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If a patient experiences any Grade 3 IRRs during any SDI administrations of obinutuzumab (i.e. after Cycle 1, Day 1), the next dose of obinutuzumab will be administered at the regular infusion rate. If the patient experiences a second occurrence of a Grade 3 IRR, the obinutuzumab infusion must be stopped and the therapy must be permanently discontinued.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-021", "column_id": "col-007" }, { "activity_id": "act-021", "column_id": "col-008" }, { "activity_id": "act-021", "column_id": "col-010" } ] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 25, "column_position": 7 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 25, "column_position": 8 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 25, "column_position": 10 } ], "document_references": [ { "kind": "section", "target": "3.1" }, { "kind": "table", "target": "1" } ] }, { "annotation_id": "annot-006", "table_id": "table-001", "annotation_marker": "e", "annotation_type": "footnote", "annotation_text": "Patients who achieve at least a partial response (PR) following the completion of induction therapy will receive obinutuzumab maintenance therapy (1000 mg as single agent every 8 weeks (± 10 days) for 2 years or until disease progression). The first administration of obinutuzumab maintenance therapy is expected to start 8 weeks ± 10 days from Day 1 of the last induction cycle. Patients with stable disease or progressive disease will go to safety follow-up. For the timing of the safety follow-up assessment, please see footnote aa.", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-010" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 2, "column_position": 10 } ] }, { "annotation_id": "annot-007", "table_id": "table-001", "annotation_marker": "f", "annotation_type": "footnote", "annotation_text": "Informed consent must be documented before any study-specific screening procedure is performed, and may be obtained more than 28 days before initiation of study treatment.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-001", "column_id": "col-002" } ] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 5, "column_position": 2 } ] }, { "annotation_id": "annot-008", "table_id": "table-001", "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Includes blood pressure, pulse rate and temperature. Record abnormalities observed at baseline on the General Medical History and Baseline Conditions eCRF. At subsequent visits, record new or worsened clinically significant abnormalities on the Adverse Event eCRF.", "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": 10 } ] }, { "annotation_id": "annot-009", "table_id": "table-001", "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "Includes evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatologic, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurologic systems. Record abnormalities observed at baseline on the General Medical History and Baseline Conditions eCRF. At subsequent visits, record new or worsened clinically significant abnormalities on the Adverse Event eCRF.", "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": 15 } ] }, { "annotation_id": "annot-010", "table_id": "table-001", "annotation_marker": "i", "annotation_type": "footnote", "annotation_text": "As part of tumor assessment, the physical examination should include evaluation for the presence of enlarged nodes, palpable hepatomegaly, and splenomegaly. This information will be recorded on the appropriate tumor assessment eCRF.", "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": 15 } ] }, { "annotation_id": "annot-011", "table_id": "table-001", "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "Includes systems of primary relevance (e.g., cardiovascular and respiratory systems), systems associated with symptoms (newly emergent or monitored from baseline), and areas associated with tumor assessment (lymph nodes, liver, spleen, and any other areas identified at baseline). Record new or worsened clinically significant abnormalities on the Adverse Event eCRF.", "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": 16 } ] }, { "annotation_id": "annot-012", "table_id": "table-001", "annotation_marker": "k", "annotation_type": "footnote", "annotation_text": "Perform at the same time as tumor assessments after the end of induction treatment.", "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": 16 } ] }, { "annotation_id": "annot-013", "table_id": "table-001", "annotation_marker": "l", "annotation_type": "footnote", "annotation_text": "Unexplained fever >38ºC, night sweats, unexplained weight loss >10% of body weight over 6 months.", "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": 17 } ] }, { "annotation_id": "annot-014", "table_id": "table-001", "annotation_marker": "m", "annotation_type": "footnote", "annotation_text": "Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, other cells).", "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": 18 } ] }, { "annotation_id": "annot-015", "table_id": "table-001", "annotation_marker": "n", "annotation_type": "footnote", "annotation_text": "Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphate, calcium, total and direct bilirubin, ALP, ALT, AST, urate, beta-2 microglobulin (at screening and EOI only) and LDH.