NCT03817853 — consolidated Schedule of Activities

usdm_data · 1 tables · 27 activities (0% compression) · 11 columns · study-schedule-consolidated v1.0 · Layer 3
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▼ Main Schedule (11 columns)
ActivityInTable 1
Study period
[epoch] L1		Screening2Screening2Treatment3Treatment3Treatment3Treatment3Treatment3TreatmentTreatment6TreatmentFollow-up (3 months)28
Treatment phase
[period] L2		Induction (6–8 cycles)Induction (6–8 cycles)Induction (6–8 cycles)Induction (6–8 cycles)Induction (6–8 cycles)EOIMaintenance (every 8 weeks ± 10 days)EOM
Cycle
[cycle] L3		Cycle 1Cycle 1Cycle 1Cycle 2Cycles 3–6/8
Day
[study_day] L4		D–28 to D–1D–7 to D–1D1D8D15D1D1
Informed consentT1x7
Demographic dataT1x
Medical history and baseline conditionsT1x
Ann Arbor, FLIPI, and FLIPI2T1x
ECOG performance statusT1x
Vital signs8T1xxxxxxxxxx
WeightT1x
HeightT1x
ECGT1x
LVEF (echocardiography or MUGA scan)27T1x
Complete physical examination9,10T1xx
Targeted physical examination11,12T1xx
B symptoms13T1x
Hematology14T1xxxxxxxxx
Chemistry15T1xxxxxxxx
Pregnancy test16T1x
Coagulation INR, aPTT or PTT and PTT1x
Urinalysis17T1xxx
HIV, HTLV-1, Hep B / C testing18T1x
Study drug administrationT1
obinutuzumab19T1x4x4x4x5x5x5
chemotherapy20T1xxx
Tumor assessment21T1xxx
Concomitant medications23T1x22x22x22xxxxxxxx
Adverse eventsT1x24x24x24xxxxxxxx
Provider-reported measuresT1x25
Patient-reported measures26T1xxxxxxx
▼ Matches across tables no matches to review
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT03817853_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
Draft — new file consolidated/NCT03817853_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:33.239147+00:00
source_activity_count27
unified_activity_count27
compression_percent0
match_statsnew: 27
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Appendix 1 Schedule of Activities
Main study schedule: screening, induction (G-chemo), end of induction, maintenance, end of maintenance and safety follow-up		 27 11 4
▼ Unified Activities 27 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent one table 1 T1
xact-002 Demographic data one table 1 T1
xact-003 Medical history and baseline conditions one table 1 T1
xact-004 Ann Arbor, FLIPI, and FLIPI2 one table 1 T1
xact-005 ECOG performance status one table 1 T1
xact-006 Vital signs one table 1 T1
xact-007 Weight one table 1 T1
xact-008 Height one table 1 T1
xact-009 ECG one table 1 T1
xact-010 LVEF (echocardiography or MUGA scan) one table 1 T1
xact-011 Complete physical examination one table 1 T1
xact-012 Targeted physical examination one table 1 T1
xact-013 B symptoms one table 1 T1
xact-014 Hematology one table 1 T1
xact-015 Chemistry one table 1 T1
xact-016 Pregnancy test one table 1 T1
xact-017 Coagulation INR, aPTT or PTT and PT one table 1 T1
xact-018 Urinalysis one table 1 T1
xact-019 HIV, HTLV-1, Hep B / C testing one table 1 T1
xact-020 Study drug administration one table 1 T1 section
xact-021 obinutuzumab Study drug administration one table 1 T1
xact-022 chemotherapy Study drug administration one table 1 T1
xact-023 Tumor assessment one table 1 T1
xact-024 Concomitant medications one table 1 T1
xact-025 Adverse events one table 1 T1
xact-026 Provider-reported measures one table 1 T1
xact-027 Patient-reported measures one table 1 T1
▼ Unified Annotations 28 annotations (0% dedup from 28)
Footnote (28)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:gn1 1 Notes: Dosing (i.e., Day 1 of each cycle), in induction phase should be done within ± 2 days of the scheduled visit date, with the exception of C1D1 which should take place within 28 days of the patient entering screening. All assessments should be performed within 2 days of the scheduled visit, unless otherwise specified. On treatment days, all assessments should be performed prior to dosing, unless otherwise specified. Results from hematology and biochemistry must be reviewed, and the review documented, prior to study drug administration. table
xannot-002 2 T1:a 1 Results of standard-of-care tests or examinations performed prior to obtaining informed consent and within the defined window may be used; such tests do not need to be repeated for screening. D–28 to D–1 | D–7 to D–1
xannot-003 3 T1:b 1 The total number of cycles of G-chemo indication therapy and the cycles length depends on the chemotherapy chosen for each patient (see Section 4.3.2.2 Combination chemotherapy). Cycle 1 | Cycle 1 | Cycle 1 | Cycle 2 | Cycles 3–6/8 Section 4.3.2.2
xannot-004 4 T1:c 1 Obinutuzumab administered according to the regular infusion rate (see Table 1, Section 3.1). obinutuzumab 3 cells Section 3.1 · Table 1
xannot-005 5 T1:d 1 Obinutuzumab administered according a 90-minute short duration infusion (see Table 1, Section 3.1) for patients who do not experience any Grade ≥3 IRRs during the first or previous cycle. 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. obinutuzumab 3 cells Section 3.1 · Table 1
xannot-006 6 T1:e 1 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. Treatment
xannot-007 7 T1:f 1 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. Informed consent 1 cells
xannot-008 8 T1:g 1 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. Vital signs
xannot-009 9 T1:h 1 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. Complete physical examination
xannot-010 10 T1:i 1 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. Complete physical examination
xannot-011 11 T1:j 1 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. Targeted physical examination
xannot-012 12 T1:k 1 Perform at the same time as tumor assessments after the end of induction treatment. Targeted physical examination
xannot-013 13 T1:l 1 Unexplained fever >38ºC, night sweats, unexplained weight loss >10% of body weight over 6 months. B symptoms
xannot-014 14 T1:m 1 Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, other cells). Hematology
xannot-015 15 T1:n 1 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. Chemistry
xannot-016 16 T1:o 1 All women of childbearing potential will have a serum pregnancy test at screening. Pregnancy test
xannot-017 17 T1:p 1 Includes dipstick (pH, specific gravity, glucose, protein, ketones, blood) and microscopic examination if routinely performed (sediment, RBCs, WBCs, casts, crystals, epithelial cells, bacteria). Urinalysis
xannot-018 18 T1:q 1 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. HIV, HTLV-1, Hep B / C testing
xannot-019 19 T1:r 1 Obinutuzumab administered on Days, 1, 8 and 15 of cycle 1 and Day 1 of subsequent cycles. obinutuzumab
xannot-020 20 T1:s 1 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. chemotherapy Section 4.3.2.2
xannot-021 21 T1:t 1 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. Tumor assessment
xannot-022 22 T1:u 1 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. Concomitant medications 3 cells
xannot-023 23 T1:v 1 Concomitant medications and adverse events will be collected throughout the study. Concomitant medications
xannot-024 24 T1:w 1 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. Adverse events 3 cells Section 5.6
xannot-025 25 T1:x 1 After administration of SDI at Cycle 4 Day 1, providers will complete the evaluation of site experience questionnaire. Provider-reported measures 1 cells
xannot-026 26 T1:y 1 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. Patient-reported measures
xannot-027 27 T1:z 1 LVEF required for patients who receive CHOP only. LVEF (echocardiography or MUGA scan)
xannot-028 28 T1:aa 1 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. Follow-up (3 months)