate and biopsy' is a top-level activity (indentation 0) like every other row; its one leading space in the source cell is treated as a typing artefact.", "alternative": "Treat the leading space as indentation, making the row a child (level 1) of the row above it ('Survival assessment').", "report_section": "2.3" }, { "table_number": 2, "id": "D3", "severity": "medium", "location": { "page": 72 }, "call_made": "Printed Table 8 is typed as a separate track ('Food Effect Sub-Study'): it schedules the food-effect sub-study patients on their own visits (FE Day 1, FE Day 8).", "alternative": "Type it main_soa, as an independent schedule table of its own, without a track label.", "report_section": "3.1" }, { "table_number": 2, "id": "D4", "severity": "low", "location": { "page": 73, "row_position": 1, "annotation_marker": "12" }, "call_made": "On the reprinted header of page 73 the footnotes on 'Cycle' and 'Subsequent Cycles' are renumbered 12 and 13; their text is identical to footnotes 1 and 2, so the reprinted header is de-duplicated and 12/13 are not emitted as separate notes.", "alternative": "Emit footnotes 12 and 13 as their own notes on the same header cells, in addition to 1 and 2.", "report_section": "3.4" }, { "table_number": 2, "id": "D5", "severity": "high", "location": { "page": 73, "row_position": 1, "annotation_marker": "n1" }, "call_made": "The full-width 'Note: Patients in food effect sub-study ...' row at the foot of the page-73 table is not an activity; it is kept as one footnote (synthesised marker n1) applying to the whole table, anchored on header row 1.", "alternative": "Bind the note to specific rows (e.g. study treatment dispensed/collected) or leave its scope unresolved.", "report_section": "3.3" }, { "table_number": 3, "id": "D6", "severity": "medium", "location": { "page": 78 }, "call_made": "Printed Table 9 (Main Study – Extended Visit Cycle) is typed as a separate track ('Extended Visit Cycle'): main-study patients in a later phase follow an alternative visit pattern (in-clinic extended cycle, telephone contact, local clinic / in-home nursing).", "alternative": "Type it main_soa as an independent schedule, or subsidiary to Table 7's 'Subsequent Cycles' column.", "report_section": "4.1" }, { "table_number": 3, "id": "D7", "severity": "medium", "location": { "page": 78, "row_positions": [ 5, 7, 10, 11, 12, 13, 14, 15, 16, 17, 18 ] }, "call_made": "Footnote markers 4-15 of printed Table 9 have no text in the excerpt; each is kept as a note saying the definition is not printed, with a clearly-labelled probable equivalent from Table 7 where one exists.", "alternative": "State only that the definition is not printed, with no Table 7 cross-reference.", "report_section": "4.3" } ] }