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-015" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 19 } ] }, { "annotation_id": "annot-016", "table_id": "table-001", "annotation_marker": "o", "annotation_type": "footnote", "annotation_text": "All women of childbearing potential will have a serum pregnancy test at screening.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-016" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 20 } ] }, { "annotation_id": "annot-017", "table_id": "table-001", "annotation_marker": "p", "annotation_type": "footnote", "annotation_text": "Includes dipstick (pH, specific gravity, glucose, protein, ketones, blood) and microscopic examination if routinely performed (sediment, RBCs, WBCs, casts, crystals, epithelial cells, bacteria).", "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": 22 } ] }, { "annotation_id": "annot-018", "table_id": "table-001", "annotation_marker": "q", "annotation_type": "footnote", "annotation_text": "To include assessment of HBV/HCV DNA PCR in patients with resolved HBV/HCV infection at baseline. HBV DNA PCR testing at least every 3 months should also be conducted (during the study and for at least 1 year after completion of lymphoma treatment) for patients with prior HBV infection or who are carriers of HBV. HTLV-1 testing will be performed at baseline in patients from endemic countries only. HIV testing will be performed at baseline if required by local regulations.", "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": 23 } ] }, { "annotation_id": "annot-019", "table_id": "table-001", "annotation_marker": "r", "annotation_type": "footnote", "annotation_text": "Obinutuzumab administered on Days, 1, 8 and 15 of cycle 1 and Day 1 of subsequent cycles.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-021" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 25 } ] }, { "annotation_id": "annot-020", "table_id": "table-001", "annotation_marker": "s", "annotation_type": "footnote", "annotation_text": "Chemotherapy comprises either bendamustine (Days 1 and 2, Cycles 1–6; 28-day cycles), CHOP (Days 1–5, Cycles 1–6; 21-day cycles; followed by 2 cycles of obinutuzumab alone), or CVP (Days 1–5, Cycles 1–8; 21-day cycles). See Section 4.3.2.2 Combination chemotherapy.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-022" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 26 } ], "document_references": [ { "kind": "section", "target": "4.3.2.2" } ] }, { "annotation_id": "annot-021", "table_id": "table-001", "annotation_marker": "t", "annotation_type": "footnote", "annotation_text": "By the investigator according to local practice and according to the guidelines used at the site (Lugano [Cheson et al 2014], Cheson et al 2007, or Cheson et al 1999). Including bone marrow where applicable. If bone marrow data are available in the patient’s medical record that were obtained within 3 months prior to study inclusion, these data can be used instead, and the patient does not need to undergo a new bone marrow biopsy with or without aspirate at screening.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-023" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 27 } ] }, { "annotation_id": "annot-022", "table_id": "table-001", "annotation_marker": "u", "annotation_type": "footnote", "annotation_text": "Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to study entry until 3 months after the final dose of study drug.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-024" ], "cell_references": [ { "activity_id": "act-024", "column_id": "col-002" }, { "activity_id": "act-024", "column_id": "col-003" }, { "activity_id": "act-024", "column_id": "col-004" } ] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 28 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 28, "column_position": 2 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 28, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 28, "column_position": 4 } ] }, { "annotation_id": "annot-023", "table_id": "table-001", "annotation_marker": "v", "annotation_type": "footnote", "annotation_text": "Concomitant medications and adverse events will be collected throughout the study.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-024" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 28 } ] }, { "annotation_id": "annot-024", "table_id": "table-001", "annotation_marker": "w", "annotation_type": "footnote", "annotation_text": "After informed consent has been obtained but prior to initiation of study drug, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study drug, all adverse events will be reported until 3 months (90 days (± 10 days)) after the final dose of study drug. