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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024194-39 |
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The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.
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| Name | Class |
|---|---|
| Fondazione Italiana Linfomi - ETS | OTHER |
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab+Chemotherapy | Active Comparator | Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
|
| Obinutuzumab+Chemotherapy | Experimental | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). | Baseline up to approximately 6.5 years (up to 31 January 2018) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| Ironwood Cancer TX & Rsch Ctrs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39962481 | Derived | Torkaman M, Jemaa S, Fredrickson J, Fernandez Coimbra A, De Crespigny A, Carano RAD. Comparative analysis of intestinal tumor segmentation in PET CT scans using organ based and whole body deep learning. BMC Med Imaging. 2025 Feb 17;25(1):52. doi: 10.1186/s12880-025-01587-3. | |
| 38843483 | Derived | Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6. |
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A total of 1418 patients were randomized and included in the primary analyses (29 April 2016). A total of 1414 patients were included in the final analysis (31 January 2018), 710 in the R-CHOP arm and 704 in the G-CHOP arm; data from 4 patients were excluded because of serious GCP non-compliance at a single study site in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab+Chemotherapy | Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Obinutuzumab | Drug | Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15. |
|
|
| Cyclophosphamide | Drug | Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle. |
|
| Doxorubicin | Drug | Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle. |
|
| Vincristine | Drug | Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle. |
|
| Prednisone | Drug | Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle. |
|
| Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
| Median Time to Overall Survival (OS) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. | Baseline up to approximately 6.5 years (up to 31 January 2018) |
| Overall Response Rate (ORR), Investigator-Assessed | Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. | Baseline up to approximately 6.5 years (up to 31 January 2018) |
| Overall Response Rate (ORR), IRC-Assessed | Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
| Complete Response (CR) at the End of Treatment, Investigator-Assessed | Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. | Baseline up to approximately 6.5 years (up to 31 January 2018) |
| Complete Response (CR) at the End of Treatment, IRC-Assessed | Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
| Median Time to Event-Free Survival (EFS), Investigator-Assessed | Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
| Median Time to Disease-Free Survival (DFS), Investigator-Assessed | Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
| Duration of Response (DOR), Investigator-Assessed | DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
| Time to Next Anti-Lymphoma Treatment (TTNALT) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. | Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018) |
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to approximately 6.5 years (up to 31 January 2018) |
| Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants. | Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score | The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. | Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. | Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days) |
| Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) | Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab. | C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days) |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Arizona Oncology | Tucson | Arizona | 85704 | United States |
| California Cancer Associates for Research & Excellence, Inc. | Encinitas | California | 92008 | United States |
| cCare | Encinitas | California | 92024 | United States |
| UCLA - School of Medicine; Division of Hematology/Oncology | Los Angeles | California | 90095-6984 | United States |
| Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | 80012 | United States |
| Florida Cancer Specialists; Department of Oncology | Fort Myers | Florida | 33901-8101 | United States |
| Florida Cancer Specialists; Saint Petersburg | St. Petersburg | Florida | 33719 | United States |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | United States |
