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"Patients who experience PD during or at the end of the Induction Treatment Phase, or who refuse to go into the Maintenance Treatment Phase or who are not eligible for any study cohort, will undergo a Study Treatment Discontinuation Visit within 30 days after the last dose of study medication. These patients will then enter the Post-Treatment Follow-up Phase. All patients need to be evaluated for potential resection of metastasis at completion of the induction period. This is of particular importance for patients with liver metastases. If the patient is found to be resectable they will undergo a Study Treatment Discontinuation Visit within 30 days after the last dose of study treatment and will then enter the Post-Treatment Follow-up Phase.", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-006" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 2, "column_position": 6 } ] }, { "annotation_id": "annot-003", "table_id": "table-001", "annotation_marker": "c", "annotation_type": "footnote", "annotation_text": "Patients in the Post-Treatment Follow-up Phase will be followed up every 3 months after their Study Treatment Discontinuation Visit. During post-treatment follow-up subsequent anti-cancer therapies will be recorded and survival assessed up to May 31, 2019 only. Refer to Appendix 19 for management of patients based on their study status on May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion; BRAFmut/MSS patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib; BRAFmut/MSI-H patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab and atezolizumab. See Section 3.1.1.1 for further details including if disease progression occurs prior to availability of study biomarker test results in a patient with a previous BRAF mutation-positive result (e.g. by local test). Patients who discontinue study treatment during the Induction Treatment Phase prior to disease progression will also continue to be followed for PFS, with disease status followed according to local practice until progression or May 31, 2019, whichever comes first. Disease status will not be collected for the study after May 31, 2019.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [ "col-007" ], "activity_ids": [ "act-020", "act-021" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 2, "column_position": 7 }, { "table_number": 1, "location_type": "activity_name", "row_position": 23 }, { "table_number": 1, "location_type": "activity_name", "row_position": 24 } ], "document_references": [ { "kind": "section", "target": "3.1.1.1" }, { "kind": "appendix", "target": "19" } ] }, { "annotation_id": "annot-004", "table_id": "table-001", "annotation_marker": "d", "annotation_type": "footnote", "annotation_text": "Written informed consent for participation in the study must be obtained before performing any study-specific screening tests or evaluations and before shipping primary tumour blocks or slides to the Sponsor-designated laboratory. However, results from routine assessments conducted prior to informed consent signature may be used as screening assessments as long as they were done within 7 days prior to informed consent signature.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-001" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 4 } ] }, { "annotation_id": "annot-005", "table_id": "table-001", "annotation_marker": "e", "annotation_type": "footnote", "annotation_text": "The “All Cohort” eligibility criteria are evaluated prior to initiating the first cycle of study treatment during the Induction Treatment Phase.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-002" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 5 } ] }, { "annotation_id": "annot-006", "table_id": "table-001", "annotation_marker": "f", "annotation_type": "footnote", "annotation_text": "Medical history includes clinically significant diseases, surgeries, cancer history (including prior cancer therapies and procedures), reproductive status, smoking history, use of alcohol and drugs of abuse, and all medications (e.g., prescription drugs, over-the-counter drugs, herbal or homeopathic remedies, nutritional supplements) used by the patient within 7 days prior to the Screening visit. Demographic data will include age, sex, and self-reported race/ethnicity (where permitted by federal regulations).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-003" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 6 } ] }, { "annotation_id": "annot-007", "table_id": "table-001", "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. During Screening, weight only required ≤ 7 days.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-004" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 7 } ] }, { "annotation_id": "annot-008", "table_id": "table-001", "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "Baseline assessment requires a complete physical exam. A complete physical examination should include an evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Abnormalities identified at Screening / Baseline will be recorded as baseline conditions. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed. Changes from Baseline, with new or worsened clinically significant abnormalities, should be reported as AEs if appropriate.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-005" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 8 } ] }, { "annotation_id": "annot-009", "table_id": "table-001", "annotation_marker": "i", "annotation_type": "footnote", "annotation_text": "ECOG status assessed within 7 days prior to Day 1 of Cycle 1 (Induction Treatment Phase) for eligibility determination. See Appendix 8.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-006" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 9 } ], "document_references": [ { "kind": "appendix", "target": "8" } ] }, { "annotation_id": "annot-010", "table_id": "table-001", "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "Concomitant medication includes any prescription medications or over-the-counter preparations used by a patient between the 7 days prior to the date of informed consent up until the date of study discontinuation. Only concomitant medications used for supportive care, to alleviate symptoms of mCRC, or to treat adverse drug reactions should be recorded on the Concomitant Medications eCRF. At subsequent visits, only changes to current medications or medications used since the last documentation of medications will be recorded. Concomitant medications for treatment of AEs related to study medication will continue to be recorded while the AE is being followed. For permitted and prohibited concomitant medications, see Section 4.4.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-007" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 10 } ], "document_references": [ { "kind": "section", "target": "4.4" } ] }, { "annotation_id": "annot-011", "table_id": "table-001", "annotation_marker": "k", "annotation_type": "footnote", "annotation_text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride, and bicarbonate. Hematology and blood chemistry tests must be conducted prior to each treatment cycle, with the results available for review prior to start of treatment according to local standards for treatment management. However, only tests conducted every second treatment cycle will be recorded in the eCRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-008" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 11 } ] }, { "annotation_id": "annot-012", "table_id": "table-001", "annotation_marker": "l", "annotation_type": "footnote", "annotation_text": "INR and aPTT are required for all patients at screening but only for patients receiving anticoagulants while on protocol-specified treatment.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-009" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 12 } ] }, { "annotation_id": "annot-013", "table_id": "table-001", "annotation_marker": "m", "annotation_type": "footnote", "annotation_text": "Urinalysis must be performed by dipstick at Baseline and within 48 hours prior to every cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-010" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 13 } ] }, { "annotation_id": "annot-014", "table_id": "table-001", "annotation_marker": "n", "annotation_type": "footnote", "annotation_text": "Urine or blood pregnancy test, only for women of childbearing potential (i.e. not post-menopausal as indicated by < 12 months of non-therapy-induced amenorrhea, nor surgically sterile [absence of ovaries and/or uterus]), including those who have had a tubal ligation. A serum pregnancy test is required within 7 days prior to start of study induction treatment, or within 14 days with a confirmatory urine pregnancy test within 7 days prior start of study induction treatment", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-011" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 14, "method": "synthesized" } ] }, { "annotation_id": "annot-015", "table_id": "table-001", "annotation_marker": "o", "annotation_type": "footnote", "annotation_text": "Will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. Include upper abdomen at Baseline. A CT or MRI scan of the brain is required if there is clinical suspicion of CNS metastases at screening/Baseline or at any time during the Induction Treatment Phase. Subsequent tumour assessments will be done according to standard of care at each study centre, with the exception that all patients must have a tumour assessment at the end of the Induction Treatment Phase. Tumour assessments are not required for study purposes after disease progression has been documented. Patients who discontinue study treatment during the Induction Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease status followed according to local practice until progression or May 31, 2019, whichever comes first. After May 31, 2019, disease status will not be collected for the study.