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All patients with a positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment should continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 18, "column_position": 2 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 19, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 19, "column_position": 5 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 20, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 20, "column_position": 5 } ] }, { "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 19, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 19, "column_position": 5 } ] }, { "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNA-PCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be discontinued if HCV flare is confirmed according to the guidance in Table 5-5.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 20, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 20, "column_position": 5 } ] }, { "annotation_marker": "i", "annotation_type": "footnote", "annotation_text": "Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week (every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be repeated once disease progression is documented.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 2 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 6 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 7 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 9 } ] }, { "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last dose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 10, "column_position": 7 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 10, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 10, "column_position": 9 } ] }, { "annotation_marker": "k", "annotation_type": "footnote", "annotation_text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 14, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 15, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 16, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 17, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 19, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 20, "column_position": 8 } ] }, { "annotation_marker": "l", "annotation_type": "footnote", "annotation_text": "Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 21, "column_position": 8 } ] }, { "annotation_marker": "m", "annotation_type": "footnote", "annotation_text": "All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed during the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented progression.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 9 } ] }, { "annotation_marker": "n", "annotation_type": "footnote", "annotation_text": "PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 22 } ] }, { "annotation_marker": "o", "annotation_type": "footnote", "annotation_text": "Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 9 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 11, "column_position": 9 } ] }, { "annotation_marker": "*", "annotation_type": "footnote", "annotation_text": "Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15 of the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 2, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 2, "column_position": 5 } ] }, { "annotation_marker": "^", "annotation_type": "footnote", "annotation_text": "End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 7 } ] }, { "annotation_marker": "£", "annotation_type": "footnote", "annotation_text": "Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination with everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 8 } ] }, { "annotation_marker": "tb1", "annotation_type": "footnote", "annotation_text": "TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION", "marker_locations": [ { "table_number": 1, "location_type": "schedule_property", "row_position": 1, "method": "synthesized" } ] }, { "annotation_marker": "pr1", "annotation_type": "source_note", "annotation_text": "see Appendix C", "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 7, "method": "synthesized" } ] }, { "annotation_marker": "pr2", "annotation_type": "source_note", "annotation_text": "Section 5.6", "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 7, "method": "synthesized" } ] } ], "review_items": [ { "id": "D1", "severity": "medium", "location": { "page": 69, "row_position": 1, "annotation_marker": "tb1" }, "call_made": "The bold banner above the table, 'TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION', is kept as a footnote (synthesized marker tb1) attached to the Phase header row.", "alternative": "Treat the banner as part of the table title only, or drop it as a non-table heading.", "report_section": "3.1" }, { "id": "D2", "severity": "medium", "location": { "page": 69, "row_positions": [ 1, 2 ] }, "call_made": "Header cells for columns 7-9 (End of Induction/End of Treatment, Continuation Phase, Follow-Up Off Therapy) are printed as one tall cell covering both header rows; their text is recorded once in row 1 (Phase) and the row-2 (Visit) cells are left empty.", "alternative": "Repeat the same text in row 2 as well, so every column has a Visit label.", "report_section": "3.1" }, { "id": "D3", "severity": "medium", "location": { "page": 69, "row_position": 1, "column_position": 7 }, "call_made": "Row 1 is typed epoch although its column-7 value (End of Induction Phase End of Treatment) is an end-of-phase visit rather than a phase.", "alternative": "Type row 1 as other, or model column 7's header as a visit.", "report_section": "3.1" }, { "id": "D4", "severity": "medium", "location": { "page": 69, "row_position": 8, "column_position": 2 }, "call_made": "The Pre-Study cell of Vital Signs is kept literally as 'X (includes Ht)' (qualifier kept inside the mark).", "alternative": "Record the mark as 'X' and move '(includes Ht)' into a separate note.", "report_section": "3.2" }, { "id": "D5", "severity": "medium", "location": { "page": 69, "row_position": 1, "column_position": 7, "annotation_marker": "pr2" }, "call_made": "'Section 5.6' printed under 'End of Treatment' in the column-7 header is removed from the header label and recorded as a cross-reference note (pr2) on that header cell.", "alternative": "Keep 'Section 5.6' as part of the header label text.", "report_section": "3.3" }, { "id": "D6", "severity": "low", "location": { "page": 71 }, "call_made": "The table's page range is 69-71 because footnotes k-o, *, ^ and £ print on page 71, which carries no activity rows.", "alternative": "Declare the table as pages 69-70 (the pages with grid rows only).", "report_section": "3.1" } ] }