| Illinois Cancer Care, P.C. - Galesburg | Galesburg | Illinois | 61401 | United States |
| Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Cancer Care & Hematology; Specialists of Chicagoland | Niles | Illinois | 60714 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Mercy Oncology / Hematology Center; Oncology | Portland | Maine | 04102 | United States |
| Park Nicollet Clin-Cancer Ctr | Saint Louis Park | Minnesota | 55426 | United States |
| Minnesota Oncology Hematology Woodbury | Woodbury | Minnesota | 55125 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Mecklenburg Medical Group Charlotte | Charlotte | North Carolina | 28204 | United States |
| Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates | Winston-Salem | North Carolina | 27103 | United States |
| Signal Point Clinical; Research Center, LLC | Middletown | Ohio | 45042 | United States |
| Cleveland CL N Coast Cancer Cr | Sandusky | Ohio | 44870 | United States |
| Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon | 97477 | United States |
| Medical University of SC (MUSC) | Charleston | South Carolina | 29425 | United States |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | United States |
| Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Onc., PLLC - SCRI | Nashville | Tennessee | 37203 | United States |
| Texas Oncology, Pa - Amarillo | Amarillo | Texas | 79106 | United States |
| Texas Oncology-Fort Worth 12th Ave | Fort Worth | Texas | 76104 | United States |
| MD Anderson Cancer Center Department of Lymphoma & Myeloma | Houston | Texas | 77030 | United States |
| Cancer Care Centers of South Texas-HOAST - San Antonio | New Braunfels | Texas | 78130 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Virginia Cancer Specialists - Winchester | Winchester | Virginia | 22601 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | United States |
| Instituto Damic | Córdoba | X5003DCE | Argentina |
| Sanatorio Britanico: Hematologia | Rosario | 2000 | Argentina |
| Sanatorio Parque de Rosario | Rosario | S2000DSV | Argentina |
| Cairns Base Hospital; Cancer Care Centre | Cairns | Queensland | 4870 | Australia |
| Frankston Hospital; Oncology/Haematology | Frankston | Victoria | 3199 | Australia |
| Monash Medical Centre; Haematology | Melbourne | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie | Innsbruck | 6020 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie | Vienna | 1090 | Austria |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro de Pesquisas Oncologicas - CEPON | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Instituto de Ensino e Pesquisa Sao Lucas - IEP | São Paulo | São Paulo | 01236-030 | Brazil |
| Hospital Santa Marcelina;Oncologia | São Paulo | São Paulo | 08270-070 | Brazil |
| Tom Baker Cancer Centre; Dept of Medicine | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| North York General Hospital | Toronto | Ontario | M2J 1V1 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve- Rosemont; Oncology | Montreal | Quebec | H1T 2M4 | Canada |
| Chum Hopital Notre Dame; Centre D'Oncologie | Montreal | Quebec | H2L 4M1 | Canada |
| Mcgill University - Royal Victoria Hospital; Oncology | Montreal | Quebec | H3A 1A1 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital de L'Enfant-Jesus; Hematology | Québec | Quebec | G1J 1Z4 | Canada |
| Centre de sante et de services sociaux Rimouski Neigette | Rimouski | Quebec | G5L 5T1 | Canada |
| Saskatoon Cancer Centre; Uni of Saskatoon Campus | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Beijing Hospital of Ministry of Health; Hematology | Beijing | 100730 | China |
| General Hospital of Chinese PLA; Department of Hematology | Beijing | 100853 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Hu Nan Provincial Cancer Hospital | Changsha | 410006 | China |
| Fujian Medical University Union Hospital | Fujian | 350001 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| The Second Affiliated Hospital to Nanchang University | Nanchang | 330006 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Jiangsu Province Hospital | Nanjing | 210036 | China |
| The First Affiliate Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Changhai Hospital of Shanghai | Shanghai | 200433 | China |
| First Hospital of China Medical University | Shenyang | 110001 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | 215004 | China |
| First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430022 | China |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center | Wuhan | 430023 | China |
| The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) | Xi'an | 710038 | China |
| Fundacion Cardioinfantil | Bogotá | Colombia |
| Organizacion Sanitas Internacional | Bogotá | Colombia |
| FOSCAL | Floridablanca | Colombia |
| Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika | Brno | 625 00 | Czechia |
| Fn Hr. Kralove; IV. Interni Hematologicka Klinika | Hradec Králové | 500 05 | Czechia |
| Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK | Prague | 128 08 | Czechia |
| Aarhus Universitetshospital, Hæmatologisk Afdeling R | Aarhus | 8000 | Denmark |
| Rigshospitalet; Hæmatologisk Klinik | København Ø | 2100 | Denmark |
| Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium | Roskilde | 4000 | Denmark |
| Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz | Aachen | 52074 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I | Dresden | 01307 | Germany |
| Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V | Erlangen | 91054 | Germany |
| Klinik der Justus-Liebig-Universität; Innere Medizin | Giessen | 35392 | Germany |
| Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V | Heidelberg | 69120 | Germany |
| Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie | Würzburg | 97080 | Germany |
| Pamela Youde Nethersole Eastern Hospital; Department of Medicine | Hong Kong | Hong Kong |
| Queen Mary Hospital; Dept of Medicine | Hong Kong | Hong Kong |
| Semmelweis University, First Dept of Medicine | Budapest | 1083 | Hungary |
| National Institute of Oncology, A Dept of Internal Medicine | Budapest | 1122 | Hungary |
| University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Korhaz; Hematologia | Győr | 9024 | Hungary |
| Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology | Kaposvár | 7400 | Hungary |
| University of Pecs, I st Dept of Internal Medicine | Pécs | 7624 | Hungary |
| University of Szeged, II Dept of Internal Medicine | Szeged | 6720 | Hungary |
| Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica | Bari | Apulia | 70124 | Italy |
| IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo | San Giovanni Rotondo | Apulia | 71013 | Italy |
| Az. Osp. C. Panico; Rep. Ematologia E Trapianto | Tricase - LE | Apulia | 73039 | Italy |
| Ospedale Riuniti; Divisione Di Ematologia | Reggio Calabria | Calabria | 89100 | Italy |
| Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica | Naples | Campania | 80131 | Italy |
| Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia | Naples | Campania | 80131 | Italy |
| Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia | Pagani (Sa) | Campania | 84016 | Italy |
| A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna | Bologna | Emilia-Romagna | 40138 | Italy |
| AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol | Rome | Lazio | 00161 | Italy |
| A.O. Universitaria S. Martino Di Genova; Ematologia 1 | Genoa | Liguria | 16132 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia | Brescia | Lombardy | 25123 | Italy |
| Hospital San Raffaele | Milan | Lombardy | 20132 | Italy |
| Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia | Milan | Lombardy | 20141 | Italy |
| Irccs Policlinico San Matteo; Divisione Di Ematologia | Pavia | Lombardy | 27100 | Italy |
| Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia | Alessandria | Piedmont | 15121 | Italy |
| Ospedali Riuniti del Canavese | Ivrea | Piedmont | 10015 | Italy |
| Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad | Novara | Piedmont | 28100 | Italy |
| Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii | Orbassano | Piedmont | 10043 | Italy |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1 | Turin | Piedmont | 10126 | Italy |
| A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliero Univ | Catania | Sicily | 95124 | Italy |
| Az. Osp. Papardo; Struttura Complessa Di Ematologia | Messina | Sicily | 98165 | Italy |
| Azienda Ospedaliera Univ | Florence | Tuscany | 50141 | Italy |
| Ospedale Santa Chiara; Unita Operativa Di Ematologia | Pisa | Tuscany | 56100 | Italy |
| Az. Osp. S. Maria; Dept. Di Oncologia Medica | Terni | Umbria | 05100 | Italy |
| Ospedale Ca Foncello; Ematologia | Treviso | Veneto | 31100 | Italy |
| Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia | Verona | Veneto | 37130 | Italy |
| Ospedale Di Vicenza; Nefrologia, Ematologia | Vicenza | Veneto | 36100 | Italy |
| Nagoya Daini Red Cross Hospital; Hematology & Oncology | Aichi | 466-8650 | Japan |
| Chiba University Hospital; Hematology | Chiba | 260-8670 | Japan |
| Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine | Fukuoka | 812-8582 | Japan |
| Kurume University Hospital; Hematology and Oncology | Fukuoka | 830-0011 | Japan |
| Gifu University Hospital; First Department of Internal Medicine | Gifu | 501-1194 | Japan |
| Hokkaido University Hospital; Hematology | Hokkaido | 060-8648 | Japan |
| Kobe City Medical Center General Hospital; Hematology | Hyōgo | 650-0047 | Japan |
| Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease | Kanagawa | 236-0004 | Japan |
| Kyoto University Hospital; Department of Hematology/Oncology | Kyoto | 606-8507 | Japan |
| Niigata Cancer Center Hospital; Internal Medicine | Niigata | 951-8566 | Japan |
| Iwate Medical University Hospital;Hematology and Oncology | Numakunai | 020-8505 | Japan |
| Kurashiki Central Hospital; Hematology | Okayama | 710-8602 | Japan |
| Osaka City University Hospital; Hematology | Osaka | 545-8586 | Japan |
| Osaka University Hospital; Hematology and Oncology | Osaka | 565-0871 | Japan |
| Kindai University Hospital; Hematology and Rheumatology | Osaka | 589-8511 | Japan |
| Shimane University Hospital;Hematology | Shimane | 693-8501 | Japan |
| Jichi Medical University Hospital; Hematology | Tochigi | 329-0498 | Japan |
| National Cancer Center Hospital; Hematology | Tokyo | 104-0045 | Japan |
| Toranomon Hospital; Hematology | Tokyo | 105-8470 | Japan |
| Nippon Medical School Hospital; Hematology | Tokyo | 113-8603 | Japan |
| The Cancer Institute Hospital of JFCR; Hematology Oncology | Tokyo | 135-8550 | Japan |
| Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre | Chihuahua City | 31000 | Mexico |
| Hospital Universitario Dr. Jose E. Gonzalez; Haematology | Monterrey | 64460 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Centro de Estudios Clinicos de Queretaro, SC | Querétaro | 76000 | Mexico |
| Centro Hemato Oncologico Panama | Panama City | 0832 | Panama |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 15038 | Peru |
| Instituto;Oncologico Miraflores | Lima | 18 | Peru |
| Clinica de Especialidades Medicas | Lima | Lima 41 | Peru |
| Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny | Brzozów | 36-200 | Poland |
| Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii | Gdansk | 80-952 | Poland |
| Medical University of Lodz; Hematology | Lodz | 93-510 | Poland |
| Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie | Lublin | 20-081 | Poland |
| Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego | Warsaw | 02-781 | Poland |
| Medical Uni of Wroclaw; Hematology | Wroclaw | 50-367 | Poland |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| Blokhin Cancer Research Center; Clinical Oncology | Moscow | 115478 | Russia |
| Regional Clinical Hospital N.A. Semashko; Hematology | Nizhny Novgorod | 603126 | Russia |
| Penza Regional Oncology Dispensary | Penza | 440071 | Russia |
| Republican Clinical Hospital n.a. Baranov; Haematology | Petrozavodsk | 185019 | Russia |
| Research Inst. of Hematology & Blood Transfusion ; Hematology | Saint Petersburg | 191024 | Russia |
| Institute of Hematology | Belgrade | 11000 | Serbia |
| Clinical Center Vojvodine; Clinic for Hematology | Novi Sad | 21000 | Serbia |
| National Oncology Inst. ; Dept. of Haematology | Bratislava | 833 10 | Slovakia |
| Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant | Cape Town | 7800 | South Africa |
| Mary Potter Oncology Centre | Groenkloof | 0181 | South Africa |
| Medical Oncology Centre of Rosebank; Oncology | Johannesburg | 2196 | South Africa |
| Wits Donald Gordon Clinical Trial Centre; Medical Oncology | Parktown, Johannesburg | 2193 | South Africa |
| Drs Thomson, Brittain an Partners Inc | Pretoria | 0044 | South Africa |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center - Oncology | Seoul | 05505 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine | Seoul | 137-701 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| Hospital de Navarra, Servicio de Hematología | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Sant Joan de Reus; Servicio de Oncologia | Reus | Tarragona | 43204 | Spain |
| Hospital del Mar; Servicio de Hematologia | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron; Servicio de Hematologia | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Hospital Duran i Reynals; Servicio de Hematologia | Barcelona | 08907 | Spain |
| Hospital Ramon y Cajal; Servicio de Hematologia | Madrid | 28034 | Spain |
| Complejo Hospitalario de Pontevedra; Servicio de Oncologia | Pontevedra | 36002 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Oncologia | Seville | 41009 | Spain |
| Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Toledo | 45004 | Spain |
| Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin | Aarau | 5001 | Switzerland |
| Ospedale San Giovanni; Oncologia | Bellinzona | 6500 | Switzerland |
| Kantonsspital Graubünden;Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zurich | 8091 | Switzerland |
| Veterans General Hospital; Division of Oncology | Taipei | 00112 | Taiwan |
| National Taiwan Universtiy Hospital; Division of Hematology | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine | Bangkok | 10330 | Thailand |
| National Cancer Inst. | Bangkok | 10400 | Thailand |