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-012" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 15 } ] }, { "annotation_id": "annot-016", "table_id": "table-001", "annotation_marker": "p", "annotation_type": "footnote", "annotation_text": "Archival tumour tissue (FFPET) block from the primary tumour obtained at the time of the initial diagnosis. If the tumour block is not available, ≥ 20 slides cut from the primary tumour sample will be accepted as an alternative. Before a patient can be enrolled, the sample (block or slides) must be shipped to the designated laboratory with the corresponding pathology report and receipt of the shipment must be confirmed by the laboratory. See Appendix 17.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-013" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 16 } ], "document_references": [ { "kind": "appendix", "target": "17" } ] }, { "annotation_id": "annot-017", "table_id": "table-001", "annotation_marker": "q", "annotation_type": "footnote", "annotation_text": "Collection of the optional core biopsy of metastatic tumours was discontinued as of May 2018. (See Appendix 18).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-014" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 17 } ], "document_references": [ { "kind": "appendix", "target": "18" } ] }, { "annotation_id": "annot-018", "table_id": "table-001", "annotation_marker": "r", "annotation_type": "footnote", "annotation_text": "Whole blood and plasma samples will be collected from all study patients for exploratory biomarker analyses unless genomic analysis is not allowed per local regulations. In such instances, only plasma samples will be collected. All samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment Day 1 of each cycle indicated, unless otherwise specified (see Appendix 17 and Laboratory Manual).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-015", "act-016" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 18 }, { "table_number": 1, "location_type": "activity_name", "row_position": 19 } ], "document_references": [ { "kind": "appendix", "target": "17" } ] }, { "annotation_id": "annot-019", "table_id": "table-001", "annotation_marker": "s", "annotation_type": "footnote", "annotation_text": "After the signing of the informed consent form, and prior to Day 1 of Cycle 1 (Induction Treatment Phase), any SAEs thought to be related to a protocol-mandated intervention should be reported. Adverse events will be documented at every cycle during treatment. All patients will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-018" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 21 } ] }, { "annotation_id": "annot-020", "table_id": "table-001", "annotation_marker": "t", "annotation_type": "footnote", "annotation_text": "Eligible patients will enter a 4-month Induction Treatment Phase. Treatment during this phase, based on Investigator’s choice, will be either eight 2-week cycles of 5-FU, LV and oxaliplatin (FOLFOX) in combination with bevacizumab or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-019" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 22 } ] }, { "annotation_id": "annot-021", "table_id": "table-001", "annotation_marker": "n1", "annotation_type": "footnote", "annotation_text": "Collection of these samples discontinued as of May 2018", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-014" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 17, "method": "synthesized" } ] }, { "annotation_id": "annot-022", "table_id": "table-001", "annotation_marker": "n2", "annotation_type": "footnote", "annotation_text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-017" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 20, "method": "synthesized" } ] }, { "annotation_id": "annot-023", "table_id": "table-001", "annotation_marker": "pr1", "annotation_type": "source_note", "annotation_text": "See Appendix 19", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-007" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 3, "column_position": 7, "method": "synthesized" } ], "document_references": [ { "kind": "appendix", "target": "19" } ] } ], "review_items": [ { "id": "D1", "severity": "medium", "location": { "page": 170, "row_positions": [ 17, 20 ], "annotation_marker": "n1" }, "call_made": "Explanatory sub-lines printed inside an activity label cell (e.g. \"Collection of these samples discontinued as of May 2018\" under Metastatic tumour tissue; the Supplemental Biomarker Program closure sentence under Stool sample; \"(Experimental Arm only)\" under several Cohort 1/2/4 activities) were moved out of activity_name into footnote annotations with synthesised markers n1/n2 bound to that activity. The full raw text stays in activity_name_source.cell_text. Applies to Tables 1, 2, 3, 4 and 5.", "alternative": "Keep the sub-line as part of activity_name (e.g. \"Pulse oximetry (Experimental Arm only)\"), producing no synthesised annotation.", "report_section": "3.3" }, { "id": "D2", "severity": "medium", "location": { "page": 169, "row_position": 3 }, "call_made": "The second/third header row carrying per-column timing descriptors (\"≤ 28 days\", \"Day 1 Cycle 1\", \"Every 2 cycles (every 4 weeks)\", \"(≤ 30 days after last dose ...)\", \"Every 3 months ...\") is typed property_type \"other\" in every table, because it mixes windows, anchors and recurrence frequencies.", "alternative": "Type the row as \"visit\" (each column is one visit/encounter) or as \"window\".", "report_section": "3.2" } ] }