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior study treatment (see Section 5.6). An exception is made for Grade 3–4 infections (related and unrelated), which should be reported until resolution or until up to 2 years after the last dose of obinutuzumab and secondary malignancies should be reported indefinitely. The investigator should follow each adverse event until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the patient is lost to follow-up, or the patient withdraws consent.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-025" ], "cell_references": [ { "activity_id": "act-025", "column_id": "col-002" }, { "activity_id": "act-025", "column_id": "col-003" }, { "activity_id": "act-025", "column_id": "col-004" } ] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 29 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 29, "column_position": 2 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 29, "column_position": 3 }, { "table_number": 1, "location_type": "schedule_cell", "row_position": 29, "column_position": 4 } ], "document_references": [ { "kind": "section", "target": "5.6" } ] }, { "annotation_id": "annot-025", "table_id": "table-001", "annotation_marker": "x", "annotation_type": "footnote", "annotation_text": "After administration of SDI at Cycle 4 Day 1, providers will complete the evaluation of site experience questionnaire.", "annotation_scope": "cell", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [], "cell_references": [ { "activity_id": "act-026", "column_id": "col-008" } ] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 30, "column_position": 8 } ] }, { "annotation_id": "annot-026", "table_id": "table-001", "annotation_marker": "y", "annotation_type": "footnote", "annotation_text": "Before administration of treatment at Day 1 of Cycles 1–6, at the end of induction, during maintenance, at end of maintenance, and at end of study, patients will complete the MDASI. The MDASI will be self-administered before the patient receives any information on disease status, prior to the performance of non-PRO assessments, and prior to the administration of study treatment.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-027" ], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "activity_name", "row_position": 31 } ] }, { "annotation_id": "annot-027", "table_id": "table-001", "annotation_marker": "z", "annotation_type": "footnote", "annotation_text": "LVEF required for patients who receive CHOP only.", "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": 14 } ] }, { "annotation_id": "annot-028", "table_id": "table-001", "annotation_marker": "aa", "annotation_type": "footnote", "annotation_text": "Safety follow-up assessment at 3 months (90 days (+/- 10 days)) after the final dose of obinutuzumab. If a patient discontinues obinutuzumab early and requires another anticancer therapy, then a safety follow up visit must be performed prior to the initiation of the new anticancer therapy.", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-012" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 1, "location_type": "schedule_cell", "row_position": 1, "column_position": 12 } ] } ], "review_items": [ { "id": "D1", "severity": "medium", "location": { "page": 100, "row_positions": [ 24, 25, 26 ] }, "call_made": "'Study drug administration' (a label cell spanning two sub-rows) is recorded as a mark-free parent row (level 0) with two child activities 'obinutuzumab' and 'chemotherapy' (level 1) carrying the marks.", "alternative": "Record two flat level-0 activities named 'Study drug administration – obinutuzumab' and 'Study drug administration – chemotherapy', with no separate parent row.", "report_section": "3.2" }, { "id": "D2", "severity": "medium", "location": { "page": 100, "row_position": 2 }, "call_made": "The second header band (Induction / EOI / Maintenance / EOM) is typed 'period' (sub-phases of Treatment), with EOI and EOM as single-column entries of that band.", "alternative": "Type the band 'visit' or 'other', since EOI and EOM are end-of-phase visits rather than periods; Induction and Maintenance would then be periods mixed in a visit row.", "report_section": "3.3" }, { "id": "D3", "severity": "low", "location": { "page": 100, "row_positions": [ 1, 2, 3, 4 ] }, "call_made": "Header cells that span several header rows vertically (Screening rows 1-3; EOI, Maintenance, EOM rows 2-4; Follow-up rows 1-4) are recorded only on the topmost row they occupy; the covered lower-row cells are empty.", "alternative": "Repeat the label in every header row the cell covers (e.g. 'EOI' also in the Cycle and Day rows).", "report_section": "3.3" } ] }