| Rajavithi Hospital; Medicine | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital; Division of Hematology, Department of Medicine | Bangkok | 10400 | Thailand |
| Siriraj Hospital; Division of Hematology, Department of Medicine | Bangkok | 10700 | Thailand |
| Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine | Khon Kaen | 40002 | Thailand |
| Aberdeen Royal Infirmary; Haematology - Ward 16 | Aberdeen | AB25 2ZN | United Kingdom |
| Birmingham Heartlands Hospital; Department of Haematology | Birmingham | B9 5SS | United Kingdom |
| Addenbrookes Hospital; Haematology | Cambridge | CB2 0QQ | United Kingdom |
| The HOPE Clinical Trials Unit | Leicester | LE1 5WW | United Kingdom |
| New Cross Hospital; Dept. Of Haematology | Wolverhampton | WV10 0QP | United Kingdom |
| 38498084 | Derived | Yan JT, Bel C, Trask PC, Lo E. Are changes in patient-reported outcomes prognostic for diffuse large B-Cell lymphoma survival? Results from the GOYA trial. J Patient Rep Outcomes. 2024 Mar 18;8(1):31. doi: 10.1186/s41687-024-00708-w. |
| 37702406 | Derived | Ho RS, Launonen A. Comparison of statistical methods for extrapolating survival in previously untreated diffuse large B-cell lymphoma: results based on the POLARIX study. J Med Econ. 2023 Jan-Dec;26(1):1178-1189. doi: 10.1080/13696998.2023.2259107. Epub 2023 Sep 13. |
| 35962459 | Derived | Jemaa S, Paulson JN, Hutchings M, Kostakoglu L, Trotman J, Tracy S, de Crespigny A, Carano RAD, El-Galaly TC, Nielsen TG, Bengtsson T. Full automation of total metabolic tumor volume from FDG-PET/CT in DLBCL for baseline risk assessments. Cancer Imaging. 2022 Aug 12;22(1):39. doi: 10.1186/s40644-022-00476-0. |
| 34323958 | Derived | Nowicka M, Hilton LK, Ashton-Key M, Hargreaves CE, Lee C, Foxall R, Carter MJ, Beers SA, Potter KN, Bolen CR, Klein C, Knapp A, Mir F, Rose-Zerilli M, Burton C, Klapper W, Scott DW, Sehn LH, Vitolo U, Martelli M, Trneny M, Rushton CK, Slack GW, Farinha P, Strefford JC, Oestergaard MZ, Morin RD, Cragg MS. Prognostic significance of FCGR2B expression for the response of DLBCL patients to rituximab or obinutuzumab treatment. Blood Adv. 2021 Aug 10;5(15):2945-2957. doi: 10.1182/bloodadvances.2021004770. |
| 34323957 | Derived | Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985. |
| 33651099 | Derived | Kostakoglu L, Martelli M, Sehn LH, Belada D, Carella AM, Chua N, Gonzalez-Barca E, Hong X, Pinto A, Shi Y, Tatsumi Y, Knapp A, Mattiello F, Nielsen T, Sahin D, Sellam G, Oestergaard MZ, Vitolo U, Trneny M. End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA. Blood Adv. 2021 Mar 9;5(5):1283-1290. doi: 10.1182/bloodadvances.2020002690. |
| 33054054 | Derived | Bolen CR, Klanova M, Trneny M, Sehn LH, He J, Tong J, Paulson JN, Kim E, Vitolo U, Di Rocco A, Fingerle-Rowson G, Nielsen T, Lenz G, Oestergaard MZ. Prognostic impact of somatic mutations in diffuse large B-cell lymphoma and relationship to cell-of-origin: data from the phase III GOYA study. Haematologica. 2020 Sep 1;105(9):2298-2307. doi: 10.3324/haematol.2019.227892. |
| 32505213 | Derived | Sehn LH, Martelli M, Trneny M, Liu W, Bolen CR, Knapp A, Sahin D, Sellam G, Vitolo U. A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA. J Hematol Oncol. 2020 Jun 6;13(1):71. doi: 10.1186/s13045-020-00900-7. |
| 31053601 | Derived | Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3. |
| 30770362 | Derived | McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602. |
| 30617197 | Derived | Klanova M, Sehn LH, Bence-Bruckler I, Cavallo F, Jin J, Martelli M, Stewart D, Vitolo U, Zaja F, Zhang Q, Mattiello F, Sellam G, Punnoose EA, Szafer-Glusman E, Bolen CR, Oestergaard MZ, Fingerle-Rowson GR, Nielsen T, Trneny M. Integration of cell of origin into the clinical CNS International Prognostic Index improves CNS relapse prediction in DLBCL. Blood. 2019 Feb 28;133(9):919-926. doi: 10.1182/blood-2018-07-862862. Epub 2019 Jan 7. |
| 30341058 | Derived | Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19. |
| FG001 |
| Obinutuzumab+Chemotherapy |
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
| COMPLETED |
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| NOT COMPLETED |
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The intent-to-treat (ITT) population included all randomized participants. However, 4 patients were classified as misconduct patients and were not included in the ITT population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab+Chemotherapy | Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
| BG001 | Obinutuzumab+Chemotherapy | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
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| Secondary | Median Time to Overall Survival (OS) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Overall Response Rate (ORR), Investigator-Assessed | Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Number | percentage of participants | Baseline up to approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Overall Response Rate (ORR), IRC-Assessed | Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
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| Secondary | Complete Response (CR) at the End of Treatment, Investigator-Assessed | Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Number | percentage of participants | Baseline up to approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Complete Response (CR) at the End of Treatment, IRC-Assessed | Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) |
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| Secondary | Median Time to Event-Free Survival (EFS), Investigator-Assessed | Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Mean | 95% Confidence Interval | months | Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Median Time to Disease-Free Survival (DFS), Investigator-Assessed | Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. | The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Duration of Response (DOR), Investigator-Assessed | DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. | The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Time to Next Anti-Lymphoma Treatment (TTNALT) | Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018) |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Number | percentage of participants | Baseline up to approximately 6.5 years (up to 31 January 2018) |
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| Secondary | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants. | The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non- compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Number | percentage of participants | Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score | The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. | The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. | The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days) |
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| Secondary | Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) | Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab. | The Pharmacokinetic assessment was done on a subset of 39 Japanese participants in the Obinutuzumab+Chemotherapy arm only. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days) |
|
|
6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab+Chemotherapy | Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. | 269 | 701 | 613 | 701 | ||
| EG001 | Obinutuzumab+Chemotherapy | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. | 312 | 702 | 646 | 702 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Splenic haematoma | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiac perforation | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ventricular flutter | Cardiac disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Addison's disease | Endocrine disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hepatitis B Reactivation | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infective glossitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Prostatic abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Tuberculosis of central nervous system | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| HIV antibody positive | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Marginal zone lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Papillary cystadenoma lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Tumour perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Iiird nerve paralysis | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cystitis glandularis | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Venous occlusion | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bone Marrow Failure | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Anorectal cellulitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Angioimmuoblastic T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Squamous cell carincoma of pharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C543332 | obinutuzumab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
|
| OG001 |
| Obinutuzumab+Chemotherapy |
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
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| OG001 | Obinutuzumab+Chemotherapy | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
|
|
| OG001 | Obinutuzumab+Chemotherapy | Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. |
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